RecruitingNot ApplicableNCT07054554

Engaging Mental Health Services for Preschoolers at Risk


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

106 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and testing a navigator-based program to help caregivers of preschool-aged children in Head Start programs access mental health services more effectively, particularly for Black and Latino families who face greater barriers to care. Trained family navigators work alongside caregivers, teachers, and pediatricians to reduce stigma, build trust, and connect children showing early mental health concerns to appropriate treatment. Eligible participants include caregivers of Head Start children aged 3 to 5 who have been flagged for potential mental health concerns, as well as teachers, navigators, and pediatricians involved in their care. Participation involves attending navigation meetings, completing questionnaires, and following up over a 6-to-9-month period. This summary was prepared using AI to help patients understand this research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNTRI-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.


Locations(1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

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NCT07054554


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