An observational study in Irritability, Disruptive Mood Dysregulation Disorder and Oppositional Defiant Disorder, sponsored by National Institute of Mental Health (NIMH). Recruiting at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by National Institute of Mental Health (NIMH) · Observational
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.
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:
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:
Secondary Endpoints:
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).
86 studies on the registry are indexed under Oppositional Defiant Disorder; 16 are open to participants now.
This study's planned enrollment of 410 is above the median of 200 across 10 observational studies indexed under Oppositional Defiant Disorder.
Browse Oppositional Defiant Disorder studies →National Institute of Mental Health (NIMH) is the lead sponsor of 367 studies on the registry; 45 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 24 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
INCLUSION CRITERIA FOR YOUTH:
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:
EXCLUSION CRITERIA FOR YOUTH:
Participants will be screened to exclude participants who would not be able to engage in psychotherapy.
EXCLUSION CRITERIA FOR PARENTS:
Children/Adolescents with severe irritability
Behavioral: 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.
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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post each psychotherapy session
Affective Reactivity Index (ARI)
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.
Time frame: Weekly
Brief Irritability Test (BITe)
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.
Time frame: Pre, mid, post
Pediatric Anxiety Rating Scale (PARS)
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.
Time frame: Pre, mid, post, and f/u
Screen for Child Anxiety Related Emotional Disorders (SCARED)
A 41-item parent- and child-report measure of recent anxiety symptoms rated on a 3-point scale, with total and subscale scores.
Time frame: Pre, mid, post
ADHD Rating Scale (ADHD-RS)
A parent-reported, clinician-administered measure of DSM-based ADHD symptoms, with inattention and hyperactivity impulsivity subscales and a total score.
Time frame: Pre, mid, post, and f/u
Conners Parent Rating Scale Revised (CPRS-R)
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
Time frame: Pre, mid, post
Child Depression Rating Scale Revised (CDRS-R)
A 17-item clinician-rated measure of depressive symptom severity in youth, based on child and parent report, with higher scores indicating greater severity.
Time frame: Pre, mid, post, and f/u
Mood and Feelings Questionnaire (MFQ)
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.
Time frame: Pre, mid, post
Children s Global Assessment Scale (CGAS):
A clinician-rated measure of overall functioning in youth, scored from 1 100, with higher scores indicating better functioning.
Time frame: Pre, mid, post, and f/u
Clinical Global Impressions Severity (CGI-S)
A clinician-rated, diagnosis-independent measure of current illness severity, scored on a 7-point scale from 1 (not ill) to 7 (extremely ill).
Time frame: Pre, mid, post, and f/u
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form, 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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