Engaging Mental Health Services for Preschoolers at Risk

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT07054554
Status
Recruiting
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Conditions

  • Family Navigation
  • Mental Health Disorder
  • Minoritized Population
  • Preschool Age Children

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NTRI-MH — OTHER
    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 Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Aug 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
106 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Navigate-Train-Referral-Intervention-Mental-Health (NTRI-MH) Satisfaction Questionnaire [ Time Frame: Immediately after intervention and 3 months after intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Brenda Slaughter
[email protected]
513-636-4776
[email protected]
Kelly Kamimura-Nishimura, MD, MS (PRINCIPAL_INVESTIGATOR)
Karen Burkett, PhD (PRINCIPAL_INVESTIGATOR)

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