Parent Training in Pediatric Care: A Self Directed Tablet-Based Approach

December 6, 2020 updated by: Susie Breitenstein, Rush University Medical Center
High quality and effective parenting in the preschool years is connected with long term positive child behavior and mental health outcomes. The purpose of the study, "Parent Training in Pediatric Primary Care: A Self-directed Tablet-based Approach," is to test the outcomes and implementation of a tablet-based parent training program in Pediatric Primary Care. Testing and evaluating the implementation of digitally delivered programs is important to increase the ease, reach, sustainability, and integration of mental health prevention into primary care settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One in four young children in the United States faces poverty-associated risks that make her or him more likely to have mental health and behavior problems. These problems, left untreated, can have long-term social, emotional, and behavioral consequences. High-quality parenting in the preschool years can substantially buffer the negative effects of socioeconomic adversity on children's mental health and behavior. However, most parent training programs use face-to-face delivery models resulting in barriers to participation and limited reach to those most in need. Testing the efficacy and implementation of alternative delivery models is needed to (a) increase the reach and sustainability of parent training interventions and (b) address the barriers to parent participation and implementation of such programs, specifically in primary health care settings. The parent training program proposed in this study is a digital adaptation (tablet-based) of the evidence-based based Chicago Parent Program (CPP) called the ezParent Program. The purpose of this study is to evaluate the efficacy, cost-effectiveness, and implementation process of delivering the ezParent in pediatric primary care sites serving low-income, urban families. The specific aims of the study are: (1) Test the direct effects of the 6-module ezParent Program on parenting outcomes (parenting behavior, parenting self-efficacy, and parenting stress) and child outcomes (child problem and prosocial behavior) compared to an enhanced usual care control condition among low-income parents with young children seen in primary care settings; (2) Compare the cost-effectiveness of the ezParent intervention relative to the control condition for the parenting and child outcomes; and (3) Quantify the levels of program implementation of the ezParent Program in primary care using the RE-AIM framework. The efficacy of the ezParent Program will be tested using a randomized clinical trial design with 312 parents of 2- to 5-year-old children from pediatric primary care settings. Data on parenting and child behavior outcomes will be obtained from all participants at baseline, and 3, 6, and 12 months post baseline. A descriptive design guided by the RE-AIM framework and cost-effectiveness analysis will evaluate the implementation of the ezParent Program in the pediatric primary care sites.

Integrating and evaluating the implementation of the ezParent Program is an innovative opportunity to promote parenting with potential for universal access to the preschool (2- to 5-year-olds) population and potential for low cost by building on existing infrastructure. Findings from this study will lay the foundation for full-scale implementation of the ezParent Program in pediatric primary care settings and subsequent implementation and dissemination research.

Study Type

Interventional

Enrollment (Actual)

287

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
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • parent, legal guardian, or primary caregiver for the target child,
  • target child is 2-5 years old,
  • child receives care at the primary practice implementation site,
  • parent can speak and read English.

Exclusion Criteria:

  • Only one parent per family
  • Parent does not meet inclusion criteria.
  • Parent previously used the ezPARENT program.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention: ezParent Program
Behavioral: ezParent Program
Tablet-based behavioral parent training program.
Other Names:
  • previously called eCPP
Active Comparator: Control: Health-e Kids App
Behavioral: Health-e Kids Control App
Tablet based health promotion information App

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parenting Behaviors
Time Frame: T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

Measured by the Parent Questionnaire (PQ)

Scale scores reported:

Warmth (scale range 1-5) - higher score indicates improvement Parent Follow Through (scale range 1-5) - higher score indicates improvement Corporal punishment (scale range 1-5) - lower score indicates improvement
T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Parent Behaviors
Time Frame: T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.
Measured by the Parenting Young Children (PARYC) Reporting scales (scale range 1-7) (higher scores indicate more effective/improved parenting) Supporting good behavior Setting limits Proactive parenting
T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.
Change in Child Behavior Problems
Time Frame: T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.
Strengths and Difficulties Questionnaire (SDQ) scales (range 0-10) Emotional symptoms (higher scores indicate more difficulties) Conduct problems (higher scores indicate more difficulties) Hyperactivity/inattention (higher scores indicate more difficulties) Peer relationship problems (higher scores indicate more difficulties) Prosocial behavior (higher scores indicate more strengths)
T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.
Change in Child Externalizing Behavior Problems
Time Frame: T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.
Eyberg Child Behavior Inventory (ECBI) Problem scale (range 0-1) higher scores more problems Intensity scale (range 1-7) higher scores more intense problems
T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.
Change in Parenting Stress
Time Frame: T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.
Parenting Stress Index-Short Form (PSI-SF) Scales (range 12-60): Higher scores indicate higher stress Parental distress Parent-child dysfunctional interaction Difficult child
T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.
Change in Parenting Self-efficacy
Time Frame: T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.
Parenting Sense of Competence Scale (PSOC) - Total Scale (Range 17-102) Higher scores indicate higher self efficacy
T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

Collaborators and Investigators

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

Sponsor

Rush University Medical Center

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

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 1, 2015

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Actual)

December 31, 2020

Last Update Submitted That Met QC Criteria

December 6, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ORA# 15012705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Primary Care

Clinical Trials on ezParent Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe