Attention-deficit/Hyperactivity Disorder, Conduct Disorder, Disruptive Behavior Disorders, Oppositional Defiant Disorder
Conditions
Keywords
Disruptive Behavior Disorders, Parent Management Training, Children, Parents, Digital tool, Irritability, Temper outbursts
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.
Detailed description
Study Description: This study is a feasibility study (N=60 parent-child dyads) of a digital tool (machine learning and a smartphone application) augmenting parent management training (PMT) to support the reduction of irritability and temper outbursts through changes in parenting behaviors (i.e., active ignoring) for pediatric disruptive behavior disorders (DBDs). We examine the feasibility of the study design (i.e., two-arm randomized controlled trial \[RCT\] of PMT + ecological momentary assessment \[EMA\] + digital tool vs. PMT + EMA + no digital tool) and examine patterns of change in irritability, outbursts, and parenting behaviors (i.e., active ignoring). Objectives: Primary Objective: Determine the feasibility of the design of a clinical trial (i.e., RCT with two parallel arms - PMT + EMA + digital tool compared to PMT + EMA + no digital tool). Secondary Objective: * Determine whether outbursts and irritability decrease in PMT + EMA + digital tool and PMT + EMA + no digital tool. Determine whether severity of impairment decreases and general functioning improves in both groups. * Determine whether active ignoring increases in PMT + EMA + digital tool and PMT + EMA + no digital tool. Tertiary Objective: * Examine whether attention deficit/hyperactivity disorder (ADHD), anxiety, and depression symptoms decrease in PMT + EMA + digital tool and PMT + EMA + no digital tool. * Monitor treatment acceptability and fidelity and therapeutic support. Endpoints: Primary Endpoint: Dropout in each arm of the trial (PMT + EMA + digital tool vs. PMT + EMA + no digital tool). Secondary Endpoint: * Changes in child outbursts and irritability measured using the Clinician-rated Affective Reactivity Index (CLARI); parent-/child-ARI; Brief Irritability Test (BITe); and parent/child EMA (collected 3x/day from baseline through 3 months post-treatment). Changes in severity of impairment and general functioning using the Children s Global Assessment Scale (CGAS), Clinical Global Impressions Scale-Severity (CGI-S), and Clinical Global Impress Scale-Improvement (CGI-I). * Changes in active ignoring measured using parent EMA (collected 3x/day from baseline through 3 months post-treatment). Tertiary Endpoint: * Changes in symptoms of ADHD, anxiety, and depression. ADHD is measured using the ADHD Rating Scale (ADHD-RS) and Conners Parent Rating Scale (CPRS-R). Anxiety is measured using the Screen for Child Anxiety Related Disorders (SCARED) and Pediatric Anxiety Rating Scale (PARS). Depression is measured using the Mood and Feelings Questionnaire (MFQ) and Child Depression Rating Scale (CDRS). * We will monitor treatment acceptability using the Working Alliance Inventory (WAI) and treatment fidelity using an adherence scale previously developed by our group.
Interventions
BEHAVIORALPsychotherapy
Either parent management training alone or parent management training with a digital tool.
Sponsors
National Institute of Mental Health (NIMH)
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* INCLUSION CRITERIA: Inclusion Criteria for Youth: To be eligible to participate, an individual must be enrolled in the 01-M-0254 protocol. All screening will occur under 01-M-0254 and all inclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. To be eligible to participate, an individual must meet all the following criteria: * 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. Inclusion Criteria for Parent or Guardian: To be eligible to participate, an individual must be enrolled in the 01-M-0254 protocol. All screening will occur under 01-M-0254 and all inclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. To be eligible to participate, an individual must meet all the following criteria: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dropout in each arm of the trial | By parent management training session 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Affective Reactivity Index (CL-ARI) | Pre-treatment, bi-weekly during treatment, mid-treatment, post-treatment, follow up (3-, 6-, and 12-months) | 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) | Pre-treatment, weekly during treatment, mid-treatment, post-treatment | 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) | Pre-treatment, mid-treatment, post-treatment | A 5-item self-report measure assessing irritability over the past two weeks on a 6-point scale. |
| Clinical Global Impressions Improvement (CGI-I) | Pre-treatment, mid-treatment, post-treatment, follow up (3-, 6-, and 12-months) | 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). |
| Clinical Global Impressions Severity (CGI-S) | Pre-treatment, bi-weekly during treatment, mid-treatment, post-treatment, follow up (3-, 6-, and 12-months) | A clinician-rated measure of the patient s current level of psychopathology on a 7-point Likert scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients), providing a single global index of illness severity at the time of assessment. |
| The Children s Global Assessment Scale (CGAS) | Pre-treatment, bi-weekly during treatment, mid-treatment, post-treatment, follow up (3-, 6-, and 12-months) | A clinician rated, diagnosis nonspecific measure of overall functioning in children and adolescents. It provides a single global rating of the child s psychological, social, and school functioning over a specified time period (usually the current level or past week), based on all available clinical information. Scored on a 100 point continuum divided into 10 point descriptive anchor ranges, with scores ranging from 1 (most impaired functioning) to 100 (superior functioning). Higher scores indicate better overall functioning, while lower scores reflect increasing levels of impairment. |
| Ecological momentary assessment (EMA) of child temper outbursts and irritability | In both groups, parents/guardians complete EMA 3x/day from a baseline period through 12 weeks post-treatment (up to 30 weeks) and children complete EMA 3x/day for one week pre-, mid-, and post-treatment (3 weeks total) | EMA items are parent-report and child-report of child temper outbursts and irritability. |
| Ecological momentary assessment (EMA) of parent active ignoring | In both groups, parents/guardians complete EMA 3x/day from a baseline period through 12 weeks post-treatment (up to 30 weeks) | EMA items are parent-report of parent use of the active ignoring skill. |
Countries
United States
Contacts
CONTACTMelissa A Brotman, Ph.D.
PRINCIPAL_INVESTIGATORMelissa A Brotman, Ph.D.
National Institute of Mental Health (NIMH)
Outcome results
None listed