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

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ClinicalTrials.gov Identifier: NCT02723916
Recruitment Status : Active, not recruiting
First Posted : March 31, 2016
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Susan Breitenstein, 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.

Condition or disease Intervention/treatment Phase
Parent Training Primary Care Behavioral: ezParent Program Behavioral: Health-e Kids Control App Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Actual Study Start Date : September 1, 2015
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: Intervention: ezParent Program Behavioral: ezParent Program
Tablet-based behavioral parent training program.
Other Name: previously called eCPP

Active Comparator: Control: Health-e Kids App Behavioral: Health-e Kids Control App
Tablet based health promotion information App




Primary Outcome Measures :
  1. Change in Parenting Behaviors [ Time Frame: baseline, 3-, 6-, and 12-months post baseline ]
    measured by the Parent Questionnaire (PQ)


Secondary Outcome Measures :
  1. Change in Parent Behaviors [ Time Frame: baseline, 3-, 6-, and 12-months post baseline ]
    measured by the Parenting Young Children (PARYC)

  2. Evaluate the cost of delivering the ezParent Program in Primary Care [ Time Frame: site and clinician (during 9 month recruitment period); participant (during 12-month study period) ]
    evaluate participant, site, and clinician costs for delivering the ezParent Program

  3. REAIM model to evaluate implementation of ezParent in primary care [ Time Frame: site and clinician (during 9 month recruitment period) ]
    evaluate participant, site, and clinician implementation processes of the ezParent Program

  4. Change in child behavior problems [ Time Frame: baseline, 3-, 6-, and 12-months post baseline ]
    measured by the Strengths and Difficulties Questionnaire (SDQ)

  5. Change in child externalizing behavior problems [ Time Frame: baseline, 3-, 6-, and 12-months post baseline ]
    measured by the Eyberg Child Behavior Inventory (ECBI)

  6. Change in Parenting Stress [ Time Frame: baseline, 3-, 6-, and 12-months post baseline ]
    measured by the Parenting Stress Index-Short Form (PSI-SF)

  7. Change in Parenting Self-efficacy [ Time Frame: baseline, 3-, 6-, and 12-months post baseline ]
    measured by the Parenting Sense of Competence Scale (PSOC)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723916


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center

Publications:
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Responsible Party: Susan Breitenstein, Associate Professor, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02723916     History of Changes
Other Study ID Numbers: ORA# 15012705
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Susan Breitenstein, Rush University Medical Center:
Parents
Child
Preschool
eHealth