IrritabilityNCT07640802
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
An observational study of Irritability and Disruptive Mood Dysregulation Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Irritability, Disruptive Mood Dysregulation Disorder, Oppositional Defiant Disorder
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 410 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2026to 31 Dec 2037
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
- 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
Show all 11Show fewer
- 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.
- Parent of a child eligible for this protocol that can attend 12 parent sessions
- Fluent in English
Who cannot join
- 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 as assessed by a WASI or assessment by trained clinical staff
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: 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 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.
Read more
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.
Read the 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:
- 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).
- 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:
- 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.
- 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.
- In all conditions, examine therapeutic support (measured by child/parent and clinician working alliance inventory measure).
- 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:
- 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.
- 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:
- 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).
- 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:
- 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)
- Determine if degree of exposure in exposure plus parental psychoeducation supportive psychotherapy condition is associated with level of clinical improvement (Secondary Objective 2).
- Determine if degree of therapeutic support (measured by child/parent and clinician working alliance inventory measure) is associated with clinical response (Secondary Objective 3).
- Determine stability of clinical assessments 3, 6, and 12 months later (Secondary Objective 4).
Exploratory Endpoint:
- 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.
- 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).
- Conditions
- Irritability, Disruptive Mood Dysregulation Disorder, Oppositional Defiant Disorder, Attention Deficit Hyperactivity Disorder
- Being tested
- Psychotherapy
- Keywords
- Irritability, Parent Management Training, Psychosocial Treatment, Exposure Therapy, Children, ANGER, Pediatric, Cognitive Behavioral Therapy, Psychoeducation, Supportive Therapy
- Medical subject headings
- Oppositional Defiant Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Participants will receive either exposure-based cognitive behavioral therapy, parent management training, or psychoeducation supportive psychotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Children/Adolescents with severe irritability | Children/Adolescents with severe irritability Receives: Behavioral: Psychotherapy | |
| Parents/Caregivers of children/adolescents with severe irritability | Parents/Caregivers of children/adolescents with severe irritability Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post each psychotherapy session
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Pre, mid, post, and f/u
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start11 Nov 2026 (estimated)
- Primary completion31 Dec 2036 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IrritabilityStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Melissa A Brotman, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640802
- Sponsor's protocol ID
- 10002713
- Other IDs
- 002713-M
- Status last verified
- 1 Oct 2026
- First submitted
- 10 Jun 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapy for Irritability in Youth: Comparing Active Treatment to Non-Active Psychoeducation Supportive Psychotherapy
- ClinicalTrials.gov ID
- NCT07640802
- Acronym / sponsor ID
- 10002713
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 11 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2036 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
- 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:
- 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.
- 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.
- In all conditions, examine therapeutic support (measured by child/parent and clinician working alliance inventory measure).
- 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:
- 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.
- 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:
- 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).
- 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:
- 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)
- Determine if degree of exposure in exposure plus parental psychoeducation supportive psychotherapy condition is associated with level of clinical improvement (Secondary Objective 2).
- Determine if degree of therapeutic support (measured by child/parent and clinician working alliance inventory measure) is associated with clinical response (Secondary Objective 3).
- Determine stability of clinical assessments 3, 6, and 12 months later (Secondary Objective 4).
Exploratory Endpoint:
- 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.
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children/Adolescents with severe irritability | – | Behavioral: PsychotherapyChildren/Adolescents with severe irritability |
| Parents/Caregivers of children/adolescents with severe irritability | – | Behavioral: PsychotherapyParents/Caregivers of children/adolescents with severe irritability |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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 as assessed by a WASI or assessment by trained clinical staff
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychotherapyParticipants will receive either exposure-based cognitive behavioral therapy, parent management training, or psychoeducation supportive psychotherapy. | Behavioural | Children/Adolescents with severe irritability, Parents/Caregivers of children/adolescents with severe irritability |
Primary outcome
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.
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)
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.
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.
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.
10 secondary outcomes
Affective Reactivity Index (ARI)
Time frame: Weekly
Brief Irritability Test (BITe)
Time frame: Pre, mid, post
Pediatric Anxiety Rating Scale (PARS)
Time frame: Pre, mid, post, and f/u
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time frame: Pre, mid, post
ADHD Rating Scale (ADHD-RS)
Time frame: Pre, mid, post, and f/u
Conners Parent Rating Scale Revised (CPRS-R)
Time frame: Pre, mid, post
Child Depression Rating Scale Revised (CDRS-R)
Time frame: Pre, mid, post, and f/u
Mood and Feelings Questionnaire (MFQ)
Time frame: Pre, mid, post
Children s Global Assessment Scale (CGAS):
Time frame: Pre, mid, post, and f/u
Clinical Global Impressions Severity (CGI-S)
Time frame: Pre, mid, post, and f/u
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa A Brotman, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritability and Disruptive Mood Dysregulation Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa A Brotman, Ph.D. ((301) 435-6645, irritablekids@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Affective Reactivity Index (CL-ARI) (time frame: Bi-weekly and f/u). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.