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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 : Completed
First Posted : March 31, 2016
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Susie Breitenstein, Ohio State University

Tracking Information
First Submitted Date  ICMJE January 21, 2016
First Posted Date  ICMJE March 31, 2016
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE September 1, 2015
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2016)
Change in Parenting Behaviors [ Time Frame: baseline, 3-, 6-, and 12-months post baseline ]
measured by the Parent Questionnaire (PQ)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02723916 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2016)
  • Change in Parent Behaviors [ Time Frame: baseline, 3-, 6-, and 12-months post baseline ]
    measured by the Parenting Young Children (PARYC)
  • 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
  • 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
  • Change in child behavior problems [ Time Frame: baseline, 3-, 6-, and 12-months post baseline ]
    measured by the Strengths and Difficulties Questionnaire (SDQ)
  • Change in child externalizing behavior problems [ Time Frame: baseline, 3-, 6-, and 12-months post baseline ]
    measured by the Eyberg Child Behavior Inventory (ECBI)
  • Change in Parenting Stress [ Time Frame: baseline, 3-, 6-, and 12-months post baseline ]
    measured by the Parenting Stress Index-Short Form (PSI-SF)
  • Change in Parenting Self-efficacy [ Time Frame: baseline, 3-, 6-, and 12-months post baseline ]
    measured by the Parenting Sense of Competence Scale (PSOC)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Parent Training in Pediatric Care: A Self Directed Tablet-Based Approach
Official Title  ICMJE Not Provided
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Parent Training
  • Primary Care
Intervention  ICMJE
  • Behavioral: ezParent Program
    Tablet-based behavioral parent training program.
    Other Name: previously called eCPP
  • Behavioral: Health-e Kids Control App
    Tablet based health promotion information App
Study Arms  ICMJE
  • Experimental: Intervention: ezParent Program
    Intervention: Behavioral: ezParent Program
  • Active Comparator: Control: Health-e Kids App
    Intervention: Behavioral: Health-e Kids Control App
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2018)
287
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2016)
312
Actual Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02723916
Other Study ID Numbers  ICMJE ORA# 15012705
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Susie Breitenstein, Ohio State University
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rush University Medical Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP