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New study aims to find best therapy for angry outbursts in kids

NCT ID NCT07640802

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 58 times

Summary

This study compares three types of therapy for children aged 8 to 16.5 with severe irritability. Participants will receive either exposure-based cognitive behavioral therapy, parent management training, or supportive psychoeducation over 12 sessions. The goal is to see which approach best reduces temper outbursts and irritable mood. The trial involves 300 youth and their parents and includes follow-up for one year after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
psychotherapy (exposure-based cognitive behavioral therapy, parent management training, or psychoeducation supportive psychotherapy)
What this could lead to
If successful, this could identify a specific therapy that effectively reduces severe irritability in children, providing a targeted treatment option.
What could go wrong
This is a relatively early-stage trial with no results yet. The therapies may not differ significantly in effectiveness, and individual responses can vary. The study is not yet recruiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 410 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2037

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study is for children ages 8-16.5 with irritability as a primary concern, including frequent verbal outbursts, or aggression in response to frustration or negative emotions. Symptoms must occur at least three times weekly and impair functioning in at least two settings, such as home, school, or with peers. A parent must be able to attend 12 parent sessions. Both children and parent must be able to speak and read English. Children are excluded for active major depression, psychosis, bipolar I disorder, level 2 or 3 autism spectrum disorder, recent severe substance use, conduct disorder, active suicidal intent or plan, IQ below 70, or significant medical or neurological conditions. Parents are excluded for IQ below 70, active psychosis, or recent substance/alcohol problems needing separate treatment.

Ages

8 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

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Other studies related to the condition(s) this trial covers.