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

Not Applicable

Completed

Conditions: Parent Training
Primary Care

Interventions: Behavioral: ezParent Program
Behavioral: Health-e Kids Control App

Registration Number: NCT02723916

Lead Sponsor: Rush University Medical Center

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 287

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: ezParent Program	ezParent Program	-
Control: Health-e Kids App	Health-e Kids Control App	-

Primary Outcome Measures

Name	Time	Method
Parenting Behaviors	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

Secondary Outcome Measures

Name	Time	Method
Change in Child Behavior Problems	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)
Change in Child Externalizing Behavior Problems	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
Change in Parent Behaviors	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
Change in Parenting Stress	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
Change in Parenting Self-efficacy	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