Helping Head Start preschoolers at risk connect with mental health services.
Official title: Engaging Mental Health Services for Preschoolers at Risk
Run by Children's Hospital Medical Center, Cincinnati · NCT07054554 · Data updated 2026-11-12
This project will try family navigation plus a web dashboard to see if they help caregivers of Head Start preschoolers (ages 3–5) at risk for mental health disorders get mental health support sooner.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 106 (estimated) |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT07054554 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are caregivers of Head Start preschoolers aged about 3–5 who screen at-risk for mental health concerns (ASQ-SE above threshold), plus family navigators, Head Start teachers, and primary care providers who work with these children and can read/speak English or Spanish and are 18 or older.
✕Probably not a fit
Families who are not enrolled in Head Start, who cannot participate in English or Spanish, or who already have timely, effective mental health care in place are less likely to benefit from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The project uses a phased approach beginning with stakeholder focus groups (caregivers, family navigators, Head Start teachers, and primary care providers) conducted in English or Spanish via a web platform to identify barriers and facilitators to early mental health care. Findings will guide enrichment of a family navigation program and development of a web-based dashboard to track clinical, functional, and behavioral outcomes. Focus groups will be recorded, transcribed verbatim, and analyzed alongside demographic data to inform design. Subsequent phases will pilot the enriched navigation and dashboard within local Head Start sites and refine the tools based on user feedback.
Why it matters
Potential benefit: If successful, this approach could help preschoolers get mental health care earlier and reduce long-term problems from untreated symptoms.
How similar studies have gone: Family navigation and school-based screening have shown promise in improving access to care in other settings, but combining an enriched navigator program with a web-based dashboard for Head Start preschoolers is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Family Navigators: Having experience working as family navigator and/or community health worker; Latinx, Black or White; \> 18 years old. * Caregivers: current caregiver of a HStart preschooler at-risk for MH disorders (ASQ-SE above threshold score) * Teachers: Current Head Start (HStart) teacher from one of the 2 HStart site;\> 18 years old; Any race/ethnicity. * PCPs: Currently providing primary care for HStart preschool age children at risk for MH disorders; \> 18 years old; Any race/ethnicity. Exclusion Criteria: * Unable to read/speak either English or Spanish.
Where it's running
-
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States Recruiting
Study contacts
- Principal investigator: Kelly Kamimura-Nishimura, MD, MS — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Kelly Kamimura-Nishimura, MD, MS
- Email: kelly.kamimura-nishimura@cchmc.org
- Phone: 513-636-7594
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.