Therapy approaches for irritability in youths: active treatments vs nonactive psychoeducation
Official title: Psychotherapy for Irritability in Youth: Comparing Active Treatment to Non-Active Psychoeducation Supportive Psychotherapy
Run by National Institutes of Health Clinical Center (CC) · NCT07640802 · Data updated 2026-11-12
This study tests whether active psychotherapies for irritability in kids aged 8–16.5 years work better than nonactive, time-matched psychoeducation for children and their parents.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 8 Years to 17 Years |
| Sex | All |
| Enrollment | 410 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | November 15, 2026 |
| Main results expected | December 31, 2036 |
| Study ends | December 31, 2037 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07640802 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are youths 8–16.5 years old with severe irritability and at least one parent participant.
✕Probably not a fit
Some participants may not experience benefit, particularly if irritability is driven by other conditions or not responsive to psychotherapy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study compares learning-based active therapies to a non-active control, focusing on irritability in children and adolescents. Participants and their caregivers will complete 28 visits over 18 months, including 12 weekly therapy sessions. The active treatments include exposure therapy for the child with parental psychoeducation and support, or parent management therapy with child psychoeducation and support. A non-active control matches the time with a therapist but delivers psychoeducation without new skill-building. Prior work suggests exposure therapy may help irritability when combined with parent training, and this study aims to test two active approaches against the control.
Why it matters
Potential benefit: If successful, the active therapies could reduce irritability and improve functioning for affected youths and families.
How similar studies have gone: Preliminary IRB work showed efficacy for exposure therapy with parent training, supporting further study of active, skill-building approaches.
Who can join: the full rules
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA FOR YOUTH: 1. Age 8-16.5 years 2. Caregiver and/or child reports irritability as a primary clinical concern. Specifically, compared to his/her peers, the child exhibits markedly increased reactivity to negative emotional stimuli that manifests verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and/or precipitating event), verbal rages, and/or aggression toward people or property. 2a. Such events occur, on average, at least three times a week. 2b. This irritability is impairing in at least two of three domains (home, school, peers) 3\. Patients must be fluent in English 3a. Participants must be able to speak and read English. This study evaluates English language, manualized psychotherapies. The intervention materials, therapist and rater training and supervision procedures, fidelity ratings, and primary outcome measure are currently available and validated only in English. Because psychotherapy relies on nuanced verbal exchange, use of translation or interpreters could alter treatment content, affect therapeutic alliance, compromise fidelity, and limit accurate clinical risk assessment. Examining fidelity and alliance/support are our primary and secondary objective in this study. Therefore, enrolling non-English speakers can introduce a confound to these research questions. Restricting enrollment to English-speaking participants is therefore necessary to ensure participant safety and scientific validity in this trial. Critically, this eligibility criterion is based solely on the language requirements of the intervention and study procedures and is not intended to exclude participants on the basis of race or ethnicity or any other factors. 4\. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his/her current treatment is no more than minimal (i.e. CGI-S of 3 or more). 5\. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and/or psychotherapeutic interventions, two weeks prior to enrollment. INCLUSION CRITERIA FOR PARENT: 1. Parent of a child eligible for this protocol that can attend 12 parent sessions 2. Fluent in English EXCLUSION CRITERIA FOR YOUTH: Participants will be screened to exclude participants who would not be able to engage in psychotherapy. 1. Active major depressive disorder or history of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), conduct disorder, have active suicidal intent or plan as detected on screening instruments. 2. IQ \< 70 as assessed by a WASI or assessment by trained clinical staff 3. Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data. EXCLUSION CRITERIA FOR PARENTS: 1. IQ \< 70 2. Have any serious medical, mental health, or any condition that interferes with participation, such as active psychosis. 3. Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g. Antabuse or opiate treatment but not including self-help groups).
Where it's running
-
National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Melissa A Brotman, Ph.D. — National Institute of Mental Health (NIMH)
- Study coordinator: Melissa A Brotman, Ph.D.
- Email: irritablekids@mail.nih.gov
- Phone: (301) 435-6645
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.