Digital Parent Training for Disruptive Behaviors in Children

Anger Clinical Trial

Official title:

Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03697837
• Other study ID #: 0102012121-E
• Secondary ID: 18-004680
• Status: Completed
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: December 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Aggression Childhood
• Anger
• Disruptive Behavior
• Irritable Mood
• Non-Compliance, Patient
• Problem Behavior

Intervention

Behavioral:
• Parent Management Training
The online digital parent training (DPT) program consists of 8 self-guided courses that take approximately 10 minutes to complete and include text and animated parent-child simulations. The courses are designed to closely parallel the content of existing evidence-based parent management training approaches that exist in numerous parenting books.

Locations

Country	Name	City	State
United States	Yale Child Study Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility measured by Program completion	Measured by completion of 80% or more of the modules	Endpoint- Week 6
Primary	Feasibility measured by Attendance	Attendance to two of the three videoconferencing sessions	Endpoint- Week 6
Primary	Acceptability measured by Patient Satisfaction Questionnaires	15-item scale measuring satisfaction of participants with clinical intervention	Endpoint- Week 6
Secondary	Disruptive Behavior Rating Scale	16-item rating scale used to assess inattention, hyperactivity-impulsivity, and oppositional defiant behavior among school-aged children. It includes two 8 question subscales, one of which assesses the frequency of these constructs while the other assesses the interference of these constructs in different parts of the child's life. Each item is graded between 0-3 so that each sub-scale has a maximum score of 24 and a minimum score of 0 with a total range of 24. The two subscales are not combined in any way. Higher values are a worse outcome as they either represent a greater frequency or interference (depending on the sub-scale).	Baseline (Week 0) and End-point (Week 6)
Secondary	MAP-DB- Multidimensional Assessment of Preschool Disruptive Behavior	A developmentally sensitive questionnaire that includes ~74 items, to assess frequency of temper loss in terms of tantrum features and anger regulation in preschool-aged children. Will perform a preliminary evaluation of intervention effectiveness by assessing change in pre-post scores. Each item is rated on a 6-point likert scale ranging between "never" to "many times each day". The scoring system for this measure is not published, but the authors of this novel tool have agreed to assist in the scoring of this scale.	Baseline (Week 0) and End-point (Week 6)
Secondary	SNAP-Swanson, Nolan and Pelham Questionnaire (SNAP)	Parent and teacher questionnaires with 18 scored items. Items 1-9 assess inattention in children, while items 11-19 assess hyperactivity in children. Each item ranges between 0-3. Items 10 and 20 are not scored. The higher the score, the worse the outcome as the higher scores reflect greater frequency in the child's inattention or hyperactivity. The two sub-scales are not combined.	Baseline (Week 0) and Endpoint (Week 6)
Secondary	CBCL - Child Behavior Checklist	The Child Behavior Checklist is a parent rating of child psychopathology that has factor-analytically derived scales of anxiety, depression, and disruptive behavior. It includes 7 general questions about the child's preferences and activities, and 113 items to assess childhood behavior. We will use it to obtain a more detailed characterization of psychopathology in children.	Baseline (Week 0) and Endpoint (Week 6)
Secondary	ARI-Affective Reactivity Index	ARI is a 7-item measure of irritability in children and adolescents. Items are rated between 0-2, except for the last item (Number 7) which is not used for scoring. The scale has a minimum score of 0 and a maximum score of 12. An "Affective Reactivity Index Average Score" will be calculated, which is the total score divided by 6. The higher the score, the worse the outcome as this represents greater problems related to irritability. There are no subscales in this measure.	Screening (Week 0) and Endpoint (Week 6)

External Links

•   Description Information about the study team on the Yale University Child Study Center website
•   Publication of results
•   Web-based platform for digitally delivered intervention