Recruiting

NTRI-MHMental Health Services Engagement for At-Risk Preschoolers

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Study Aim

This clinical trial aims to evaluate the Navigate-Train-Referral-Intervention-Mental-Health (NTRI-MH) program, focusing on participants' satisfaction, usability, and implementation. It also measures the impact on referrals, access to mental health services, and parental stress.

What is being tested

NTRI-MH

Other
Who is being recruted

Mental Disorders

Over 18 Years
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorChildren's Hospital Medical Center, Cincinnati
Study ContactKelly Kamimura-Nishimura, MD, MSMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2025

Actual date on which the first participant was enrolled.

The study is focused on improving mental health services for young children who are at risk of developing mental health issues. It aims to identify what helps or hinders families from accessing these services and to improve a program called NTRI-MH, designed to better support these families. This research involves different caregivers, teachers, and healthcare professionals to understand and address the challenges faced by families. By enhancing the service delivery and creating an easy-to-use online system to track progress, the study seeks to ensure that children receive the right support at the right time, which is crucial for their long-term well-being. Participants in this study include caregivers, navigators, teachers, and primary care providers (PCPs) who will undergo specific training to support families more effectively. The study uses focus groups, web-based tools, and hands-on training sessions to gather information and improve the NTRI-MH program. Families will be monitored through a secure online dashboard that tracks their use of services and the child's mental health symptoms over time. This comprehensive approach aims to better coordinate care, improve service engagement, and ultimately enhance the mental and emotional health of at-risk preschoolers.

Official TitleEngaging Mental Health Services for Preschoolers at Risk 
Principal SponsorChildren's Hospital Medical Center, Cincinnati
Study ContactKelly Kamimura-Nishimura, MD, MSMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

106 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental Disorders

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
For the intervention group, the navigators will implement the NTRI-MH for 6 months with the caregivers, including 15 hours of navigation services with a 2-hour face-to-face meeting, at least 3 monthly in-person meetings, attending assessments and treatments with the caregivers at HStart, PCP offices, and MH services locations. After these visits, the navigator will follow up by phone, text, or email with the caregiver. Navigators will meet weekly with research staff for supervision and case review. Teachers will share a copy of screenings and recommend a visit with PCP, and PCPs will review the Just-In-Time packet and make referrals.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Cincinnati Children's Hospital Medical Center

Cincinnati, United StatesSee the location
Recruiting
One Study Center