Engaging Mental Health Services for Preschoolers at Risk
Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Jun 27, 2025
Trial Information
Current as of July 12, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new way to help young children, ages 3 to 5, who show early signs of mental health challenges. Many children from low-income families, especially those who are Black or Latinx, face delays in getting the support they need. This study focuses on preschoolers enrolled in Head Start, a program that supports early learning. The researchers are testing a special program called NTRI-MH, where trained family navigators—people who share similar backgrounds with the families—work closely with caregivers to guide them through mental health services. These navigators help families feel more confident and connected to teachers and doctors, aiming to get children the right help sooner.
Caregivers of Head Start preschoolers who show signs of possible mental health concerns may be eligible to participate, along with Head Start teachers, doctors who care for these children, and experienced family navigators. Participants will be part of a program that includes support from family navigators, referrals by teachers and doctors, and tools to track how children are doing. The study will compare this new approach to more traditional child behavior training to see which works better. If successful, this program could make it easier for families in underserved communities to access mental health care early, improving children’s well-being as they grow. The trial has not started recruiting yet, but families who speak English or Spanish and meet the criteria might be invited to join.
Gender
ALL
Eligibility 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.
About Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center in Cincinnati is a leading pediatric healthcare institution dedicated to advancing child health through innovative clinical research and comprehensive patient care. Renowned for its commitment to excellence, the center conducts a wide range of clinical trials aimed at developing and evaluating new treatments and therapies for pediatric populations. With a focus on multidisciplinary collaboration and ethical research practices, Children's Hospital Medical Center strives to improve health outcomes for children while contributing to the broader scientific understanding of pediatric medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cincinnati, Ohio, United States
Patients applied
Trial Officials
Kelly Kamimura-Nishimura, MD, MS
Principal Investigator
Children's Hospital Medical Center, Cincinnati
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported