Recruiting
NTRI-MH

Mental Health Services Engagement for At-Risk Preschoolers

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Study AimThis 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, 2025Actual 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 
NCT070545541R34MH137224-01
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf 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.

NTRI-MH intervention will use evidence-based instructional strategies for adult professional development (i.e., lecture, discussion, case studies, role-playing). NTRI-MH training includes 20 hours of didactic and interactive sessions (5 sessions of 4 hours each) covering the following areas specific to MH needs in young children at-risk: 1) benefits and barriers (professional and family) to early intervention for children with MH concerns, 2) approaches for empowering caregivers, 3) supporting strategies to assist families through early MH access and service engagement , 4) use of the dashboard to track and monitor the course of clinical, functional, and behavioral outcomes, 5) evidence-based working alliances with PCPs and teachers (including a 2 hour session with the child's teacher), and 6) MH resources, treatments and services, and strategies to support parental management of young child behaviors.
Study Objectives
Primary Objectives

The implementation questionnaire will include 12-Likert score items recording information about acceptability, intervention appropriateness and feasibility of the intervention. Score range: 12-60 (the higher the score, better acceptability, feasibility, and appropriateness)

This is a 7-item Likert scale questionnaire that elicits caregivers' and family navigators' opinions regarding the format, content, length, and convenience of the intervention. Score Range: 7-28 (the higher the score, better satisfaction)

The SUS is a 10-item Likert scale questionnaire that elicits family navigators', teachers', and PCPs' global views of the NTRI-MH treatment manual's usability. Score range: 0-100 (the higher the score, better usability)

This 29-item checklist will document family navigator-caregiver activities, including emotional support, action planning, information provision, advocacy, and skill development. Range 0-29 (the higher the score, more activities completed)

We will obtain data regarding referrals made to PCPs and/or mental health services by Head Start teachers though reviewing the ChildPlus Head Start Database.

We will obtain data regarding referrals to mental health services by Primary Care Providers (PCPs) through medical chart review.

Using a web-based electronic dashboard, user-friendly system, we will record the number of referrals to mental health services.

This is an 18-item self-report measure in which parents respond to statements about their typical relationship with their child. This measure will assess parents' feelings about positive aspects (e.g., emotional benefits, personal development) and negative views of parenting (e.g., demands on resources, feelings of stress). The possible range of PSS is 18 (low stress) to 90 (high stress).

Using a web-based electronic dashboard, we will record the alignment with mental health recommendations.

Using a web-based, electronic dashboard, we will record the caregiver agreement with goals and tasks.

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 CenterCincinnati, United StatesSee the location
Recruiting
One Study Center
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