NCT02723916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 31, 2020

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

3.8 years

First QC Date

January 21, 2016

Results QC Date

August 27, 2020

Last Update Submit

December 6, 2020

Conditions

Keywords

ParentsChildPreschooleHealth

Outcome Measures

Primary Outcomes (1)

  • Parenting Behaviors

    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 Outcomes (5)

  • Change in Parent Behaviors

    T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

  • Change in Child Behavior Problems

    T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

  • Change in Child Externalizing Behavior Problems

    T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

  • Change in Parenting Stress

    T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

  • Change in Parenting Self-efficacy

    T1 = baseline; T2 = 3-months post baseline; T3 = 6-months post baseline; T4 = 12-months post baseline.

Study Arms (2)

Intervention: ezParent Program

EXPERIMENTAL
Behavioral: ezParent Program

Control: Health-e Kids App

ACTIVE COMPARATOR
Behavioral: Health-e Kids Control App

Interventions

Tablet-based behavioral parent training program.

Also known as: previously called eCPP
Intervention: ezParent Program

Tablet based health promotion information App

Control: Health-e Kids App

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Only one parent per family
  • Parent previously used the ezPARENT program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (4)

  • 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.

    PMID: 27592122BACKGROUND
  • 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.

  • 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.

  • 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.

Limitations and Caveats

No specific limitations related to the conduct of the study to report.

Results Point of Contact

Title
Dr. Susie Breitenstein
Organization
The Ohio State University, College of Nursing

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 21, 2016

First Posted

March 31, 2016

Study Start

September 1, 2015

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

December 31, 2020

Results First Posted

December 31, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations