NTRI-MH for Mental Health Disorders

(NTRI-MH Trial)

Overseen By Kelly Kamimura-Nishimura, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Unable to read/speak English or Spanish

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

106 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called NTRI-MH, designed to improve access to mental health care for young children at risk. The program pairs caregivers with family navigators trained to help them find and use mental health services effectively. It focuses on preschoolers in the Head Start program who show signs of potential mental health issues. This trial may suit caregivers of Head Start preschoolers at risk for mental health disorders who seek support in navigating the healthcare system. As an unphased trial, it offers caregivers a unique opportunity to contribute to innovative solutions for early childhood mental health care.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the NTRI-MH intervention is safe for preschoolers with mental health symptoms?

Research has shown that the NTRI-MH program is designed to assist caregivers of young children who may be at risk for mental health issues. The program employs family navigators to connect caregivers with mental health support for their children. While specific studies on the safety of NTRI-MH are lacking, its focus on guidance and support, rather than medication or medical procedures, suggests a lower risk of side effects.

As a social support program, not a medical one, safety concerns are minimal. The program aims to enhance how families access mental health services. It involves meetings and communication with caregivers, which are generally manageable. Feedback from caregivers, teachers, and primary care providers has shaped the program, ensuring it meets participants' needs effectively and safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NTRI-MH trial because it offers a hands-on, personalized approach to supporting caregivers of children with mental health disorders, which is different from typical treatments like medication or traditional therapy. Unlike standard options, NTRI-MH involves navigators who work closely with caregivers over six months, providing navigation services and direct support in real-life settings like home, schools, and doctor visits. This approach not only aims to help caregivers effectively manage their child's mental health challenges but also provides tailored guidance and follow-up, potentially leading to more significant improvements in the caregivers' ability to address their child's needs.

What evidence suggests that the NTRI-MH intervention is effective for mental health disorders in preschoolers?

Research has shown that the NTRI-MH program, which participants in this trial may receive, might assist preschoolers with mental health issues, particularly those from low-income, minority backgrounds. Early results suggest that family navigators—individuals who help families understand and access healthcare—can change caregivers' perceptions of mental health and encourage them to seek necessary help. This support can enhance relationships with professionals and improve family collaboration. Although specific data on the effectiveness of NTRI-MH is not yet available, these program components aim to overcome barriers to early mental health care, potentially leading to better outcomes for children. ^{1 6 7 8 9}

Who Is on the Research Team?

Kelly Kamimura-Nishimura, MD, MS

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for caregivers of preschoolers aged 3-5 years, likely from low-income Black or Latinx backgrounds. These children are at risk for mental health disorders and may be part of the Head Start program. The study seeks participants who face barriers to accessing mental health services due to systemic issues or personal beliefs.

Inclusion Criteria

Caregivers: Current caregiver of an HStart preschooler at-risk for mental health disorders (ASQ-SE above threshold score)

I am a current Head Start teacher, over 18, from one of the 2 sites.

I am over 18, identify as Latinx, Black, or White, and have experience as a family navigator or community health worker.

Exclusion Criteria

Unable to read/speak either English or Spanish

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Groups

Conduct focus groups to elucidate barriers and facilitators to access and engagement of HStart children in MH services

6 weeks

6 focus group sessions (virtual)

NTRI-MH Training and Implementation

Training for navigators and teachers followed by implementation of the NTRI-MH intervention with caregivers

3 months

5 training sessions (in-person), 3 monthly in-person meetings

Pilot Testing

Pilot test NTRI-MH for caregivers of preschoolers with MH symptoms compared to an active control group

6 months

6 monthly in-person meetings

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NTRI-MH

Trial Overview The NTRI-MH intervention is being tested, which aims to improve access and engagement in mental health services through a family navigator program. This includes a web-based dashboard for monitoring outcomes and involves ethno-racially matched navigators guiding caregivers.

How Is the Trial Designed?

Group I: Intervention (NTRI-MH) Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 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.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07054554

Engaging Mental Health Services for Preschoolers at Risk The investigators will trial the effectiveness of the NTRI-MH mechanisms of caregiver beliefs on MH, empowerment, and professional alliances on family ...

2. reporter.nih.gov reporter.nih.gov/project-details/10951843

Engaging Mental Health Services for Preschoolers at Risk We will trial the effectiveness of the NTRI-MH mechanisms of caregiver beliefs on MH, empowerment, and professional alliances on family functioning and child ...

3. patlynk.com patlynk.com/trial/NCT07054554

Mental Health Services Engagement for At-Risk Preschoolers The study is focused on improving mental health services for young children who are at risk of developing mental health issues.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10786006/

The social determinants of mental health and disorder In this paper we provide a roadmap to address the social determinants that cause mental ill health.

5. who.int who.int/news-room/fact-sheets/detail/mental-health-strengthening-our-response

Mental health WHO fact sheet on mental health providing key facts and information on determinants, strategies and interventions, WHO response.

6. nimh.nih.gov nimh.nih.gov/health/statistics/mental-illness

Mental Illness - National Institute of Mental Health (NIMH) - NIH An overview of statistics for mental illnesses. Mental illnesses are common in the United States. One in six U.S. adults lives with a mental illness (43.4 ...

7. usa.edu usa.edu/blog/mental-health-statistics/

Mental Health Statistics [2024] | USAHS The NIH estimates that over 57 million Americans live with a mental illness. Learn more details about U.S. mental health statistics here.

8. eohhs.ri.gov eohhs.ri.gov/sites/g/files/xkgbur226/files/2021-06/Rhode_Island_Final_Behavioral_Health_Supply_Report.pdf

Rhode Island Behavioral Health Project: Supply Report Rhode Island ranked lowest of all New England states for other behavioral health counselors and second lowest for substance abuse counselors, though other types ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0277953625008135

Parental employment quality during childhood and mental ... Socioeconomic conditions play an important role in shaping the mental health outcomes of children and youth. Socioeconomic disadvantage in early life is ...