Recruiting

NTRI-MH

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07054554

Conditions

Mental Health Disorder

Family Navigation

Minoritized Population

Preschool Age Children

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NTRI-MH

Study Details

Brief summary:

Most mental health (MH) disorders develop in early childhood but are not clinically identified or treated until later-delaying treatment services that could prevent the enduring effects of long-term MH problems. Moreover, low income, ethno-racial minoritized children who exhibit higher rates of persistent MH disorders, are at greater risk for lags in identification and treatment. Head Start (HStart) has shown early school success for low-income children, aged 3-5 years, who are disproportionately Black or Latinx. HStart monitors early childhood MH symptoms, yet studies have found that when detected, only those most impaired are referred for treatment. In our research, the investigators learned that system and individual level barriers preclude early treatment among HStart preschoolers with developmental concern. The investigators showed that caregivers encountered system barriers of HStart teachers and primary care providers (PCPs) falling behind in referrals for intervention, and caregiver beliefs about stigma, their limited knowledge and distrust of healthcare hindered early engagement in services. Studies on MH treatment obstacles for low-income, ethno-racial minoritized people illustrate similar barriers to those found among HStart preschoolers with developmental concern. We developed and tested an ethno-racially matched, peer-based family navigator program for HStart preschoolers with developmental concern. Navigators used trust and empowerment to increase caregiver advocacy thereby leading to improved professional alliances and treatment. A navigator program for those with primary MH concerns has not been trialed. For Aim 1, the investigators aim to tailor and trial in a case series the Navigate-Train-Referral-Intervention Mental Health (NTRI-MH) intervention to promote access, engagement, coordination, and optimization of services for preschoolers with MH symptoms. The investigators have used focus group feedback from caregiver, navigator, HStart teacher, and PCP stakeholders to adapt NTRI-MH and created a web-based dashboard to monitor outcomes (Phase 1). Then, for phase 2, the investigators will conduct a feasibility study for caregivers of HStart preschoolers with MH symptoms, guided by ethno-racially matched family navigators and referrals by HStart teachers and PCPs (n=20). Further, for Aim 2, the investigators will pilot test NTRI-MH for caregivers of preschoolers with MH symptoms compared to an active control group of caregivers who receive child behavior training (n=86). The investigators will trial the effectiveness of the NTRI-MH mechanisms of caregiver beliefs on MH, empowerment, and professional alliances on family functioning and child emotion regulation. If the aims of the project are achieved, this study would have a large impact on early MH service use for ethno-racial minoritized young children with the potential to improve child MH outcomes.

Conditions

Mental Health Disorder

Family Navigation

Minoritized Population

Preschool Age Children

Study ID

NCT07054554

Start date

Jul 1, 2025

Status verified date

Aug, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention (NTRI-MH)

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.

no intervention: Control

The caregivers in the active control group will receive a 2-hour training seminar and educational materials including handouts/videos from a developmental activities' toolkit pertinent to the emotional, behavioral, and developmental age of their child. The training seminar will include topics of common MH concerns of young children, steps to addressing challenging behavior, strategies for decreasing problems behaviors, and crisis management.

Interventions

NTRI-MH

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.

Primary outcome measure

  • Navigate-Train-Referral-Intervention-Mental-Health (NTRI-MH) Satisfaction Questionnaire [ Time Frame: Immediately after intervention and 3 months after intervention ]
  • System Usability Scale [ Time Frame: Immediately after intervention and 3-months after intervention ]
  • Family Navigator Activities Checklist [ Time Frame: 3-months after intervention ]
  • Implementation Questionnaire [ Time Frame: 3-months after intervention ]
  • Referrals to Primary Care Providers (PCPs) and mental health services [ Time Frame: Baseline ]
  • Referrals to mental health services [ Time Frame: Immediately after intervention and 3-months after intervention ]
  • Access to mental health services [ Time Frame: Baseline, immediately after intervention, and 3-months after intervention ]
  • Parental Stress Scale [ Time Frame: Baseline, immediately after intervention, and 3-months after intervention ]
  • Engagement and coordination to mental health services [ Time Frame: Baseline, after intervention, 3-months after intervention ]
  • Optimization of mental health services [ Time Frame: Baseline, immediately after intervention, 3-months after intervention ]

Central Contacts and Locations

Central contacts

Kelly Kamimura-Nishimura, MD, MS

513-636-7594kelly.kamimura-nishimura@cchmc.org

Karen Burkett, PhD

karen.burkett@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Principal Investigator:

Kelly Kamimura-Nishimura, MD, MS

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Aug 24, 2025

Last verified

Aug, 2025

Keywords

  • Family Navigation
  • mental health disorder
  • Preschool Age Children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-08-24.