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Digital Parent Training for Disruptive Behaviors in Children

Primary Purpose

Disruptive Behavior, Aggression Childhood, Anger

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Management Training
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disruptive Behavior

Eligibility Criteria

3 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale Child Study Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parent Management Training

Arm Description

Parents will receive a web-based parenting intervention for tantrums and disruptive behavior in young children

Outcomes

Primary Outcome Measures

Feasibility measured by Program completion
Measured by completion of 80% or more of the modules
Feasibility measured by Attendance
Attendance to two of the three videoconferencing sessions
Acceptability measured by Patient Satisfaction Questionnaires
15-item scale measuring satisfaction of participants with clinical intervention

Secondary Outcome Measures

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).
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.
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.
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.
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.

Full Information

First Posted
September 25, 2018
Last Updated
December 2, 2020
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03697837
Brief Title
Digital Parent Training for Disruptive Behaviors in Children
Official Title
Cognitive-Behavioral Therapy for Disruptive Behavior in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disruptive Behavior, Aggression Childhood, Anger, Non-Compliance, Patient, Irritable Mood

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open feasibility trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent Management Training
Arm Type
Experimental
Arm Description
Parents will receive a web-based parenting intervention for tantrums and disruptive behavior in young children
Intervention Type
Behavioral
Intervention Name(s)
Parent Management Training
Other Intervention Name(s)
Digitally-delivered Parent Management Training, PMT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility measured by Program completion
Description
Measured by completion of 80% or more of the modules
Time Frame
Endpoint- Week 6
Title
Feasibility measured by Attendance
Description
Attendance to two of the three videoconferencing sessions
Time Frame
Endpoint- Week 6
Title
Acceptability measured by Patient Satisfaction Questionnaires
Description
15-item scale measuring satisfaction of participants with clinical intervention
Time Frame
Endpoint- Week 6
Secondary Outcome Measure Information:
Title
Disruptive Behavior Rating Scale
Description
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).
Time Frame
Baseline (Week 0) and End-point (Week 6)
Title
MAP-DB- Multidimensional Assessment of Preschool Disruptive Behavior
Description
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.
Time Frame
Baseline (Week 0) and End-point (Week 6)
Title
SNAP-Swanson, Nolan and Pelham Questionnaire (SNAP)
Description
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.
Time Frame
Baseline (Week 0) and Endpoint (Week 6)
Title
CBCL - Child Behavior Checklist
Description
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.
Time Frame
Baseline (Week 0) and Endpoint (Week 6)
Title
ARI-Affective Reactivity Index
Description
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.
Time Frame
Screening (Week 0) and Endpoint (Week 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis G Sukhodolsky, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Diaz Stransky, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06530
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33035067
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.
Results Reference
derived
Links:
URL
https://medicine.yale.edu/childstudy/faculty/denis_sukhodolsky.profile
Description
Description Information about the study team on the Yale University Child Study Center website
URL
https://www.mindnesthealth.com/
Description
Web-based platform for digitally delivered intervention
URL
https://www.liebertpub.com/doi/10.1089/cap.2020.0089
Description
Publication of results

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Digital Parent Training for Disruptive Behaviors in Children

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