Engaging Mental Health Services for Preschoolers at Risk

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Unable to read/speak either English or Spanish.

Trial design

Design model

Parallel

Treatments tested in this trial

  • NTRI-MH

    Other intervention

    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.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Intervention (NTRI-MH)Experimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
Immediately after intervention and 3 months after intervention
2

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)

Time frame
Immediately after intervention and 3-months after intervention
3

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)

Time frame
3-months after intervention
4

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)

Time frame
3-months after intervention

Secondary outcomes

Other outcomes

1

Brief Illness Perceptions Questionnaire

This 11-item scale is designed to assess a parent's representation of mental health disorders (e.g. expected time course, consequences, causes, etc.). It has good test-retest reliability as well as concurrent and predictive validity. All of the items, except the causal scale, are rated using a 0 to 10 response scale. For the causal scale, parents list the three most important causal factors in their child's mental health disorder, and responses are grouped into categories (genetic, environmental, behavioral, dietary, etc.) for analysis.

Time frame
Baseline, immediately after intervention, and 3-months after intervention
2

Decisional Conflict Scale

This 16-item validated measure elicits the parent's preference for treatment options and parent perceived sources of decisional conflict about their preferred option. The scale produces a total score with five subscales: 1) informed; 2) values clarity; 3) support; 4) uncertainty; 5) effective decision. Lower scores are desirable, with a range from 0-100.

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

Family Empowerment Scale

The FES is a 12-item scale that assess perceptions and attitudes about family navigator and caregiver roles/responsibilities within their local service systems and their ability to advocate on behalf of their children. Items are scored on a 5-point likert type scale from 1 (Never) to 5 (Very often). The FES assesses three domains, Work (e.g. "I know what to do when problems arise with the families with whom I work"), Children's Services (e.g., "I make sure that professionals understand caregivers' opinions about what services their children need"), and Community (e.g. "I feel I can have a part in improving services for children in my community")

Time frame
Baseline, immediately after intervention, 3-months after intervention
4

Collaborative Skills Questionnaire

The CSQ is a 36-item scale examining key knowledge and skills development related to training modules. It includes six subscales, one for each I2-ART training manual module: (1) Listening, Engagement, and Boundary Settings Skills, (2) Group Management, (3) Priority Setting, (4) Specific Disorders and Their Treatment, (5) Mental Health Services, and (6) School Options. Questions include, "I can talk to parents about our mutual responsibilities in the working relationship" and "I am aware of barriers that parents may face in seeking help for their children and know how to help them overcome those barriers."

Time frame
Baseline, immediately after intervention, 3-months after intervention

Sponsors and contacts

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Children's Hospital Medical Center, Cincinnati

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator