Digital Parent Training for Disruptive Behaviors in Children

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 25, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

September 18, 2018

Estimated Primary Completion Date

November 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Feasibility measured by Program completion[ Time Frame: Endpoint- Week 6 ]

Measured by completion of 80% or more of the modules

Feasibility measured by Attendance[ Time Frame: Endpoint- Week 6 ]

Attendance to two of the three videoconferencing sessions

Acceptability measured by Patient Satisfaction Questionnaires[ Time Frame: Endpoint- Week 6 ]

15-item scale measuring satisfaction of participants with clinical intervention

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Disruptive Behavior Rating Scale[ Time Frame: Baseline (Week 0) and End-point (Week 6) ]
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).
MAP-DB- Multidimensional Assessment of Preschool Disruptive Behavior[ Time Frame: Baseline (Week 0) and End-point (Week 6) ]
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.
SNAP-Swanson, Nolan and Pelham Questionnaire (SNAP)[ Time Frame: Baseline (Week 0) and Endpoint (Week 6) ]
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.
CBCL - Child Behavior Checklist[ Time Frame: Baseline (Week 0) and Endpoint (Week 6) ]
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.
ARI-Affective Reactivity Index[ Time Frame: Screening (Week 0) and Endpoint (Week 6) ]
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.

Descriptive Information

Brief Title ^ICMJE

Digital Parent Training for Disruptive Behaviors in Children

Official Title ^ICMJE

Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description: Open feasibility trial
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

Experimental: Parent Management Training
Parents will receive a web-based parenting intervention for tantrums and disruptive behavior in young children

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 1, 2019

Estimated Primary Completion Date

November 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

3 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Denis G Sukhodolsky, Ph.D. Yale University
Principal Investigator: Andrea Diaz Stransky, M.D. Yale University

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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