Behavioral HealthEarly Phase 1NCT07750054
Testing the Impact of the Parenting Young Children Check-up
A Early Phase 1 study testing Parenting Young Children Check-up in people with Behavioral Health and Disruptive Behaviors, run by Wayne State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavioral Health, Disruptive Behaviors, Parenting Behavior
- What is being tested?
- Parenting Young Children Check-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parent of child ages 2-5 years old
- Report a score of 9 or higher on the Preschool Pediatric Symptoms Checklist
Who cannot join
- Does not speak/read English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wayne Pediatrics
Detroit, Michigan, 48202
Lucy McGoron, 3138064414, Lucy.K.McGoron@wayne.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Parenting Young Children Check-up
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting Young Children Check-upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Parenting Young Children Check-up |
| Control | No intervention | This arm will only complete assessment measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disruptive Behavior Problems
Measured with the Eyberg Behavior Checklist
Measured: 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
Measured: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
Secondary outcomes (2)
Parenting Stress
Measured with the Parenting Stress Index
Measured: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
Parenting
Measured with the Preschool Version of the Alabama Parenting Questionnaire
Measured: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucy (Kathleen) McGoron, Ph.D., Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750054
- Sponsor's protocol ID
- IRB-25-07-7947
- Other IDs
- #R2-2025-13_PR-25-933
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participation will be confidential.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of the Parenting Young Children Check-up in Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT07750054
- Acronym / sponsor ID
- IRB-25-07-7947
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Parenting Young Children Check-upThis 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. |
| Control | No intervention | –This arm will only complete assessment measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parent of child ages 2-5 years old
- Report a score of 9 or higher on the Preschool Pediatric Symptoms Checklist
Key exclusion criteria (1 listed)
- Does not speak/read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenting Young Children Check-upThe 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. | Behavioural | Intervention |
Primary outcome
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
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
2 secondary outcomes
Parenting Stress
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No. All participation will be confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Parenting Young Children Check-up in people with Behavioral Health and Disruptive Behaviors, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucy McGoron (313-664-2500, Lucy.K.McGoron@wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disruptive Behavior Problems (time frame: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.