Digital Parent Training for Disruptive Behaviors in Children

NCT03697837 | Completed

• 2 other identifiers: 0102012121-E18-004680
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Feasibility measured by Program completion

  Measured by completion of 80% or more of the modules

  Endpoint- Week 6

• Feasibility measured by Attendance

  Attendance to two of the three videoconferencing sessions

  Endpoint- Week 6

• Acceptability measured by Patient Satisfaction Questionnaires

  15-item scale measuring satisfaction of participants with clinical intervention

  Endpoint- Week 6

Secondary Outcomes (5)

• Disruptive Behavior Rating Scale

  Baseline (Week 0) and End-point (Week 6)

• MAP-DB- Multidimensional Assessment of Preschool Disruptive Behavior

  Baseline (Week 0) and End-point (Week 6)

• SNAP-Swanson, Nolan and Pelham Questionnaire (SNAP)

  Baseline (Week 0) and Endpoint (Week 6)

• CBCL - Child Behavior Checklist

  Baseline (Week 0) and Endpoint (Week 6)

• ARI-Affective Reactivity Index

  Screening (Week 0) and Endpoint (Week 6)

Study Arms (1)

Parent Management Training

EXPERIMENTAL

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

Behavioral: Parent Management Training

Interventions

Parent Management Training BEHAVIORAL

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.

Also known as: Digitally-delivered Parent Management Training, PMT

Parent Management Training

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06530, United States

Location

Related Publications (1)

• 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.

  PMID: 33035067 DERIVED

Related Links

• Web-based platform for digitally delivered intervention

MeSH Terms

Conditions

Problem Behavior; Patient Compliance

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Denis G Sukhodolsky, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• Andrea Diaz Stransky, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open feasibility trial

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 5, 2018
• Study Start: September 18, 2018
• Primary Completion: February 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-12

Locations

US (1)