Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy

NCT07640802 | Not Yet Recruiting

• 2 other identifiers: 10002713002713-M
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Irritability is defined as proneness to anger that may impair a person s ability to function. It is the number one reason 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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Clinician Affective Reactivity Index (CL-ARI)

  A 12-item clinician-administered measure of temper outbursts, irritable mood, and impairment over the past week, based on parent and child report.

  Bi-weekly and f/u

• Clinical Global Impressions Improvement (CGI-I)

  A clinician-rated, diagnosis-independent measure of overall treatment response, assessing change from relative to a baseline on a 7-point scale (1 = very much improved to 7 = very much worse)

  Relative to pre-treatment anchor and pre, mid, post and f/u

• CBT for Irritability-Adherence Scale

  The CBT for irritability- Adherence Scale was developed specifically for the exposure-based CBT treatment we developed. The measure contains 26 items focused on standard elements of cognitive behavioral therapy (e.g., setting agenda, homework, motivation), treatment-specific elements (e.g., exposure for the child and parent skills training for the parent), and mode of delivery elements (e.g., modeling, rehearsal, coaching). Each item is phrased as to the extent to which the therapist adheres to that task; for instance, Therapist encourages child participation in one or more exposure tasks. Therapist completes each measure for child and parent after each of the 12 sessions and rating each item on a 7-point scale: 1 = not at all, 4 = considerably, 7 = extensively.

  Post each psychotherapy session

• Working Alliance Inventory (WAI)

  The WAI (Horvath \& Greenberg, 1989) is 12-item, 7-point Likert-scale measure of alliance in the therapist-client dyad. We plan to use this measure to assess the alliance between therapist and parent. Individual item responses range from 0 ( Never ) to 6 ( Always ). Items are worded as statements on the dyadic relationship between therapist and parent. The WAI contains 3 subscales based on Bordin s (1979) analysis of the primary components of therapeutic alliance: Goal, Task, and Bond, which assess the degree to which the parent feels they agree with the therapist on the primary goals of therapy, the usefulness of the tasks completed in therapy, and feelings of trust and compatibility with the therapist, respectively. The WAI has demonstrated good reliability and validity in previous studies (Hatcher et al., 2020; Munder et al., 2010). This measure takes about 5 minutes to complete and will be administered at each session.

  Post each psychotherapy session

• Therapeutic Alliance Scale for Children-revised (TASC-r)

  The TASC-R (Shirk \& Saiz, 1992) is a 12-item measure of therapeutic alliance, as reported by the child. The TASC-r contains 2 subscales based on Bordin s (1979) therapeutic alliance research: Bond, or the degree to which the child feels a bond with the therapist, and Task, the child s assessment of whether therapy is a productive and collaborative endeavor (Bordin, 1979). The TASC-r scores have demonstrated good reliability and validity in previous studies (Creed \& Kendall, 2005; DeVet et al., 2003). This measure takes about 5 minutes to complete and will be administered at each session.

  Post each psychotherapy session

Secondary Outcomes (10)

• Affective Reactivity Index (ARI)

  Weekly

• Brief Irritability Test (BITe)

  Pre, mid, post

• Pediatric Anxiety Rating Scale (PARS)

  Pre, mid, post, and f/u

• Screen for Child Anxiety Related Emotional Disorders (SCARED)

  Pre, mid, post

• ADHD Rating Scale (ADHD-RS)

  Pre, mid, post, and f/u

Study Arms (2)

Children/Adolescents with severe irritability

Children/Adolescents with severe irritability

Behavioral: Psychotherapy

Parents/Caregivers of children/adolescents with severe irritability

Parents/Caregivers of children/adolescents with severe irritability

Behavioral: Psychotherapy

Interventions

Psychotherapy BEHAVIORAL

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

Children/Adolescents with severe irritability; Parents/Caregivers of children/adolescents with severe irritability

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age 8-16.5 years
• 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.
• a. Such events occur, on average, at least three times a week.
• b. This irritability is impairing in at least two of three domains (home, school, peers)
• \. Patients must be fluent in English
• a. 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.
• \. 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).
• \. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and/or psychotherapeutic interventions, two weeks prior to enrollment.
• Parent of a child eligible for this protocol that can attend 12 parent sessions
• Fluent in English

You may not qualify if:

• Participants will be screened to exclude participants who would not be able to engage in psychotherapy.
• 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.
• IQ \< 70
• 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.
• IQ \< 70
• Have any serious medical, mental health, or any condition that interferes with participation, such as active psychosis.
• 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).

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Oppositional Defiant Disorder; Attention Deficit Disorder with Hyperactivity

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Melissa A Brotman, Ph.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa A Brotman, Ph.D.

CONTACT

(301) 496-8281; irritablekids@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): June 17, 2026
• Primary Completion (Estimated): December 31, 2036
• Study Completion (Estimated): December 31, 2037
• Last Updated: June 12, 2026

Record last verified: 2026-06-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: De-identified data from participants who have consented to data sharing will be made available in a public repository at time of publication without an end date.
• Access Criteria: De-identified data from participants who have consented to data sharing will be made available in a public repository that can be accessed by anyone.

Locations

US (1)