Digital Parent Training for Disruptive Behaviors in Children

December 2, 2020 updated by: Yale University

Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06530
        • Yale Child Study Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Parent Management Training
Parents will receive a web-based parenting intervention for tantrums and disruptive behavior in young children
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.
Other Names:
  • PMT
  • Digitally-delivered Parent Management Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility measured by Program completion
Time Frame: Endpoint- Week 6
Measured by completion of 80% or more of the modules
Endpoint- Week 6
Feasibility measured by Attendance
Time Frame: Endpoint- Week 6
Attendance to two of the three videoconferencing sessions
Endpoint- Week 6
Acceptability measured by Patient Satisfaction Questionnaires
Time Frame: Endpoint- Week 6
15-item scale measuring satisfaction of participants with clinical intervention
Endpoint- Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (Week 0) and End-point (Week 6)
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.
Baseline (Week 0) and End-point (Week 6)
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.
Baseline (Week 0) and Endpoint (Week 6)
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.
Baseline (Week 0) and Endpoint (Week 6)
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.
Screening (Week 0) and Endpoint (Week 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Andrea Diaz Stransky, M.D., Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 18, 2018

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

June 1, 2020

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

October 3, 2018

First Posted (ACTUAL)

October 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 2, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0102012121-E
  • 18-004680 (OTHER_GRANT: AACAP- Elaine Schlosser Lewis Fund)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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