Miscellaneous Conditions

This study will look at who does not improve after doing a behavioral parent training program briefly through telehealth. It will also study ways to make the intervention better for those that do not improve.

The objective of the BASIS R34 pilot study is to test the impact of eBASIS in a randomized controlled trial (RCT). Consistent with IMPACT's IQM, the study tests effects of eBASIS on treatment fidelity and youth outcomes, compared to a digitally delivered control (N=32 clinicians; 96 clients). A well-established EBP (Cognitive Behavioral Therapy Plus), will be a focus of the investigation, which eligible participants will already be signed up to receive.

Self-control failures are a universal challenge for healthy and clinical populations. Recent work suggests these failures may arise from excessive cognitive costs associated with exercising self-control, yet the mechanisms underlying these costs are unknown. To address this, the investigators will use a validated decision-making task that measures how much individuals will pay (from a study endowment) to restrict access to tempting rewards that may lead to self-control failures. The investigators will examine these costs to identify their cognitive, neural and affective mechanisms. First, the investigators will identify the cognitive and computational mechanism that gives rise to self-control costs. Second, the investigators will characterize the neural correlates of self-control costs and identify neural mediators and connectivity patterns stemming from these costs. Finally, the investigators will examine how different classes of stressors (physical, social, or lifetime stress) shape the behavioral and neural representations of self-control costs.

This is a randomized clinical trial of Focused Acceptance and Commitment Therapy (FACT) vs. an attention-control condition (placebo) for improving the mental health of parents of children with pediatric feeding disorder.

The goal of this clinical trial is to compare two programs in parents of children with pediatric feeding disorders.

The main question\[s\] it aims to answer are:

FACT will result in clinically meaningful reductions in Mental Health(MH) problems among parents of children with Pediatric Feed Disorder (PFD) Identify factors that impact the feasibility of FACT delivery

Participants will asked to participate in one of two programs focused on parents of children with pediatric feeding disorders. The participants will also be asked to complete a battery of questionnaires at four timepoints during the study. The parents will be asked to video record a meal time three times during study.

Researchers will compare the FACT group with a control group to see if FACT will result in clinically meaningful change in parent stress and anxiety, and parent use of positive mealtime behaviors.

The goal of this research is to develop a new breathing feature on the meditation app, Equa, to help young adults who are distressed, understand their physiological responses and mindfulness skill development during meditation.

Our main aims are to build an algorithm that can use respiration signals (i.e., breathing) to:

* Give feedback about how participant physiology is changing during guided lessons on the meditation app, Equa * Measure how much participant mindfulness skills are improving

Participants will:

* Complete a survey about demographics, their thoughts and feelings before and after the mindfulness meditation program * Complete 14 smartphone guided mindfulness meditation training units while physiological measures are being recorded * Complete a few brief questionnaires before and after mindfulness practices to understand potential changes in their mindfulness skills

Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.

Music Mindfulness Study: Investigators will compare the effects of music-backed guided mindfulness mediation and guided mediation alone in alleviating anxiety and depression.

Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.

2c.a. Drum Circle Synchrony Study: This study will investigate the role that synchrony plays in subjective feelings of connection.

Mental health vulnerability due to stress is increased America due to disproportionate effects of social factors such as racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of Persons of African Descent(PAD) or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.

Component 2c. Drum Circle Study: Investigators will study the impact of participation in drum circles on anxiety and feelings of connectedness.

Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.

Component 2d. Social Perception Tasks: Participants may be asked to take part in social perception tasks in which they will be asked to indicate their social perception and connection felt with various partners.

Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.

2b. Social Music Study: Investigators will assess the neural mechanisms of feelings of subjective connectedness during communal music listening and creating between dyads of subjects who are both familiar and unfamiliar with each other.

The goal of this clinical trial is to test an app-based just-in-time-adaptive intervention (JITAI). The intervention aims to improve child and family mental health. A JITAI provides in-the-moment feedback to coach families. The questions it tests are if the app will improve mental health and family functioning. Participants will download an app on their phone and complete JITAI sessions. Researchers will compare intervention and control groups to see if the app improves mental health.

The goal of this clinical trial is to develop non-invasive brain stimulation targets for the treatment of apathy, or motivation problems, in Parkinson Disease.

The main questions the study aims to answer are:

1. Does transcranial magnetic stimulation change effort task performance in Parkinson's Disease patients? 2. Is there a link between brain signals and apathy?

Participants will

* complete questionnaires and assessments * perform an effort task * have their brain activity recorded (EEG) * receive non-invasive brain stimulation (TMS)

Researchers will compare two stimulation locations (experimental site and control site) to see if TMS of the experimental site has an effect on apathy. Participants will receive stimulation of both sites (during separate visits).

This study seeks to respond to the growing burden of adolescent mental health disorders and urgent preventive service needs in Kenya by studying the effectiveness of a digital health intervention- mobile health (mHealth) Toolkit for Screening \& Empowering Lives of Youth (mSELY)-that has demonstrated feasibility from our prior pilot study. The investigators will build on this work and examine two versions of mSELY. The mSELY-A is designed for adolescents to self-evaluate and manage psychological wellbeing/mental health needs, as well as to gain resources and access and connect with adolescent peers. The mSELY-P is designed for parents to self-evaluate their adolescent's development and mental health, gain awareness about their adolescent's mental health status, and learn strategies and resources to support adolescents' mental health. Both versions provide screening, tailored mental health literacy materials, and decision support for adolescents and/or their parents. This study will examine the effectiveness of these digital interventions using a randomized control trial with diverse community-based organizations in Kenya. In addition, the investigators will study underlying mechanisms that contribute to intervention effectiveness, as well as to use the data for precision medicine analysis (using machine learning approach). Findings will be used to improve Digital-Toolkit decision support functions and accuracy of mental health precision care.

The goal of this clinical trial is to conduct a preliminary test of the effectiveness of Forging New Paths for people with mental illness with criminal legal system contact. The main question\[s\] it aims to answer are:

1. To examine the effectiveness of Forging New Paths at improving the primary study outcomes (aggression and community tenure). 2. To test the ability of Forging New Paths to engage the study treatment targets (impulsivity and criminal attitudes)

Participants will complete a screening interviews to see if they are eligible. Participants who are eligible will be randomly assigned to participate in one of two study conditions: Forging New Paths and usual care or usual care alone. All participants who are assigned to a study condition will participate in up to three additional research interviews. Researchers will also collect information about study outcomes using administrative records.

The goal of this randomized clinical trial is to compare the effects of an online mindfulness program to an active supportive comparison condition and a no-intervention control group on reducing and preventing mood and anxiety symptoms in at-risk youth. Youth who are high on trait negative affect will be randomized to one of the three conditions. The primary outcomes of interest are reductions in momentary negative affect and internalizing problems in adolescents ages 12 to 17 years old. All participants will be evaluated prior to being randomized, after the 9-session intervention period, and at a 6-month follow-up.

The first hypothesis is that the mindfulness intervention will predict decreases in stressor-reactive momentary negative affect and internalizing symptoms. The second hypothesis is that changes in momentary negative affect will partially account for the effects of the mindfulness intervention on internalizing symptoms.

The goal of this basic experimental clinical trial is to understand the effect of multitasking practice on the structure of neural representations of tasks in the human lateral prefrontal cortex and control brain regions. The main question it aims to answer is: What changes in neural representational structure predict improvements in multitasking behavior due to multitasking practice? Healthy human participants will learn two independent tasks, each mapping a set of stimuli to motor responses based on different rules. Participants will be randomized to one of two interventions. Participants assigned to the multitask practice intervention (MPI) will practice multitasking the two tasks over multiple days. Those assigned to the single-task practice intervention (SPI) will instead practice each task separately while controlling for the total number of practice opportunities associated with each task across the interventions. Both before and after the practice, the ability of all participants to perform both tasks simultaneously will be behaviorally measured using a well-established psychological refractory period (PRP) paradigm, and their neural representations will be measured using functional MRI while they perform the two tasks. Researchers will then compare improvements in multitasking behavior across the two groups, as well as changes in neural representational geometry of the tasks in the lateral prefrontal cortex and control brain regions, and test whether multitasking training is associated with specific changes in neural representations in the lateral prefrontal cortex.

This project, SCALE, will be the first to compare lower-intensity (standard) and higher-intensity implementation strategies to deliver GlobalConsent-an efficacious web-based sexual violence prevention program-to men attending six universities across Vietnam. Following a rigorous, mixed-methods, comparative interrupted-time-series design, researchers will collect novel data to compare implementation fidelity, drivers and outcomes, effectiveness, and cost-effectiveness across implementation strategy groups. This partnership includes universities also engaged in a violence-prevention training grant (D43TW012188), offering an unparalleled opportunity for capacity strengthening and evidence generation to guide national leaders on best strategies for launching GlobalConsent at scale, to address a gendered risk factor in adolescence, and thereby, improve an array of health outcomes into adulthood.

The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no correlated epileptiform activity). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of either ReACT or supportive therapy. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C), pain tolerance (time with hand in water) and cortisol response. Target assessments occur 7 days before treatment, 7 days after 12th treatment session, and 2 months after the 12th treatment session. Long term follow-up assessments will occur 6 months and 12 months after the 12th treatment session. PNES frequency will be measured from 30 days before to 12 months after treatment.

Although there is increasing recognition that the cerebellum is involved in cognition as well as motor function, the manner in which the cerebellum contributes to cognition is uncertain. One theory that might account for both motor and cognitive contributions of the cerebellum is that the cerebellum is involved in sequencing of relevant events or stimuli. Previous experiments have suggested that disruption of the cerebellum impairs the prediction of the next event in a sequence. The present experiment will examine the impact of cerebellar stimulation on brain activation during the performance of both sequence-demanding and non-sequence-demanding tasks.

Conduct disorder (CD) is one of the most prevalent childhood psychiatric disorders. Unfortunately, there are limited treatments available for CD. The present study aims to test an innovative virtual reality intervention called Impact VR for symptom reduction in a sample of 60 youth with CD.

In a neuroimaging session, study participants will repeatedly and intermittently report the content of their ongoing, self-generated experiences based on an experience-sampling protocol in which self-report ratings will be triggered based on real-time analysis of the participant's current brain state. The protocol will be conducted while participants are undergoing MRI scanning.

The purpose of the proposed study is to identify effective strategies for implementing lesbian, gay, bisexual, transgender, and queer (LGBTQ)- affirmative Cognitive-Behavioral Therapy (CBT) at LGBTQ community centers across the United States.

The overall aim of the proposed study is to determine the feasibility, acceptability, fidelity, and preliminary effectiveness of the adapted nurse-led, community-based rehabilitation treatment model for community-dwelling individuals living with psychosis in Blantyre, Malawi using a pilot randomized controlled trial.

This study seeks to adapt and pilot test a comprehensive wellness program to address the barriers to engagement in the HIV care continuum among men who have sex with men (MSM) and transgender women (TGW) in India. The content involves an adaptation of the earlier Chetana wellness adherence intervention which was found to successfully improve adherence and viral suppression among mainstream Indian persons living with HIV (PLWH). Based on the initial formative work, the adaptation includes added wellness group content and will be offered in a flexible format. It also uses peer navigators (PN), rather than Master-level counselors, to deliver tailored support at mutually convenient times and places. This PN model has been used successfully by Indian collaborators and in previous research in South Africa to link and retain PLWH in care. The intervention is intended to break the link between stigma and care seeking, which is especially important for key populations (KPs), who must deal with historically hostile legal environments and substantial isolation that further reduces engagement in HIV preventive practices and services .

Investigators are conducting this research to address the following aims:

1) To engage community stakeholders in the adaptation and pilot testing of the Chetana-PN wellness adherence intervention for use with Indian MSM and TGW who are living with HIV and who are newly or insufficiently engaged in care.

2a) To assess in a small randomized control trial (RCT) the acceptability and feasibility of the theoretically-guided, adapted intervention and to obtain preliminary effect size estimations for the impact of the intervention on engagement in care, among MSM and TGW.

2b) To characterize participant and navigator experiences in the Chetana-PN intervention and describe the practices that were most successful at overcoming barriers to care with 25 participants who received the Chetana-PN intervention and the peer navigators. These findings will subsequently be used to inform a future RCT designed to establish the efficacy of this adapted Chetana-PN intervention for sexual minorities in India.

Deficits in executive functioning (EF) disproportionately impact children living in poverty and increase risk for psychopathology, particularly disruptive behavior disorders. This randomized clinical trial seeks to determine whether childhood EF, assessed across neural and behavioral units of analysis, is an experimental therapeutic target that can be directly modified through caregiver participation in the Chicago Parent Program (CPP), if increases in EF predict reduced disruptive behavior trajectories in low-income children over a short-term follow-up period, and identify which CPP-driven parenting skill improvements are the most influential in modifying EF. This work will contribute new knowledge as to whether a cost-efficient parenting intervention, developed for and with low-income families raising young children in poverty, can modify EF, a neural behavioral mechanism implicated in risk for childhood disruptive behavior problems.

Healthy adult subjects will participate in two sessions. The first session will involve measurements of brain activity using simultaneous recordings with electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI). During brain activity measurement, participants will perform cognitive tasks assessing attention. The second will involve fMRI-based neurofeedback during simultaneous EEG-fMRI recording. Participants will receive real-time visual feedback of signals measured from specific parts of their brain and will try to control that activity.

The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a single dose of pretomanid, added to an optimized background tuberculosis treatment regimen (OBR), in children with rifampicin-resistant tuberculosis (RR-TB) with or without human immunodeficiency virus (HIV).

The purpose of this study is to assess the feasibility of conducting a randomized controlled efficacy trial comparing the delivery of exposure therapy via a telemedicine-based virtual reality clinic (Doxy.me VR) vs. standard telemental health (TMH) to adults with intense fear of dogs, snakes, and/or spiders. The secondary purpose is to preliminarily examine the efficacy of using Doxy.me VR vs. TMH in reducing phobia severity.

Study participants will take part in one of the two types of treatments aimed at improving daily functioning as follows: either a Cognitive Training (CT) Program or an Enhanced - Treatment as Usual (E-TAU) Group. All group treatments will be provided at Razi Hospital and one of the sessions will be conducted at home. The Cognitive (thinking skills) Training and Neuropsychological Education Approach to Remediation (CT-NEAR) is a form of cognitive (thinking skills) training that consists of computer-game like brain exercises, learning about thinking skills strategies, and a "bridging group" to help participants use what is learned in daily life. Cognitive exercises are generally fun and playful and are done on a computer. The aim is to train thinking skills and ability to function better in daily life such as at school, university, or at work, or with friends and family. The program lasts 12 weeks with two weekly sessions in groups of 3 to 4 participants. Each session is 1½ hours in length and one of the sessions is which lasts 30 minutes is conducted at home using a tablet that will be provided by the study investigators.

The purpose of this research study is to understand how healthy individuals self-regulate motivation by observing brain activity using magnetic resonance imaging (MRI).

This project proposes to improve successful mental health service linkage in Child Welfare Services (CWS) by adapting and testing the After Action Review (AAR) team effectiveness intervention to augment the Child Family Team (CFT) services intervention. Despite being both required and a collaborative approach to service planning, CFT meetings are implemented with questionable fidelity and consistency, rarely including children and families as intended. By inclusion of child and family voice, the AAR-enhanced CFT should lead to increased fidelity to the CFT intervention and greater levels of parental satisfaction with the service and shared decision-making, thus resulting in enhanced follow-through with Action Plans and linkage to mental health care for children.

Background:

Negative emotional states can affect a person s behavior as they make decisions. For example, hunger may make people more impatient; they may then make riskier choices. Other negative emotional states that can change behavior include stress, pain, and sadness. By learning more about how emotions affect thinking and behavior in healthy people, researchers hope to better understand how to identify and treat people with mental disorders.

Objective:

To learn how negative emotions affect the brain and decision-making behavior.

Eligibility:

Healthy people aged 18 to 55 years.

Design:

Participants will have 3 clinic visits in 3 weeks.

Participants will fill out questionnaires. They will be asked about their personal history, their personality, and state of mind.

For 2 visits, participants will be assigned to different groups. Each group will experience 1 type of emotional stressor:

Some participants will watch a video.

Some will have to do arithmetic problems.

Some will have heat applied to an arm or leg.

Some will experience cold by immersing their hand in ice water.

For a snack craving test, some will be tempted by food after a 4-hour fast.

During these tests, participants will have sensors attached to their bodies. They will be videotaped. Saliva samples will be collected.

After the stressors, participants will do tasks on a computer. They will need to make choices.

Some participants will perform these decision-making tasks while lying in a brain scanner for functional magnetic resonance imaging. The brain scan involves lying on a table that slides into a cylinder that takes images of the brain.

...

This study aims to evaluate the feasibility and effectiveness of telehealth interventions for individuals at clinical high risk for psychosis (CHR). Psychosis typically emerges during late adolescence or early adulthood, significantly impacting long-term functioning. While CHR programs have the potential to reduce illness severity, individuals often face barriers such as stigma and limited access to services. Telehealth interventions could address these barriers and improve treatment accessibility and engagement. The study will focus on Group and Family-Based Cognitive Behavioral Therapy, Family-Based CBT, and individual CBT, adapted for telehealth delivery (GF-CBT-TH, F-CBT-TH, and I-CBT-TH). Participants aged 14-25 who meet CHR criteria will be randomly assigned to one of these interventions. Feasibility will be measured by recruitment rate, attendance, and retention. The study will assess the impact of the interventions on cognitive biases, social connectedness, family emotional climate, and proficiency in CBT skills. The three intervention groups will be compared in terms of psychosocial functioning, symptom severity, rates of remission from CHR, and rates of transition to psychosis. Additionally, factors like patient treatment preference, family emotional climate, and sociodemographic factors will be explored as potential moderators of treatment outcomes. Qualitative interviews will be conducted with participants and clinicians to inform dissemination efforts.

The proposed study research project aims to develop and test a mobile health intervention designed to improve the wellness of young people at risk for psychosis and facilitate users' engagement with treatment and thus reduce duration of untreated psychosis. This clinical trial will involve a remote pilot randomized controlled trial that will examine (1) the feasibility of the proposed research approach, (2) the acceptability and usability of the NORTH intervention as well as (3) the specific additive value of help-seeking support in the context of self-guided mHealth for early psychosis. The full intervention, which includes psychoeducational lessons, Cognitive-Behavior Therapy-based practices, a symptom tracking feature, and help-seeking resources will be compared to a "Lite" version that will include the lessons, practices, and tracking but exclude the help-seeking resources.

The study is being conducted to validate the feasibility of remote assessment of Tardive Dyskinesia.

Chronic sleep restriction is ubiquitous in both the general population and the military. The deleterious effects of sleep loss on human alertness and cognitive performance have been documented in numerous studies dating back to the nineteenth century. Over the past decade, evidence has emerged indicating that chronic sleep restriction may also precipitate deleterious, long lasting neuropathological changes in the brain. The purpose of this study is to determine neuropathological effects of sleep restriction and identify physiological mechanisms that correlate with sleep loss-induced performance impairment.

The objective of this study is to examine the effect of transcranial magnetic stimulation (TMS) on the prefrontal cortex and posterior parietal cortex.

This study will examine a new implementation strategy for the Youth Readiness Intervention (YRI), an evidence-based mental health intervention. The strategy will (a) leverage a delivery setting (schools) and workforce (teachers) used effectively in low- and middle- income countries; and (b) innovate with technology and mHealth tools to enhance mental health service delivery quality. The YRI will be implemented as an extracurricular resilience-building after school activity in Sierra Leone. Teachers will deliver the YRI and receive either mobile phone-supported supervision or standard in-person supervision. Mobile-based supervision will integrate WhatsApp, a free cross-platform messaging and voice service used widely throughout Africa, with mHealth digital tools. The mHealth tools will support supervision through key features, including voice activated content, fillable forms (i.e., YRI fidelity checklist), and visual dashboards to monitor fidelity. A hybrid type 3 implementation-effectiveness design will allow for evaluation of both mobile phone-based supervision as a new implementation strategy, and clinical effectiveness of the YRI on youth mental and behavioral health as secondary outcomes.

The majority of children exposed to early adversity and trauma do not have access to sustainably delivered evidence-based mental health programs (EBPs), despite the growing prevalence of large-scale multiple-EBP implementation efforts aimed at increasing access to these services. The objective of this proposal is to develop and test a package of implementation strategies designed to promote the sustained delivery of child trauma EBPs by reducing provider turnover through targeting the associated mechanisms of provider burnout and organizational psychological safety climate. Findings will have a significant public health impact by informing efforts to increase the sustained availability of child trauma EBPs, thereby improving outcomes for children exposed to trauma.

Building upon formative research, this mixed methods study will be conducted in three phases to develop, refine, and pilot-test a multi-component Family Peer Navigator model designed to increase access to and initial engagement in coordinated specialty care for early psychosis among Black/African American families.

Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities.

This is a clinical trial where adolescents aged 10-16 years old with Tourette Syndrome (or chronic tic disorder) are randomized to receive either real-time functional magnetic resonance imaging (fMRI) neurofeedback targeting the supplementary motor area (for the experimental intervention) or real-time fMRI neurofeedback (NF) from a control region (for the control intervention).

This study will visit 4 community mental health clinics in Washington state and work with clinic staff to find out if staff are regularly evaluating clinical outcomes using questionnaires (which is also called measurement-based care). The study team will partner with clinic staff to find out what makes using questionnaires difficult and then plan to improve the use of questionnaires. The study activities will include trainings, interviews, collaborative discussions, and interactive activities.

The goal of this experimental medicine clinical trial is to test the hypothesis that nitrous oxide inhalation will result in a change in neurocircuit function in healthy controls and in individuals with impulsive aggressive tendencies. The main question aims to answer are: Does Nitrous Oxide normalize brain circuit function in impulsively aggressive individuals 24 hours after inhalation. Participants will undergo a 60 minute inhalation session with 50% Nitrous Oxide (or room air at another session) and then undergo an fMRI scan 24 hours later. Researchers will compare healthy controls and impulsively aggressive individuals to see if Nitrous Oxide can normalize the function of cortico-limbic circuits in the latter group.

Healthcare providers' implicit bias has been identified as a contributor to longstanding health inequities via negative impacts on the patient-clinician relationship and biased delivery of high-quality evidence-based practices (EBP). The implementation of any EBP runs the risk of worsening existing health disparities due to inequitable access, delivery, or benefit of the intervention. Clinician bias can be a critical and unaddressed determinant of implementation for any EBP. Although some implicit bias interventions for healthcare providers are emerging, studies have rarely included mental health professionals. In a previously NIMH funded project, our research team iteratively developed a brief (\~45 minutes), interactive online Virtual Implicit Bias Reduction and Neutralization Training (VIBRANT) for school mental health clinicians with promising preliminary findings. The current study will test the effectiveness of VIBRANT-an implementation strategy for promoting equitable adoption, penetration, fidelity, and sustainment of EBPs. One highly learnable, efficient, and scalable EBP that is particularly well-suited for the education sector is Measurement-Base Care (MBC)-the systematic collection of patient-reported progress data to inform clinical decision-making. The proposed study aims to (1) evaluate VIBRANT's feasibility to promote equitable adoption, penetration, fidelity, and sustainment of MBC, with a validated, brief, interactive online training for MBC; (2) examine VIBRANT's impact on proximal mechanisms of change including clinicians' implicit bias as well as distal youth mental health outcomes (i.e., symptoms and functioning) with Black and Latinx youth, and (3) assess feasibility of research procedures for a future large-scale efficacy trial.

This project engages community mental health center (CMHC) clinical supervisors in the development and examination of an optimized coaching strategy for psychotherapists utilizing Cognitive Behavioral Therapy (CBT) in Washington State. The optimized coaching strategy has the potential to enhance the adoption and fidelity of evidence-based practice (EBP).

The objective of this study is to examine the effect of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting the reward circuit.

Studies show that hormones affect the brain's fear extinction network, which is relevant for therapy involving exposure and response prevention (EX/RP), a first-line treatment for obsessive compulsive disorder (OCD). This study will examine the effect of delivering EX/RP to women during different phases in their menstrual cycle to determine the effects of hormones on the fear extinction network and on their OCD symptoms.

Women in the menopause transition (perimenopause) experience substantial day-to-day variability in estradiol and have a 2-4-fold increase in major depression risk. About 40% of perimenopausal women are susceptible to the emergence of affective symptoms tied to changes in estradiol. Among the perimenopausal women with affective impairment, most report irritability, not "depression," is their primary source of impairment and distress. The purpose of this research is to determine the neurophysiologic basis of susceptibility to estradiol fluctuations and irritability symptoms in perimenopausal women.

The study will examine the mechanisms by which Economic Empowerment (EE) and Family Strengthening (FS) interventions targeting social, familial and context-specific drivers affect childhood behavioral health (CBH). The study will randomly assign 900 children in mid-upper primary school (10 to 14 years) to one of the three study arms (10 schools each): 1) EE only (n=300), 2) Multiple Family Group (MFG)-based FS only (n=300), and 3) combined EE+MFG-based FS (n=300). The interventions will be provided for 12 months. Assessments will occur at baseline, 12, 24 and 36 months.

The Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) is a large international collaboration to develop algorithms using a set of clinical and cognitive assessments, multi-modal biomarkers, and clinical endpoints that can be used to predict the trajectories and outcomes of individuals at clinical high risk (CHR) for psychosis and to advance the testing of pharmacological interventions for CHR individuals in need. The goal is to accurately predict which individuals are likely to remit, experience an acute psychotic episode, or have intermediate outcomes that feature persistent attenuated psychotic and/or mood symptoms along with functional impairment. The prediction algorithms will have the potential to serve as early indicators of treatment efficacy in CHR persons.

The AMP SCZ research program is made up of the Psychosis Risk Evaluation, Data Integration, and Computational Technologies - Data Processing, Analysis and Coordination Center (PREDICT-DPACC) and two clinical research networks, the Psychosis-Risk Outcomes Network (ProNET) and the Trajectories and Predictors in the Clinical High Risk for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT) networks. The two clinical research networks will recruit a large cohort of CHR young people aged 12-30 years (n=1,977) and healthy control (HC) participants (n=640) across 42 participating investigative sites from 13 countries. CHR participants will complete screening, baseline assessments and a battery of follow-up assessments across 18 - 24 months. HC participants will complete screening and baseline assessments and a subset (5 per site) will complete month 2, 12 and 24 visits.

Background:

Brain activity produces magnetic fields. These fields can be measured outside the head. Existing technology, called MEG, measures these fields. Researchers are testing a new type of magnetic field sensor called OPM. They hope it can help pinpoint with very high accuracy where brain activity is generated.

Objective:

To develop and test a new type of sensor for measuring the magnetic fields produced by brain activity.

Eligibility:

Healthy people ages 18-65 who had a magnetic resonance imaging (MRI) scan under protocol 17-M-0181.

Design:

Participants may be asked to complete sessions on both the traditional MEG instrument and the OPM array.

For the MEG, 3 small coils will be placed on the participant s face with tape. Their head will be positioned inside the MEG device.

For the OPM, sensors are housed in a 3d printed array. The sensors will be attached to a cap placed on the participant s head.

For both scans, participants will be seated in a chair inside a magnetically shielded room. They may complete several tasks. In one task, plastic cells will be placed on their fingers. Puffs of air will be sent to these cells, which will stimulate the sense of touch. Other tasks may include the following stimuli: visual (such as checkerboards), auditory (such as beeps and tones), or language (words and letters).

Researchers may also obtain recordings while they stimulate the nerve in the participant s forearm using electrical current in small electrodes.

Participation is expected to last for 1 day. Additional optional scans may be offered for up to 1 year....

The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.

The purpose of this study is to test the effectiveness of a multicomponent implementation strategy entitled the Systems Analysis and Improvement Approach for mental health (SAIA-M) using a cluster randomized trial at the health facility level. SAIA-MH focuses on improving the mental health treatment cascade in primary outpatient mental healthcare. The mental health treatment cascade is a model that outlines the sequential, linked treatment steps that people with mental illness must navigate, from initial diagnosis to symptom/function improvement.

This study will also assess the potential mechanisms by which the SAIA-MH implementation strategy works, or does not work, along with the cost and effectiveness of scaling-up SAIA-MH in Mozambique.

This 4-year study will randomize 1,000 people with co-occurring opioid use and mental health disorders (COD) at medication for opioid use disorder (MOUD) clinics to evaluate the effectiveness of MISSION, a multi-component team approach, or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or its components for improving outcomes. We expect that individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: engagement, substance use, and mental health.

This study will compare a 12-session behavioral activation (BA) intervention modified for first-episode psychosis (FEP) to usual community mental health care (i.e., treatment-as-usual; TAU) delivered over 6 months with a sample of Latinos with FEP and their families. Comparable family group sessions will also be delivered to participants in both conditions. It is expected that BA participants will show better engagement than TAU participants.

Adverse Childhood Experiences (ACEs) are pervasive among children with 45% experiencing at least one ACE and 10% experiencing three or more, placing them at high risk for toxic stress and symptomatology. Yet, ACEs often go undetected in primary care settings during well-child visits due to unclear policies and tested implementation strategies. This pilot study will use mapping methodology, guided by the Exploration, Preparation, Implementation and Sustainment (EPIS) framework, to refine a multi-faceted strategy supporting the implementation of the state of California's 2020 policy promoting universal ACE screening in community clinics, and a stepped-wedge trial to test the impact of the strategy on implementation and child-level outcomes.

This study aims to develop an ethical approach to developing and deploying novel neurotechnologies to aid in the detection of consciousness and prediction of recovery after brain injury.

The participants will perform a cognitive control task. During the task, rhythmic trains of transcranial magnetic stimulation will be delivered to the prefrontal cortex and parietal cortex. Participants will be screened for their ability to perform the task. Magnetic resonance imaging will be used to localize regions of interest to be targeted. Electroencephalography will be collected concurrent with stimulation.

The proposed research project provides a novel approach to screening, early assessment, and preventive interventions for high-risk youth in racial/ethnic/linguistically (REL)-diverse communities.

* The investigators assess a health promotion intervention as a way of reducing treatment disparities in REL-minority youth. This population is underrepresented in child psychiatry research. It is often excluded from clinical trials of medication or therapy because of challenges with transportation, literacy, resources, or other issues. * The study will take place during or following a healthcare crisis and economic recession, making findings relevant to understanding the mechanisms by which hardship translates into youth mental illness. * The innovative integration of online screening into school-based clinics and community-based settings in REL-minority communities is made possible by the combination of access to a new technology (CAT) in the context of a learning health community serving a REL-minority population. * Empirical research on the impact of a resilience-based prevention intervention in youth and youth at risk is both innovative and much needed during this period of health, social and economic crisis.

For caregivers in the Bronx, the pandemic has caused unprecedented psychological distress; in addition to combating social determinants of health (SDOH), these families now face greater financial insecurity and challenges related to their school-aged children. Furthermore, social distancing requirements and limited telehealth resources for Bronx families have posed greater barriers to healthcare. Such parental distress contributes to heightened risk of transgenerational cycles of psychological stress, trauma and maltreatment. The social and economic impacts of the COVID-19 pandemic have had significant consequences for family well-being, putting parents at higher risk of experiencing distress and potentially impairing their ability to provide supportive care to their children. Although children may be less susceptible to the most damaging physical consequences of COVID-19, there are growing concerns regarding the short-and long-term impacts of pandemic-related stressors on children. The marked upheaval of family life over an extended period may make children vulnerable to mental health consequences associated with the public health crisis and infection mitigation efforts. School and childcare closures, unstable financial circumstances, social isolation and lack of support have a disproportionate, cumulative impact on parents and may undermine their capacities to provide support for their children. Importantly, a large body of evidence suggests that parental stress during times of disasters induces psychopathologies in family members including children. Further, high anxiety and depressive symptoms in parents during the pandemic have been associated with higher child abuse potential, whereas greater parental support was associated with lower perceived stress and child abuse potential. In addition to psychological impacts, stress associated with caregiving can interfere with parents' ability to maintain their own health. This multimodal study addresses key strategies to mitigate the psychological and health impact of COVID-19 in parents.

Background:

During the first few decades of life, the brain changes dramatically in shape and function. Sleep lets researchers measure these changes. Researchers want to create a database of sleep and neurodevelopmental data in a group of infants and children to learn more.

Objective:

To address a knowledge and data gap in the field of sleep and neurodevelopment in infants and children.

Eligibility:

Children ages 6 months to 76 months who may or may not be at risk for neurodevelopmental and neuropsychiatric disorders. Also, children ages 6 months to 8 years who have a referral for a sleep study.

Design:

Participants will have neurodevelopmental testing. They will have a medical, psychiatric, and family history. They will have a physical and neurological exam. They will be interviewed and complete surveys. They will give a cheek swab and/or blood sample.

Some participants will have 1 study visit that lasts 2 days.

Other participants will have up to 4 study visits. Each visit will last 2 days. Visits occur every 8 months to 1 year, for a total participation time of 2 years.

Participants will have a 20-minute daytime electroencephalogram (EEG), if possible. This EEG session will be used to calibrate the machine for the overnight study.

Participants will take part in an inpatient overnight sleep study. Electrodes will be placed on the participants. For young children, parents will help place the EEG leads. Other sensors may also be placed. A gauze cap will be placed on participants head to protect the leads and keep the participants from moving them. 'Lights out' will occur as close to participants bedtime as possible.

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The purpose of this study is to assess sense of control and catastrophic symptom expectations as targets for Retraining and Control Therapy (ReACT- an intervention focused on changing behaviors and thoughts) for treatment of pediatric psychogenic non-epileptic seizures (PNES, episodes resembling epileptic seizures but with no medical explanation). 11-18-year-olds diagnosed with PNES will engage in twelve sessions of ReACT. Sense of control over actions will be measured by the magic and turbulence task, a well-validated measure of sense of control. Participants will complete the cold pressor test (CPT) in which participants hold their hand in cool water for as long as possible up to 3 minutes. Catastrophic symptom expectations in response to the CPT will be measured by Pain Catastrophizing Scale for Children (PCS-C) pain tolerance (time with hand in water) and cortisol response. Target assessments will occur 7 days before treatment, 7 days after 8th treatment session and 7 days after 12th treatment session. Participants will also complete long term follow-up visits via HIPAA-compliant Zoom at 6 months and 12 months after the 12th treatment session where participants will complete questionnaires. PNES frequency will be measured from 30 days before to 12 months after treatment.

The purpose of this study is to learn more about teachers' sustainment of use of core components of BEST in CLASS in a follow-up study.

The purpose of this study is to perform a practice-based research project designed to assess whether cognition and motivated behavior in early psychosis can be addressed as key treatment goals within real-world settings by using a 12-week mobile intervention program. Participants who are enrolled in a chart review study of measurement-based care will be recruited to participate in this study. In the measurement-based care study, participants are enrolled in coordinated specialty care programs for early psychosis that provide comprehensive clinical services such as psychotherapy, medication management, psychoeducation, work or education support, and measurement-based care. Participants will complete a set of well-defined measures every 6 months that assess symptoms, functioning, cognition and motivation as standard of care. The current study will utilize the data acquired in the measurement-based care study.

The aim of this study is to investigate a well-defined 12-week mobile intervention program specifically designed to target cognitive functioning and motivated behavior for individuals with early psychosis. The investigators will test for differences in the clinical trajectories over 18 months in those who receive the intervention vs. those who do not.

This study will be conducted jointly with a sister protocol under a separate NCT listing. This iteration will be conducted locally within the EPI-MINN Network, while the other project will be conducted on a national scale.

This phase I trial studies if positron emission tomography (PET) imaging using 11C-YJH08 can be useful for detecting certain cell receptor expression in tumor cells in patients with cancer that has spread to other parts of the body (metastatic). 11C-YJH08 is a small-molecule radiotracer that binds to receptors on cells (glucocorticoid receptor) so that they show up better on the PET scan. Systemic therapy (including enzalutamide) can cause more glucocorticoid receptors to be produced in tumor cells, which can make the tumor cells resist hormone therapies. If researchers can find a better way to detect whether glucocorticoid receptors are increasing during therapy, it may lead to more successful therapies using glucocorticoid receptor antagonists.

Auditory hallucinations are among the most distressing aspects of psychotic illness, and between 10 and 30% of people with hallucinations do not respond to antipsychotic medications. The authors have used computational modeling of behavior to link brain activity to development of auditory hallucinations in the hope of guiding new treatment development. The proposed studies take the first step toward individualized treatment approaches to hallucinations by attempting causal, pharmacological manipulation of relevant model parameters underlying these phenomena.

Access to effective pediatric mental health treatment is a major public health concern in the United States as paucity of pediatric providers leading to long wait times, financial burden, and stigma pose significant barriers to treatment. Digital mental health promises to remedy many chronic problems faced in providing timely and accessible mental health interventions to children. With that in mind, the investigators and Neuromotion Inc. created Mightier, an app-based heart rate biofeedback videogame platform designed to teach and facilitate practice of emotional regulation skills. The technology behind Mightier is backed by three trials showing clinical efficacy and since commercial launch 75% of families who have engaged with the product report improvement. However, Neuromotion's core mission remains increasing access to care, and the direct-to-consumer distribution of digital health also faces access challenges. The investigators propose that access to effective digital mental health interventions can be increased by meeting families where they already know to seek care: the traditional healthcare system. The investigators have partnered with a nationwide behavioral health insurance provider to pilot the integration of Mightier with traditional healthcare. Families will be recruited via direct outreach, social media, or healthcare provider referral. Participating children will be randomized into Mightier or treatment as usual control groups for 6 months. Behavioral healthcare utilization will be observed for 12 months. Through this work the investigators will demonstrate the value of Mightier to various stakeholders via decreased long-term healthcare utilization, confirm that Mightier use results in decreased symptoms of emotional dysregulation, irritability, and parent stress, and explore relationships among Mightier use, healthcare utilization, and symptoms. Ultimately this work will pave the way forward for large scale integration of digital healthcare and more traditional healthcare avenues while simultaneously increasing Mightier's ability to reach children in need.

A core symptom of body dysmorphic disorder (BDD) is perceptual distortions for appearance, which contributes to poor insight and delusionality, limits engagement in treatment, and puts individuals at risk for relapse. Results from this study will provide a comprehensive mechanistic model of brain, behavioral, and emotional contributors to abnormal perceptual processing, as well as how malleable it is with visual modulation techniques. This will lay the groundwork for next-step translational perceptual retraining approaches.

This study is examining the efficacy and mechanism of family therapy compared to usual care for children between the ages of 6 and 12 who are diagnosed with Avoidant/Restrictive Food Intake Disorder. Preliminary data suggest that family therapy is superior to usual care and that improvement in parental self-efficacy related to feeding their children is the mechanism of treatment. In addition, this study will attempt to identify specific patient groups who respond to family therapy.

The aims of this project is to use an artificial intelligence (AI) smartphone app to provide support for medication adherence by patients with first episode psychosis.

This project will assess the feasibility of traveling wave transcranial alternating current stimulation (tACS) to modify working memory performance and large-scale brain connectivity in surgical epilepsy patients.

Maintaining treatment engagement is critical for first episode psychosis patients to experience gains possible with coordinated specialty care (CSC). This study is designed to identify CSC participants still receiving care but at high risk for disengagement and to intervene to prevent/delay disengagement.

Background:

Inflammation can play a role in diseases like heart disease and rheumatoid arthritis. PET scans can help detect inflammation. Two new drugs may create better PET images.

Objective:

To see if the drugs \[11C\]ER176 and \[11C\]MC1 can help image inflammation.

Eligibility:

People ages 18 and older with rheumatoid arthritis or idiopathic inflammatory myopathy (IIM).

Healthy volunteers enrolled in protocol 01-M-0254 or 17-M-0181 are also needed.

Design:

Healthy participants will be screened under protocol 01-M-0254 or 17-M-0181.

Participants with arthritis or IIM will have a screening visit. This will include:

Medical history

Physical exam

Blood and urine tests

Possible CT or X-ray: A machine will take pictures of the body.

Healthy participants will have 1 or 2 visits. They may have urine tests. They may take the drug celecoxib by mouth. They will have a PET scan. A small amount of one or both study drugs will be injected through a catheter: A needle will guide a thin plastic tube into an arm vein. Another catheter will draw blood. They will like on a bed that slides into a machine. Their vital signs and heart activity will be measured.

Participants with arthritis will have up to 2 visits after screening. They may take celecoxib and have PET scans.

Participants with IIM will have up to 3 visits after screening. At 1 or 2 visits, they will take celecoxib and have PET scans. They will have 1 visit where they have an MRI: They will lie on a table that slides into a machine. The machine takes pictures of the body.

The purpose of this study is to test the USE-MI system hardware and software to see if it can accurately measure when subjects take their HIV-related medications and help them remember to take these medications. With the use of a smartwatch and smartphone "app", investigators hope to be able to monitor medication adherence in real-time and send subjects electronic reminders when they may have forgotten to take their medication.

The goal of this proposal is to understand the common and distinct behavioral and neural representations of subjective effort valuation, and how these representations are influenced by fatigue and changes in motivation. It is hypothesized that the brain will use overlapping and distinct neural circuits to represent cognitive and physical effort value, and that fatigue and enhanced motivation will influence the subjective value of effort.

Background:

Magnetic resonance imaging (MRI) is an important non-invasive tool to study and diagnose cardiovascular disease. MRI scanners use strong magnetic fields and radio waves to create pictures of body organs. Researchers want to find better MRI methods and new ways of imaging cardiovascular disease and better understand normal and abnormal cardiovascular and brain function. Researchers are also interested in seeing if gadolinium, the commonly used MRI contrast agent, stays in the body long after the MRI was performed.

Objectives:

To develop new methods for imaging the heart and other organs of the body.

To describe cardiovascular diseases using newer MRI methods

To look at the relationship between cardiovascular disease and cardiovascular risk factors and other organ systems

To look for gadolinium deposits in the brain from prior exams.

Eligibility:

Healthy people and people with known or suspected cardiovascular disease ages 7 and older may be eligible for this study.

Researchers may be particularly interested in those who:

* Have suspected or known cardiovascular disease * Were previously exposed to a gadolinium-based contrast agent, * Need to have a heart MRI scheduled * Need a test of the heart or other body part or will be undergoing a future cardiac catheterization

Design:

There are multiple arms to the study with optional components; therefore, there are multiple variations as to what an individual participant s experience may involve.

Participants will have an MRI scan lasting up to 2 hours. The scanner is a large hollow tube. During the scan, there may be loud knocking and buzzing sounds caused by the scanner. Participants will lie on a table that slides in and out of the tube. Their vital signs may be monitored.

Participants may have a test of heart electrical activity using wires connected to pads on the skin.

Participants may have blood drawn.

Participants may be injected with an MRI contrast agent through a plastic tube inserted in the arm.

Background:

Noninvasive brain stimulation (NIBS) may help diagnose and treat psychiatric and neurological illness. But there is not enough research on how to apply NIBS. This includes how strong to make it, where on the brain to apply it, and for how long. Researchers also want to see what the brain is doing when it receives NIBS.

Objective:

To increase the effectiveness of NIBS.

Eligibility:

Healthy native English speakers ages 18-65

Design:

Participants will be screened under another protocol with:

Medical and psychiatric history

Psychiatric evaluation

Physical exam

Urine tests

All participants will start with a 2-hour visit for screening. (see below). They may learn how to do tasks that will be used later. After the screening session, they will be scheduled for an MRI session.

The next part of the study is 4 substudies. Each substudy includes up to 4 sessions. A session is usually 2-3 hours but can last up to 8 hours. Participants can join multiple substudies, but only 1 at a time. They can do only 1 session on a given day.

Each substudy includes the following:

Behavioral tests: Interviews; questionnaires; simple tasks; and tests of memory, attention, and thinking

Electromyography: Small sticky electrodes on the skin measure muscle activity.

Transcranial magnetic stimulation: A wire coil is held to the scalp. A brief electrical current passes through the coil and affects brain activity.

Magnetic resonance imaging (MRI): Participants lie on a table that slides into a machine that takes pictures of the brain. A coil is placed over the head. They will perform simple tasks while in the scanner. They may also get TMS.

Electroencephalography: Small electrodes on the scalp record brain waves.

Sponsoring Institution: National Institute of M

Objective: To screen and create a list of adult volunteers in good health for participation in research studies conducted at the National Institutes of Health (NIH) in Bethesda, Maryland. Develop a normative set of structural and functional brain MRI scans that are linked to healthy research volunteer characteristics. Maximize scientific impact of data from volunteers by broadly sharing with other researchers.

Study Population: Adult males and females in general good health who are 18 years of age and older.

Design: Adult individuals who are interested in participating in NIMH IRP clinical studies as a healthy research volunteer can directly visit or be directed to visit the study website where they will first consent electronically and then complete a set of online self-report measures. Items may include: demographic information, mental health symptoms, disability status, substance use patterns, handedness and clinical/family history. Individuals who are flagged based on predetermined responses to survey items will be further screened by a member of the study clinical team. If found to be ineligible for the study because of a clinically significant or unstable medical or mental health condition, these individuals will be referred back to the community and/or given information about NIMH clinical studies for which they may be eligible. Respondents with no flags or who pass through additional screening will be scheduled for an in-person assessment. During the outpatient appointment and after in-person informed consent, participants will receive a brief clinical interview to screen for current medical and mental conditions, and risk for self-harm. They will complete assessments of psychological, emotional, physiologic, biological and cognitive functioning. Participants will undergo a physical exam and be asked to provide blood and urine samples for routine clinical labs as well as additional blood samples for future secondary analysis that could include genetic or biomarker assays. Participants can separately consent for an optional baseline brain magnetic resonance imaging (MRI) scan and an optional magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that if enrolled in the study, their de-identified data will be broadly and publicly shared through NIH-approved data repositories. Participants in this recruitment and characterization study will then be placed on a list of healthy research volunteers from which other NIMH IRP studies may recruit according to the inclusion and exclusion criteria in their respective IRB-approved protocols.

Outcome Measures: Outcome measures may include demographic data, mental and medical history and symptoms, results of psychological, emotional, physiologic, biological, and cognitive testing, physical exam and MRI findings.

...

Background:

Genetic testing called "sequencing" helps researchers look at DNA. Genes are made of DNA and are the instructions for our bodies to function. We all have thousands of genes. DNA variants are differences in genes between two people. We all have lots of variants. Most are harmless and some cause differences like blue or brown eyes. A few variants can cause health problems.

Objective:

To understand the genetics of immune disorders various health conditions, as well as outcomes of clinical genomics and genetic counseling services performed under this protocol.

Eligibility:

Participants in other NIH human subjects research protocols - either at the NIH Clinical Center (CC) or at Children s National Health System (CNHS) - (aged 0-99 years), and, in select cases, their biological relatives

Design:

Researchers will study participant s DNA extracted from blood, saliva, or another tissue sample, including previously collected samples we may have stored at the NIH. Researchers will look at participant s DNA in great detail. We are looking for differences in the DNA sequence or structure between participants and other people.

Participants will receive results that:

* Are important to their health * Have been confirmed in a clinical lab * Suggest that they could be at risk for serious disease that may affect your current or future medical management.

Some genetic information we return to participants may be of uncertain importance.

If genetic test results are unrelated to the participant s NIH evaluations, then we will not typically report:

* Normal variants * Information about progressive, fatal conditions that have no effective treatment * Carrier status (conditions you don t have but could pass on)

The samples and data will be saved for future research.

Personal data will be kept as private as possible.

If future studies need new information, participants may be contacted.

Sub-Study: Phase Triggered Paired Associative Stimulation (PAS) (actively recruiting)

Background:

-Previous research has shown that the brain s activity changes with changes in brain waves. We can study brain activity with a procedure called transcranial magnetic stimulation (TMS), a form of non-invasive brain stimulation. EEG allows for measuring ongoing brain waves. The goal of this study is to optimize TMS delivery by utilizing EEG-triggered TMS.

Objectives:

-To see if changes in brain waves change the brain and body s response to TMS.

Eligibility:

-Healthy, right-handed adults age 18-35.

Design:

* Participants will be screened under another protocol with medical history and physical exam. They may take a pregnancy test. They will have a magnetic resonance imaging (MRI) scan of the brain. For MRI, participants lie on a table that slides in and out of a metal tube that takes pictures. with: * Participants will have up to 4 outpatient visits lasting 2-3 hours each (4 outpatient visits). The following procedures may occur at a visit: * Magnetic resonance imaging (MRI): Participants lie on a table that slides into a machine that takes pictures of the brain. * Electroencephalography (EEG): Small electrodes on the scalp record brain waves. * Electromyography (EMG): Small sticky electrodes on the skin measure muscle activity. * Transcranial magnetic stimulation (TMS): A wire coil is held to the scalp. A brief electrical current passes through the coil and affects brain activity.

Main Study: Influence on Plasticity of Brain Temperature (no longer recruiting)

Background:

- Brain activity changes with changes in body temperature. Brain activity can be studied with a procedure called transcranial magnetic stimulation (TMS). Researchers want to cool the brain through the scalp using a cooling cap. They want to see if cooling changes the brain and body s response to TMS.

Objectives:

- To look at the effects of cooling on the brain.

Eligibility:

- Right-handed adults age 18-50 who can abstain from caffeine and tobacco.

Design:

* Participants will be screened with medical history and physical exam. They will be asked about alcohol use, smoking, and substance abuse. They may take a pregnancy test. They may have a magnetic resonance imaging (MRI) scan of the brain. For MRI, participants lie on a table that slides in and out of a metal tube that takes pictures. * Participants will have 3 outpatient visits. The following procedures will occur at each visit. * Participants will wear a cooling cap for up to 45 minutes. Cool water will flow through the cap. It will feel like an ice pack in a towel. Their core temperature will be monitored. Their temperature will also be measured under their tongue and on scalp, stomach, forearm, and calf. * Participants will have TMS before and after wearing the cap. A brief electrical current will pass through a wire coil held on their scalp. Electrodes that detect muscle movement will be placed on their hand. They will also have repetitive TMS, which uses repeated magnetic pulses. Their wrist will also receive a shock.

Background:

When children have severe irritability and temper outbursts, they can be so cranky or angry that it leads to problems at home, in school, and with friends. This is called Disruptive Mood Dysregulation Disorder (DMDD) and there have been no psychological treatments developed specifically for children with this problem. Researchers think two forms of therapy, Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT), might help children with DMDD.

Objective:

To test two whether IBT and CBT can decrease severe irritability in children and youth.

Eligibility:

Children 8-17 years old with DMDD. Their symptoms must have started before age 10.

Design:

Participants will be screened with a review of their symptoms. Parents and participants will answer questions.

Participants can do only one or both of these treatments if they wish. Those who wish to do both will start with IBT.

Participants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent will participate in part of the sessions.

Participants will talk about what makes them irritable and how it affects them. They may be put in situations that might make them annoyed or irritable.

Participants will rate how intense their irritability is. Parents and participants will complete rating scales, questionnaires, and interviews.

Participants will do practice activities at home.

Participants doing IBT will have up to 14 sessions over 10 weeks.

Participants will view 15 faces, one at a time, on a computer. They will choose if the face looks happy or angry on a computer. Sometimes the computer gives feedback. Participants will complete some sessions at the NIH and some at home.

Participants and parents answer questions about their progress.

...

Background:

-The brain has two systems for recognizing objects. One system recognizes what an object is, and the other system recognizes where the object is located. However, there is much about how the brain handles and interprets the information from these two systems that is still unclear. Researchers want to study the parts of the brain that are involved in how vision is processed. They will use magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS) or transcranial electrical stimulation (tES) on the brain. MRI measures what parts of the brain become more active when tasks are performed. TMS uses magnetic pulses to temporarily change the activity in parts of the brain. tES uses electrical current to temporarily change brain function.

Objectives:

-To better understand how people visually recognize different types of objects.

Eligibility:

-Healthy volunteers between 18 and 50 years of age, who only speak English.

Design:

* This study includes many different experiments on vision. Each experiment may combine visual tasks, MRI scans, and TMS or tES. Participants may be asked to have several different tests. Each test will require a separate visit to the National Institutes of Health. * Participants will be screened with a physical exam and medical history. They will have a baseline brain scan at the first visit. * Participants may do visual tasks alone, with MRI only, with TMS or tES only, or with MRI and TMS or tES combined. For the visual tasks, they will look at pictures of objects on a computer screen. Sometimes the images will appear very briefly (less than one-tenth of a second). Sometimes they will appear for up to 5 seconds. These images will be of things like faces, bodies, tools, and scenes. Participants will be asked to respond in different ways to the pictures. They may respond by typing on a computer keyboard or by pressing a button. Participants will have time to practice the tasks before the experiment. * Participants will remain on the study for up to 3 years.

Background:

- Previous studies have shown that people with certain types of brain damage may have particular problems paying attention and processing things that they see. Researchers are interested in comparing how people with brain damage and without brain damage process visual images.

Objectives:

- To better understand the areas of the brain involved in paying attention to things that are seen.

Eligibility:

- Individuals at least 18 years of age who either have had damage to one or both sides of specific parts of the brain (e.g., stroke, injury, certain neurosurgery procedures) or are healthy volunteers.

Design:

* The study involves 4 to 10 visits to the NIH Clinical Center over 1 to 2 years. Each visit will last approximately 2 hours. * Participants will be screened with a medical history and physical examination, and may have the cognitive testing described below during the same visit. * On the first visit and for at least one visit thereafter, participants will have cognitive testing to evaluate thinking and memory. These tests will be either written tests or computer-based tests. * Some participants will qualify for functional magnetic resonance imaging (fMRI) as part of the study. This part will involve a decision-making task that will be performed on a computer during the fMRI scan. Additional scans may be required as directed by the study doctors. * Some randomly selected participants will be asked to have magnetoencephalography (MEG), a procedure to record very small magnetic field changes produced by brain activity. * During the behavioral training, or fMRI or MEG scanning, participants may be monitored with equipment to track eye movements.

Despite the clear importance of adolescence in the emergence of a number of disease states and processes, there is surprisingly little known about how the endocrine and metabolic events accompanying puberty in humans impact normal developmental neurobiology. Epidemiologic studies have identified sexual dimorphisms in the prevalence of several neuropsychiatric disorders, including depression, schizophrenia, and substance abuse. Many of these sex differences emerge during or shortly after puberty and are maintained until the 5th-6th decade of life. For example, the two-fold greater risk of unipolar depression in women compared with men does not appear until adolescence, and prior to puberty girls are not at increased risk relative to boys. Puberty is a structured, transitional process that can be influenced by both nutritional factors and environmental stressors; nonetheless, the variability in the timing and duration of puberty is largely determined by oligogenic inheritance. Basic neuroscience research has demonstrated that hormonal events accompanying puberty impact on many of the physiologic systems involved in the regulation of brain function (e.g., the appearance of new neurons in a brain-region specific pattern, neuronal remodeling, and the pruning of cortical connectivity). Additionally, not only does stress during puberty increase the risk of disturbances in affective adaptation during adulthood, but the events accompanying puberty modify stress responsivity (e.g., alterations in the duration and peak response of hypothalamic-pituitary-adrenal \[HPA\] axis hormones to stressors). Moreover, animal work has demonstrated that neural connectivity differs in a brain regional specific manner according to the stage of puberty (i.e., early versus late). In humans, puberty also occurs in stages, and although the endocrinology of puberty, surprisingly, has not been fully characterized with longitudinal data, studies have documented that the physical changes measured by Tanner stages I to V are accompanied by progressive increases in the secretions of both gonadal and adrenal steroids. Nonetheless, there remains considerable variability in the timing and duration of this otherwise highly structured reproductive transition.

We propose to perform a longitudinal, naturalistic study examining changes in brain structure and function, behavior, and stress responsivity in boys and girls across the pubertal transition. Because the pubertal transition is defined by a complex series of physiologic events that emerge sequentially over several years and involve changes in multiple endocrine and growth systems, and because there is also considerable variability in the timing of these events reflecting the influence of both genetic and environmental factors, puberty cannot by delineated by age of the participants as has been done in most imaging and other neurobiological studies of adolescence. The present study will formally bridge this gap by defining pubertal events per se in participants.

Participants will include healthy boys and girls whose pubertal status will be assessed, and in whom endocrine, metabolic, and brain imaging measures will be evaluated at eight - ten month intervals from age eight years (pre-puberty) until age 17 years (post-puberty). Reproductive endocrine, metabolic, and physical measures will be employed to characterize the stage and duration of pubertal development. Outcome measures will be derived via multimodal neuroimaging techniques, cognitive/behavioral assessments, metabolic measurements, and evaluations of HPA axis function. Additionally, the impact of genetic variation on the developmental trajectory of these parameters (both reproductive and CNS) will be determined.

This cross-institute proposal will employ a multidisciplinary approach to evaluating the effects on CNS function of the process of puberty in both boys and girls. This work will not only serve to inform research on the mechanisms by which sexual dimorphisms in neuropsychiatric disorders develop, it will also have important implications for the prevention and treatment of these disorders.

...

Background:

- Magnetic resonance imaging (MRI) is a widely used scanning technique to obtain images of the human body and evaluate activity in the brain. A particular MRI method called magnetic resonance spectroscopy (MRS) can be used to study brain chemistry as well, which may help researchers who are studying new treatments for psychiatric illnesses. Researchers are interested in improving current MRI and MRS techniques, as well as developing new MRI and MRS techniques to view and measure brain chemicals and brain activity.

Objectives:

- To implement, develop, and optimize brain chemistry imaging techniques using magnetic resonance imaging and magnetic resonance spectroscopy.

Eligibility:

- Healthy individuals between 18 and 65 years of age.

Design:

* This study will involve a screening visit and a scanning visit at the National Institutes of Health Clinical Center. * Participants will be screened with a full medical and physical examination, blood and urine tests, and neurological testing. * During the second visit, participants will have an MRI scan of the brain. (Participants who have received an MRI within the past year will not need to have a second one; the images of the previous scan will be used for this study.) All participants will then have an MRS scan using the same scanning equipment.

Background:

- Little is known about how the brain changes during childhood and adolescence, how genes affect this process, or how the brains of people with 7q11.23 genetic variation change during this period. Researchers are interested in using magnetic resonance imaging to study how the brain changes in healthy children and children with 7q11.23 genetic variation, including Williams syndrome and 7q11.23 duplication syndrome.

Objectives:

- To study developmental changes in the brains of healthy children and children who have been diagnosed with Williams syndrome,7q11.23 duplication syndrome, or other 7q11.23 genetic variation.

Eligibility:

* Healthy children and adolescents between 5 and 17 years of age. * Children and adolescents between 5 and 17 years of age who have been diagnosed with Williams syndrome, 7q11.23 duplication syndrome, or have other 7q11.23 genetic variation.

Design:

* Participants will have a brief physical examination and tests of memory, attention, concentration, and thinking. Parents will be asked about their child s personality, behavior characteristics, and social interaction and communication skills. * Both participants and their parents may be asked to complete additional questionnaires or take various tests as required for the study. * Participants will have approximately 10 hours of magnetic resonance imaging (MRI) scanning, usually over 4 to 5 days, within a one month period. Some of these tests will require the participants to do specific tasks while inside the MRI scanner. * Participants will be asked to return to the National Institutes of Health clinical center to repeat these procedures every 2 years thereafter until age 18.

SMARTT will estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born of HIV-infected mothers.

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