NCT07734545

Brief Summary

The proposed project aims to evaluate the Parenting Young Children Check-up (PYCC) through a randomized clinical trial in a family medicine clinic in Detroit that primarily serves low-income families. Forty parents will be randomized to intervention (n = 20) or control (n = 20) 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
5mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Nov 2025Dec 2026

Study Start

First participant enrolled

November 6, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 24, 2026

Last Update Submit

July 24, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Disruptive Behavior Problems

    Measured with the Eyberg Child Behavior Inventory

    From enrollment (baseline) to follow-up at 1-month and 3-months post baseline

  • Children's Behavioral Health Challenges

    Measured with the Preschool Pediatric Symptoms Checklist

    From enrollment (baseline) to follow-up at 1-month and 3-months post baseline

Secondary Outcomes (2)

  • Parenting Stress

    From enrollment (baseline) to follow-up at 1-month and 3-months post baseline

  • Parenting

    From enrollment (baseline) to follow-up at 1-month and 3-months post baseline

Other Outcomes (2)

  • Use of Modules on the PYCC Website

    From enrollment (baseline) to follow-up at 1-month and 3-months post baseline

  • Satisfaction with the Parenting Young Children Check-up

    From enrollment (baseline) to follow-up at 3-months post baseline

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: The Parenting Young Children Check-up

No Intervention: Control

NO INTERVENTION

This arm will only complete assessment measures.

Interventions

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.

Intervention

Eligibility Criteria

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

You may qualify if:

  • Parent of child ages 2-5 years old
  • Report a score of 9 or higher on the Preschool Pediatric Symptoms Checklist

You may not qualify if:

  • Does not speak/read English
  • Does not have access to a Smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Problem Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild Behavior

Central Study Contacts

Lucy McGoron, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 24, 2026

First Posted

July 29, 2026

Study Start

November 6, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 29, 2026

Record last verified: 2026-07

Locations