Mental Health Navigation for Youth Mental Health

(FMHN Trial)

Overseen By Juliet Yonek, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-English/Spanish, Impaired caregiver, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a support system called the Family Mental Health Navigator (FMHN) combined with mobile technology to help publicly-insured youth access mental health services. It aims to improve how these young people start and stay in treatment, especially those from racial and ethnic minority groups.

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.

What data supports the effectiveness of the treatment Family-based mental health navigation for youth mental health?

Research suggests that using navigators, who help families find and use mental health services, can improve engagement in mental health care. Studies show that navigators are promising in increasing access to mental health services, especially in settings like primary care, where many children first seek help. ^{1 2 3 4 5}

Is the mental health navigation treatment safe for humans?

In a study involving a patient navigation system for mothers with depression, no adverse events (harmful effects) were reported, suggesting it is generally safe. ^{1 2 5 6 7}

How does the Mental Health Navigation treatment for youth differ from other treatments?

The Mental Health Navigation treatment is unique because it involves navigators who help youth and their families find and access mental health services, addressing barriers to care and improving engagement. This approach is different from traditional treatments as it focuses on guiding families through the mental health system, which is particularly beneficial for those who struggle to access or engage with existing services. ^{2 6 8 9 10}

Research Team

Marina Tolou-Shams, Ph.D

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for English or Spanish-speaking children aged 6-17 who are publicly insured and currently receiving services at San Francisco General Hospital. They must have mobile phone access and an involved caregiver to provide consent. Children without a guardian's consent, non-English/Spanish speakers, or caregivers unable to give informed consent cannot participate.

Inclusion Criteria

I speak English or Spanish.

Are currently receiving services at the San Francisco General Hospital

Are publicly insured

Exclusion Criteria

Caregiver has impairment that would preclude providing informed consent

I do not speak English or Spanish.

Unavailable guardian for consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development and testing of the Family Mental Health Navigator (FMHN) intervention combined with mHealth practices

8-12 weeks

Treatment

Implementation of the FMHN intervention to improve mental health treatment initiation and engagement

6 weeks

Follow-up

Participants are monitored for mental health service initiation and engagement outcomes

12 months

Treatment Details

Interventions

• Family-based mental health navigation
• Standard of care engagement practices

Trial Overview The study is testing a new approach called the Family Mental Health Navigator (FMHN), which uses family-based guidance along with mobile health technology to see if it helps young people start and stick with mental health services more effectively.

Participant Groups

Group I: Family-based mental health navigation Experimental Treatment 1 Intervention

Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

San Francisco General Hospital Foundation

Collaborator

Trials

1

Recruited

150+

Findings from Research

A patient navigation system was successfully implemented in a Head Start preschool setting, with 47 low-income mothers participating and no refusals, indicating high acceptability of the program.

The navigators maintained excellent fidelity to the model, and importantly, there were no adverse events reported, suggesting the intervention is safe for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing the Capacity of Head Start to Engage Mothers with Depression in Treatment. Silverstein, M., Diaz-Linhart, Y., Grote, N., et al.[2022]

Many children with mental health issues are not receiving the help they need, and pediatric primary care clinics could be key places to identify and address these problems early.

Family navigators, who help families navigate the mental health system, show promise in improving engagement in mental health services for children, although more research is needed to fully understand their effectiveness in pediatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Mental Health Engagement From Primary Care: The Potential Role of Family Navigation. Godoy, L., Hodgkinson, S., Robertson, HA., et al.[2020]

Nearly 50% of adolescents experience mental health disorders, but only about half seek treatment, highlighting the need for effective referral systems like the behavioral health (BH) navigation program implemented in a large health system.

Over a 4-year period, the BH navigation program facilitated 4,555 referrals from 290 primary care physicians, with 91% of physicians reporting that the navigation services improved their clinical care, although satisfaction ratings declined over time, indicating ongoing challenges in maintaining positive assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care provider utilization and satisfaction with a health system navigation program for adolescents with behavioral health needs. Yang, Y., Dillon, EC., Li, M., et al.[2020]

Approximately 1.2 million children and youth in Canada face mental health and addiction issues, yet less than 20% receive appropriate treatment, highlighting a significant gap in care that navigation services aim to address.

The proposed research will synthesize evidence on youth mental health navigation to establish comprehensive standards for care, involving a collaborative team that includes researchers and individuals with lived experience, which may enhance the integration and continuity of care for affected youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigation for youth mental health and addictions: protocol for a realist review and synthesis of approaches and practices (The NavMAP standards project). Markoulakis, R., Arora, SRA., Kodeeswaran, S., et al.[2022]

This study is testing a new foster care family navigator (FCFN) model aimed at improving mental health service access and engagement for youth in the child welfare system, with 80 caregiver-youth dyads participating in a randomized controlled trial.

The FCFN model combines in-person navigation with digital health technology to enhance care coordination, and it is hypothesized that this approach will lead to higher rates of mental health treatment initiation and engagement compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Family-Based Mental Health Navigator Intervention for Youth in the Child Welfare System: Protocol for a Randomized Controlled Trial. Tolou-Shams, M., Ramaiya, M., Lara Salas, J., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Harnessing the Capacity of Head Start to Engage Mothers with Depression in Treatment. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Increasing Mental Health Engagement From Primary Care: The Potential Role of Family Navigation. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Primary care provider utilization and satisfaction with a health system navigation program for adolescents with behavioral health needs. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Experiences of pathways to mental health services for young people and their carers: a qualitative meta-synthesis review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Episodes of mental health treatment among a nationally representative sample of children and adolescents. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Navigation for youth mental health and addictions: protocol for a realist review and synthesis of approaches and practices (The NavMAP standards project). [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Perspectives of Parents and Providers on Reasons for Mental Health Readmissions: A Content Analysis Study. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Connecting youth with health services: Systematic review. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Key attributes of integrated community-based youth service hubs for mental health: a scoping review. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

A Family-Based Mental Health Navigator Intervention for Youth in the Child Welfare System: Protocol for a Randomized Controlled Trial. [2023]