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

June 10, 2026 updated by: National Institute of Mental Health (NIMH)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Description:

This study will be a randomized psychotherapy study comparing the efficacy of learning-based active treatment teaching children/parent specific skills (either exposure therapy for irritability plus parental psychoeducation supportive psychotherapy or parent management therapy plus child psychoeducation supportive psychotherapy) vs. non active control treatment match on time with a therapist without skill advancement (child- and parent- psychoeducation supportive psychotherapy, typical current standard of care). A prior IRB protocol (15-M-0182) demonstrated efficacy of exposure therapy for irritability with parent management training. Here, we compare the learning-based active treatment (exposure with child or parent management training with parent) to non-active psychoeducation supportive psychotherapy sessions matched on time with a therapist.

Objectives:

Primary Objectives:

1. Compare the efficacy of learning based active treatment (arm 1, exposure therapy for irritability plus parental psychoeducation supportive psychotherapy or parent management therapy plus child psychoeducation supportive psychotherapy) vs. non-active support matched on time with a therapist (arm 2, child psychoeducation supportive psychotherapy plus parent psychoeducation supportive psychotherapy).

2. In each of two arms (arm 1, exposure plus parental support and parent training plus child support vs. arm 2, child and parent support), examine the degree of therapeutic adherence to exposure and parent management training, as well as support experienced by the child and parent.

Secondary Objective:

  1. Examine if adherence to learning principles skills (i.e., exposure or parent management training) and/or support (i.e., alliance) are associated with symptom improvement in anxiety, depression, and attention deficit hyperactivity symptoms. In the exposure plus parental psychoeducation supportive psychotherapy condition, determine if the degree of exposure (e.g., number of exposures) is associated with level of clinical improvement.
  2. Explore if the degree of implementation of concrete learning-based skills (e.g., exposure, active ignore, praise, parental consistency) is associated with the level of clinical response.
  3. In all conditions, examine therapeutic support (measured by child/parent and clinician working alliance inventory measure).
  4. Upon completion of the 12 sessions, conduct follow-up clinical assessments within 14 days and 3, 6, and 12 months later to determine stability of clinical improvement.

Exploratory Objective:

1. Use natural language processing to derive features/themes of sessions and determine:

1a. Similarities and differences between two treatment conditions.

1b. If specific learning related themes at specific times in treatment are associated with improvement.

2. Determine if there are specific clinical features of the child (e.g., co-occurring attention deficit hyperactivity disorder, anxiety, demographic characteristics) or the parent that are associated with improvement differentially across two active treatment conditions.

Endpoints:

Primary Endpoint:

  1. Clinical response measured by parent, child, and clinical irritability metrics (affective reactivity index and clinical severity/improvement metrics) in each treatment condition (Primary Objective 1).
  2. Association between adherence to manualized procedures (i.e., learning based skills) and alliance (i.e., degree of therapeutic support) with each treatment condition (Primary Objective 2)

Secondary Endpoints:

  1. Association between adherence to manualized procedures (i.e., learning based skills) and alliance (i.e., degree of therapeutic support) with end of treatment anxiety, depression and attention deficit hyperactivity clinical response (Secondary Objective 1)
  2. Determine if degree of exposure in exposure plus parental psychoeducation supportive psychotherapy condition is associated with level of clinical improvement (Secondary Objective 2).
  3. Determine if degree of therapeutic support (measured by child/parent and clinician working alliance inventory measure) is associated with clinical response (Secondary Objective 3).
  4. Determine stability of clinical assessments 3, 6, and 12 months later (Secondary Objective 4).

Exploratory Endpoint:

1. Using natural language processing to derive features/themes of sessions (Exploratory Endpoint 1).

1a. Examine similarities and differences between two treatment conditions

1b. Determine if specific learning related themes at specific times in treatment are associated with improvement.

2. In the pursuit of precision medicine, examine the clinical features of the child (e.g., co-occurring attention deficit hyperactivity disorder, anxiety, demographic characteristics) and the parent to assess if there is differential improvement across the two active treatment conditions associated with baseline factors (Exploratory Endpoint 2).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center
        • Contact:
          • NIH Clinical Center Office of Patient Recruitment (OPR)
          • Phone Number: TTY dial 711 800-411-1222
          • Email: ccopr@nih.gov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

  • 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

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
  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Children/Adolescents with severe irritability
Behavioral: Psychotherapy
Participants will receive either exposure-based cognitive behavioral therapy, parent management training, or psychoeducation supportive psychotherapy.
Parents/Caregivers of children/adolescents with severe irritability
Behavioral: Psychotherapy
Participants will receive either exposure-based cognitive behavioral therapy, parent management training, or psychoeducation supportive psychotherapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinician Affective Reactivity Index (CL-ARI)
Time Frame: Bi-weekly and f/u
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)
Time Frame: Relative to pre-treatment anchor and pre, mid, post and f/u
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
Time Frame: Post each psychotherapy session
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)
Time Frame: Post each psychotherapy session
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)
Time Frame: Post each psychotherapy session
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Affective Reactivity Index (ARI)
Time Frame: Weekly
A brief parent- and self-report measure of irritability with 6 core items (score range 0 12) and an additional impairment item not included in the total.
Weekly
Brief Irritability Test (BITe)
Time Frame: Pre, mid, post
A 5-item self-report measure assessing irritability over the past two weeks on a 6-point scale, designed to minimize overlap with related constructs.
Pre, mid, post
Pediatric Anxiety Rating Scale (PARS)
Time Frame: Pre, mid, post, and f/u
A clinician-administered measure of past-week anxiety severity across major domains, using a symptom checklist and severity ratings based on child and parent report.
Pre, mid, post, and f/u
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time Frame: Pre, mid, post
A 41-item parent- and child-report measure of recent anxiety symptoms rated on a 3-point scale, with total and subscale scores.
Pre, mid, post
ADHD Rating Scale (ADHD-RS)
Time Frame: Pre, mid, post, and f/u
A parent-reported, clinician-administered measure of DSM-based ADHD symptoms, with inattention and hyperactivity impulsivity subscales and a total score.
Pre, mid, post, and f/u
Conners Parent Rating Scale Revised (CPRS-R)
Time Frame: Pre, mid, post
A 28-item parent-report measure of child behavior problems (e.g., oppositionality, hyperactivity, cognitive and anxious traits), rated on a 4-point frequency scale
Pre, mid, post
Child Depression Rating Scale Revised (CDRS-R)
Time Frame: Pre, mid, post, and f/u
A 17-item clinician-rated measure of depressive symptom severity in youth, based on child and parent report, with higher scores indicating greater severity.
Pre, mid, post, and f/u
Mood and Feelings Questionnaire (MFQ)
Time Frame: Pre, mid, post
A 13-item parent- and child-report measure of depressive symptoms over the past 2 weeks, rated on a 3-point scale; scores (Bullet)29 indicate clinically significant depression.
Pre, mid, post
Children s Global Assessment Scale (CGAS):
Time Frame: Pre, mid, post, and f/u
A clinician-rated measure of overall functioning in youth, scored from 1 100, with higher scores indicating better functioning.
Pre, mid, post, and f/u
Clinical Global Impressions Severity (CGI-S)
Time Frame: Pre, mid, post, and f/u
A clinician-rated, diagnosis-independent measure of current illness severity, scored on a 7-point scale from 1 (not ill) to 7 (extremely ill).
Pre, mid, post, and f/u

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melissa A Brotman, Ph.D., National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2036

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2037

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 8, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10002713
  • 002713-M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In compliance with current NIH data-sharing policies, de-identified data from participants who have consented to data sharing will be made available in a public repository.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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