Engaging Mental Health Services for Preschoolers at Risk

NCT07054554 | Recruiting DMC

• 2 other identifiers: 1R34MH137224-01R34MH137224
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Keywords

Family Navigation; mental health disorder; Preschool Age Children

Outcome Measures

Primary Outcomes (10)

• Navigate-Train-Referral-Intervention-Mental-Health (NTRI-MH) Satisfaction Questionnaire

  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)

  Immediately after intervention and 3 months after intervention

• System Usability Scale

  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)

  Immediately after intervention and 3-months after intervention

• Family Navigator Activities Checklist

  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)

  3-months after intervention

• Implementation Questionnaire

  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)

  3-months after intervention

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

  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.

  Baseline

• Referrals to mental health services

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

  Immediately after intervention and 3-months after intervention

• Access to mental health services

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

  Baseline, immediately after intervention, and 3-months after intervention

• Parental Stress Scale

  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).

  Baseline, immediately after intervention, and 3-months after intervention

• Engagement and coordination to mental health services

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

  Baseline, after intervention, 3-months after intervention

• Optimization of mental health services

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

  Baseline, immediately after intervention, 3-months after intervention

Other Outcomes (9)

• Brief Illness Perceptions Questionnaire

  Baseline, immediately after intervention, and 3-months after intervention

• Decisional Conflict Scale

  Baseline, immediately after intervention, and 3-months after intervention

• Family Empowerment Scale

  Baseline, immediately after intervention, 3-months after intervention

Study Arms (2)

Intervention (NTRI-MH)

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.

Other: NTRI-MH

Control

NO INTERVENTION

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 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.

Intervention (NTRI-MH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to read/speak either English or Spanish.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Kelly Kamimura-Nishimura, MD, MS

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly Kamimura-Nishimura, MD, MS

CONTACT

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

Karen Burkett, PhD

CONTACT

karen.burkett@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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 Record Dates

• First Submitted: June 2, 2025
• First Posted: July 8, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)