Engaging Mental Health Services for Preschoolers at Risk

This study is testing an intervention called NTRI-MH to help connect young children (ages 3-5) at risk for mental health disorders with services. Many mental health issues start early but aren't treated until later, especially for children from low-income or minority backgrounds. NTRI-MH is a training program for family navigators, caregivers, and teachers to improve how they identify and refer children in Head Start programs for mental health support. The study will look at how satisfied people are with NTRI-MH and how easy it is to use, as well as the activities of family navigators. You could be a family navigator, a caregiver of a Head Start preschooler at risk, or a Head Start teacher to participate. The current status of the study is unclear.

Study design
This interventional study plans to enroll 106 participants, including family navigators, caregivers, and teachers. It involves focus groups and an intervention called NTRI-MH.
What's involved
The NTRI-MH training includes 20 hours of didactic and interactive sessions, spread over 5 sessions of 4 hours each. Focus groups will also be held via a web-based platform.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed immediately after the intervention and again 3 months later to assess satisfaction and usability.

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NCT07054554

Engaging Mental Health Services for Preschoolers at Risk

Recruiting
NAAges 18+InterventionalHealth services
Children's Hospital Medical Center, Cincinnati
~106 participants
Updated 2025-08-24 on ClinicalTrials.gov
What's tested:NTRI-MH

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Navigate-Train-Referral-Intervention-Mental-Health (NTRI-MH) Satisfaction Questionnaire
Measured over Immediately after intervention and 3 months after intervention
+9 more outcomes measured
Mental Health Disorder
Family Navigation
Minoritized Population
Preschool Age Children
1 sites across 1 states
Ohio1
  • Kelly Kamimura-Nishimura, MD, MS · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

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Eligibility criteria

Inclusion

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

Unable to read/speak either English or Spanish.
  • Navigate-Train-Referral-Intervention-Mental-Health (NTRI-MH) Satisfaction QuestionnaireImmediately after intervention and 3 months after intervention

    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)

  • System Usability ScaleImmediately after intervention and 3-months after intervention

    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)

  • Family Navigator Activities Checklist3-months after intervention

    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)

  • Implementation Questionnaire3-months after intervention

    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)

  • Referrals to Primary Care Providers (PCPs) and mental health servicesBaseline

    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.

  • Referrals to mental health servicesImmediately after intervention and 3-months after intervention

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

  • Access to mental health servicesBaseline, immediately after intervention, and 3-months after intervention

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

  • Parental Stress ScaleBaseline, immediately after intervention, and 3-months after intervention

    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).

  • Engagement and coordination to mental health servicesBaseline, after intervention, 3-months after intervention

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

  • Optimization of mental health servicesBaseline, immediately after intervention, 3-months after intervention

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