Clinical trial Recruiting at 1 site Observational Ages 8 to 17

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.

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Quick facts

Study typeObservational
Ages8 Years to 17 Years
SexAll
Enrollment410 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Bethesda, Maryland)
StatusRecruiting
StartedNovember 15, 2026
Main results expectedDecember 31, 2036
Study endsDecember 31, 2037
Registry record updatedNovember 10, 2026
Trial IDNCT07640802 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.