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

NCT ID: NCT02723916

Last Updated: 2020-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2019-06-30

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.

Conditions

Parent Training; Primary Care

Keywords

Parents; Child; Preschool; eHealth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention: ezParent Program

Group Type: EXPERIMENTAL

ezParent Program

Intervention Type: BEHAVIORAL

Tablet-based behavioral parent training program.

Control: Health-e Kids App

Group Type: ACTIVE_COMPARATOR

Health-e Kids Control App

Intervention Type: BEHAVIORAL

Tablet based health promotion information App

Interventions

ezParent Program

Tablet-based behavioral parent training program.

Intervention Type: BEHAVIORAL

Health-e Kids Control App

Tablet based health promotion information App

Intervention Type: BEHAVIORAL

Other Intervention Names

previously called eCPP

Eligibility Criteria

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.

• Parent previously used the ezPARENT program.

Exclusion Criteria

• Only one parent per family

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Susie Breitenstein

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

References

Breitenstein SM, Laurent S, Pabalan L, Risser HJ, Roper P, Saba MT, Schoeny M. Implementation findings from an effectiveness-implementation trial of tablet-based parent training in pediatric primary care. Fam Syst Health. 2019 Dec;37(4):282-290. doi: 10.1037/fsh0000447. Epub 2019 Oct 17.

Reference Type: RESULT

PMID: 31621349 (View on PubMed)

Fehrenbacher C, Schoeny ME, Reed M, Shattell M, Breitenstein SM. Referral to Digital Parent Training in Primary Care: Facilitators and Barriers. Clin Pract Pediatr Psychol. 2020 Sep;8(3):268-277. doi: 10.1037/cpp0000367.

Reference Type: RESULT

PMID: 35821979 (View on PubMed)

Breitenstein SM, Fehrenbacher C, Holod AF, Schoeny ME. A Randomized Trial of Digitally Delivered, Self-Administered Parent Training in Primary Care: Effects on Parenting and Child Behavior. J Pediatr. 2021 Apr;231:207-214.e4. doi: 10.1016/j.jpeds.2020.12.016. Epub 2020 Dec 16.

Reference Type: DERIVED

PMID: 33338496 (View on PubMed)

Breitenstein SM, Schoeny M, Risser H, Johnson T. A study protocol testing the implementation, efficacy, and cost effectiveness of the ezParent program in pediatric primary care. Contemp Clin Trials. 2016 Sep;50:229-37. doi: 10.1016/j.cct.2016.08.017. Epub 2016 Aug 31.

Reference Type: BACKGROUND

PMID: 27592122 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ORA# 15012705

Identifier Type: -

Identifier Source: org_study_id