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Digital Parent Training for Disruptive Behaviors in Children

NCT ID: NCT03697837

Last Updated: 2020-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-18

Study Completion Date

2020-06-01

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open feasibility trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Parent Management Training

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

Group Type EXPERIMENTAL

Parent Management Training

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Digitally-delivered Parent Management Training PMT

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denis G Sukhodolsky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Andrea Diaz Stransky, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale Child Study Center

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33035067 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.mindnesthealth.com/

Web-based platform for digitally delivered intervention

Other Identifiers

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18-004680

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0102012121-E

Identifier Type: -

Identifier Source: org_study_id