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.
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.
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
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.
Other
Prospective
Psychotherapy
BehavioralEither parent management training alone or parent management training with a digital tool.
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.
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.
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 score.
Brief Irritability Test (BITe)
A 5-item self-report measure assessing irritability over the past two weeks on a 6-point scale.
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).
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