Clinical trial NCT03697837: Digital Parent Training for Disruptive Behaviors in Children
Official title: Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disruptive Behavior
Aggression Childhood
Anger
Non-Compliance, Patient
Irritable Mood
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 16
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open feasibility trial
Primary purpose: TREATMENT

Brief summary: This is an open pilot trial of web-based parent training for tantrums and disruptive behavior in children. Parents will be asked to complete a battery of tests to assess their children' behaviors before and after the intervention. Children will undergo a psychiatric evaluation as part of screening. The intervention will be delivered online via an app over a period of 6 weeks. It consists of 8 self-guided courses that take approximately 10 minutes to complete and include text and animated parent-child simulations. Parents will also complete 3 one-hour videoconferencing sessions with a study clinician. During the intervention, parents will be taught various strategies for managing situations that can be anger provoking for their child. This study is conducted to examine whether a digitally-delivered version of parent-management training can be used to reduce behavioral problems including anger outbursts, irritability, aggression and noncompliance.


Eligibility criteria: Inclusion Criteria:

* Parents have access to a mobile device and/or computer device
* Parents speak English as native language
* Families agree not to initiate new mental health treatments for the duration of this study.
* Child meets diagnostic criteria for one of the Disruptive Behavior Disorders
* Affective Reactivity Index parent-report score is above 3.6, which is the mean for children with severe irritability
* Lives within driving distance from New Haven, CT

Exclusion Criteria:

* Parents have previously received parent-training by a licensed provider.
* Untreated medical or psychiatric disorder that requires immediate intervention
* Child is non-verbal or minimally verbal

Primary outcomes:
measure: Feasibility measured by Program completion
timeFrame: Endpoint- Week 6
measure: Feasibility measured by Attendance
timeFrame: Endpoint- Week 6
measure: Acceptability measured by Patient Satisfaction Questionnaires
timeFrame: Endpoint- Week 6
Secondary outcomes:
measure: Disruptive Behavior Rating Scale
timeFrame: Baseline (Week 0) and End-point (Week 6)
measure: MAP-DB- Multidimensional Assessment of Preschool Disruptive Behavior
timeFrame: Baseline (Week 0) and End-point (Week 6)
measure: SNAP-Swanson, Nolan and Pelham Questionnaire (SNAP)
timeFrame: Baseline (Week 0) and Endpoint (Week 6)
measure: CBCL - Child Behavior Checklist
timeFrame: Baseline (Week 0) and Endpoint (Week 6)
measure: ARI-Affective Reactivity Index
timeFrame: Screening (Week 0) and Endpoint (Week 6)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Denis G Sukhodolsky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Andrea Diaz Stransky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diaz-Stransky A, Rowley S, Zecher E, Grodberg D, Sukhodolsky DG. Tantrum Tool: Development and Open Pilot Study of Online Parent Training for Irritability and Disruptive Behavior. J Child Adolesc Psychopharmacol. 2020 Nov;30(9):558-566. doi: 10.1089/cap.2020.0089. Epub 2020 Oct 9.