- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07750054
Testing the Impact of the Parenting Young Children Check-up
August 3, 2026 updated by: Lucy (Kathleen) McGoron, Ph.D., Wayne State University
Randomized Clinical Trial of the Parenting Young Children Check-up in Pediatric Primary Care
The proposed project aims to evaluate the Parenting Young Children Check-up (PYCC) through a randomized clinical trial in a pediatric primary care practice in Detroit that primarily serves low-income families.
Fifty parents will be randomized to intervention (n = 25) or control (n = 25) conditions.
We will follow up with parents 1 month and 3-months later to test the impact of the program on children's behavioral health/disruptive behavior problems, parenting, and parenting stress and to examine how much parents in the intervention group make use of and report satisfaction with the PYCC program.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
This study will test three hypotheses.
First, we hypothesize that randomization to the PYCC intervention group, as compared to the control group, will be related to reduced child behavioral health challenges and disruptive behavior problems.
Second, we hypothesize that randomization to the PYCC intervention group, as compared to control, will be related to improved positive parenting and reduced parenting stress.
Third, for parents in the intervention group, we hypothesize there will be high rates of module use on the PYCC website (i.e., >50%).
Finally, for parents in the intervention group, we also hypothesize that there will be high rates of satisfaction with the PYCC overall and with each PYCC module.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lucy McGoron
- Phone Number: 313-664-2500
- Email: Lucy.K.McGoron@wayne.edu
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Wayne Pediatrics
-
Contact:
- Lucy McGoron
- Phone Number: 3138064414
- Email: Lucy.K.McGoron@wayne.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Parent of child ages 2-5 years old
- Report a score of 9 or higher on the Preschool Pediatric Symptoms Checklist
Exclusion Criteria:
- Does not speak/read English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
This arm will go through the initial check-up of the Parenting Young Children Check-up (PYCC), receive text messages from the PYCC, and have access to modules on the PYCC website.
|
The Parenting Young Children Check-up (PYCC) is a technology-based program for parents of young children with challenging behavior.
The PYCC has three components: 1) the initial check-up, 2) text messages, and 3) the parenting program website.
|
|
No Intervention: Control
This arm will only complete assessment measures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Behavioral Health Challenges
Time Frame: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Measured with the Preschool Pediatric Symptoms Checklist
|
From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
|
Disruptive Behavior Problems
Time Frame: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Measured with the Eyberg Behavior Checklist
|
From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting Stress
Time Frame: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Measured with the Parenting Stress Index
|
From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
|
Parenting
Time Frame: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Measured with the Preschool Version of the Alabama Parenting Questionnaire
|
From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use of Modules on the PYCC Website
Time Frame: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Number of modules used
|
From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
|
Satisfaction with the Parenting Young Children Check-up
Time Frame: From enrollment (baseline) to follow-up at 3-months post baseline
|
From enrollment (baseline) to follow-up at 3-months post baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
July 23, 2026
First Submitted That Met QC Criteria
August 3, 2026
First Posted (Actual)
August 6, 2026
Study Record Updates
Last Update Posted (Actual)
August 6, 2026
Last Update Submitted That Met QC Criteria
August 3, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-25-07-7947
- #R2-2025-13_PR-25-933 (Other Grant/Funding Number: The Children's Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All participation will be confidential.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.