Recruiting

Therapy for Irritability

Sponsor:

National Institute of Mental Health (NIMH)

Code:

NCT07640802

Conditions

Irritability

Disruptive Mood Dysregulation Disorder

Oppositional Defiant Disorder

Attention Deficit Hyperactivity Disorder

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Psychotherapy

Study Details

Brief summary:

Background:

Irritability is defined as proneness to anger that may impair a person's ability to function. It is a common reason for why some children need mental health care. Yet no therapies have been developed just to target irritability. Researchers want to compare different types of therapy for irritability.

Objective:

To test different types of therapy for children and teens with severe irritability.

Eligibility:

People aged 8 to 16.5 years with severe irritability. Their parents are also needed.

Design:

Participants will have 28 study visits in 18 months.

They will have a baseline visit. They will answer questions about their mood, behavior, and daily life.

All parents and children will have 12 therapy sessions. Sessions will be once a week; they will last 30 to 60 minutes. Some of the child sessions may be done by telehealth.

Each parent and child will have 1 of 3 therapy types:

Exposure therapy (child). Participants will face things that make them angry. A therapist will help them practice managing their anger.

Management therapy (parent). Therapists will coach parents on ways to manage their child s behaviors.

Psychoeducation/supportive psychotherapy (child and/or parent). Participants will talk with therapists about their or their child s feelings and behaviors. They will list their problems and goals; build coping skills; learn to relax; improve communication; and work on managing stress.

Sessions may be videotaped. Participants may opt out of being recorded.

Participants will have phone calls every 2 weeks during therapy. They will answer questions about how they are doing. Follow-up calls will continue for 1 year after therapy.

Conditions

Irritability

Disruptive Mood Dysregulation Disorder

Oppositional Defiant Disorder

Attention Deficit Hyperactivity Disorder

Study ID

NCT07640802

Start date

Oct 8, 2026

Status verified date

Oct 1, 2026

Completion date

Dec 31, 2037

Anticipated

Primary completion date

Dec 31, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

  • 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).

Study Design

Enrollment

410 participants

Anticipated

Interventions and Outcome Measures

Arms

Children/Adolescents with severe irritability

Children/Adolescents with severe irritability

Parents/Caregivers of children/adolescents with severe irritability

Parents/Caregivers of children/adolescents with severe irritability

Interventions

Psychotherapy

Participants will receive either exposure-based cognitive behavioral therapy, parent management training, or psychoeducation supportive psychotherapy.

Primary outcome measure

  • Clinician Affective Reactivity Index (CL-ARI) [ Time Frame: Bi-weekly and f/u ]
  • Clinical Global Impressions Improvement (CGI-I) [ Time Frame: Relative to pre-treatment anchor and pre, mid, post and f/u ]
  • CBT for Irritability-Adherence Scale [ Time Frame: Post each psychotherapy session ]
  • Working Alliance Inventory (WAI) [ Time Frame: Post each psychotherapy session ]
  • Therapeutic Alliance Scale for Children-revised (TASC-r) [ Time Frame: Post each psychotherapy session ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Mental Health (NIMH)

Last update posted

Oct 5, 2026

Last verified

Oct 1, 2026

Keywords

  • Irritability
  • Parent Management Training
  • Psychosocial Treatment
  • Exposure Therapy
  • Children
  • ANGER
  • Pediatric
  • Cognitive Behavioral Therapy
  • Psychoeducation
  • Supportive Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH) on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.