Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool

NCT07764536 | Not Yet Recruiting

• 2 other identifiers: 10002714002714-M
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Pediatric disruptive behavior disorders (DBDs) are characterized by severe irritability, anger, and temper outbursts. The primary way to treat children with DBDs is parent management training (PMT). PMT teaches parents how to reward desired behaviors and not to reward undesired ones. Researchers want to find out if a smartphone app can help parents apply these skills more effectively. Objective: To test a smartphone app to enhance PMT. Eligibility: Children aged 8 to 13 years with DBDs. A parent or guardian is also needed. Design: Parents will have 12 weekly sessions of PMT. PMT teaches them how to manage their child s mood and behaviors. Parents will learn to actively ignore, praise, set limits, and handle temper outbursts. PMT can be either in person or via video. Sessions last 30 to 60 minutes. They will be video and audio recorded. Parents will be divided into 2 groups. Only 1 group will download a smartphone app. The app helps parents practice PMT skills. It offers videos, a resource library, and alerts when a child may be at risk for various behaviors. All parents will be prompted every day to answer questions about their child s mood and their own behavior. These will continue until 12 weeks after their last PMT session. Children will also answer questions on their phone daily for 1 week at a time. They will do this on 3 different weeks, each about 2 months apart. They will also have check-ins by phone every 2 weeks for up to 6 months. Parents will have follow-up calls 3, 6, and 12 months after they finish PMT.

Conditions

Disruptive Behavior Disorders; Conduct Disorder; Oppositional Defiant Disorder; Attention-deficit/Hyperactivity Disorder

Keywords

Disruptive Behavior Disorders; Parent Management Training; Children; Parents; Digital tool; Irritability; Temper outbursts

Outcome Measures

Primary Outcomes (1)

• Dropout in each arm of the trial

  Differential participant dropout in Group 1 (parent management training + digital tool) compared to Group 2 (parent management training + no digital tool) by parent management training session 12.

  By parent management training session 12

Secondary Outcomes (8)

• Clinician Affective Reactivity Index (CL-ARI)

  Pre-treatment, bi-weekly during treatment, mid-treatment, post-treatment, follow up (3-, 6-, and 12-months)

• Affective Reactivity Index (ARI)

  Pre-treatment, weekly during treatment, mid-treatment, post-treatment

• Brief Irritability Test (BITe)

  Pre-treatment, mid-treatment, post-treatment

• Clinical Global Impressions Improvement (CGI-I)

  Pre-treatment, mid-treatment, post-treatment, follow up (3-, 6-, and 12-months)

• Clinical Global Impressions Severity (CGI-S)

  Pre-treatment, bi-weekly during treatment, mid-treatment, post-treatment, follow up (3-, 6-, and 12-months)

Study Arms (2)

Children/adolescents with irritability

Children/adolescents with irritability

Parents/guardians of children/adolescents with irritability

Parents/guardians of children/adolescents with irritability

Behavioral: Psychotherapy

Interventions

Psychotherapy BEHAVIORAL

Either parent management training alone or parent management training with a digital tool.

Parents/guardians of children/adolescents with irritability

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This study is for children 8-13 years old with irritability as a primary clinical concern and no more than minimal response to current treatment. At least one parent/guardian must be willing to enroll and have the cognitive ability to consent, and the child must be able to understand and willing to sign a written assent document. The enrolled, consented parent must be willing to attend 12 parent management training sessions and use the study s digital tool. Both parent and child must be fluent in English. Exclusion criteria for children are active major depression or history of psychosis, bipolar I disorder, level 2 or 3 autism spectrum disorder, active severe substance use, active suicidal intent or plan, IQ below 70, or medical or neurological conditions that may interfere with study participation. Exclusion criteria for parents are IQ below 70, medical/mental health conditions that interfere with participation, or current substance or alcohol problems requiring separate treatment.

You may qualify if:

• Enrollment into protocol 01-M-0254 for screening purposes
• Age 8-13 years (8 years 0 months through 13 years 11 months)
• Parent/guardian 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 is manifest 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. This criterion is assessed based on the clinical interview conducted with parent/guardian and child after consenting into protocol 01-M-0254 for screening.
• On the basis of record review and interviews with child and parent or guardian, 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). This criterion is assessed based on the clinical interview conducted with parent/guardian and child after consenting into protocol 01-M-0254 for screening.
• Patients must be fluent in (speaking, reading) English after consenting into protocol 01-M-0254 as determined through clinical judgement.
• This study uses English-language manualized PMT. The PMT intervention materials, digital tool, therapist and rater training and supervision procedures, fidelity ratings, and outcome measures 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. Enrolling non-English speakers can introduce a confound to our research objectives around feasibility, symptom and behavior change, and acceptability and fidelity. 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.
• At least one parent or guardian of the minor subject must be willing to enroll in the protocol and have the cognitive ability to consent.
• The minor subject must be able understand a written assent document as determined through clinical judgement, as well as be willing to sign a written assent document.
• Enrollment into 01-M-0254 for screening purposes
• Parent or guardian of a child eligible for this protocol that can attend 12 PMT sessions and is willing to use the digital tool
• Fluent in English after consenting into protocol 01-M-0254 as determined through clinical judgement
• Ability of parent or guardian to understand the consent form and the willingness to sign a written informed consent document

You may not qualify if:

• 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), 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 as assessed via a neuropsychological assessment or via assessment by trained clinical staff
• 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

Attention Deficit and Disruptive Behavior Disorders; Conduct Disorder; Oppositional Defiant Disorder; Attention Deficit Disorder with Hyperactivity

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

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) 435-6645; 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: August 13, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): August 19, 2026
• Primary Completion (Estimated): December 31, 2036
• Study Completion (Estimated): December 31, 2037
• Last Updated: August 14, 2026

Record last verified: 2026-08-11

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)