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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new program, which combines family support with mobile health tools, can help young people initiate and maintain mental health services. It focuses on tailoring support for families to better navigate mental health care. The trial seeks English or Spanish-speaking children aged 6-17 who are publicly insured and currently receiving services at San Francisco General Hospital, with a caregiver able to provide consent. Families with access to a mobile phone and meeting these criteria may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health solutions for families.

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 prior data suggests that the Family Mental Health Navigator is safe for youth mental health?

Research has shown that family-based mental health navigation programs are generally well-received. Current studies report no major negative effects from these programs. For example, one study highlighted how these services help families find the right mental health support without mentioning any safety concerns, suggesting the approach is safe. The focus on improving access to mental health services through family guidance and digital tools involves no risky procedures or medications, making it a low-risk option for participants. While specific safety data for the Family Mental Health Navigator is limited, the absence of negative effects in related studies suggests it is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard mental health treatments for youth, which often focus solely on medication or individual therapy, the family-based mental health navigation approach combines family support with mobile health (mHealth) tools to enhance treatment initiation and engagement. This method provides a more holistic approach by involving family members directly in the care process, which can lead to better support and understanding. Additionally, the use of mHealth practices ensures that help is more accessible and tailored to the needs of young people, potentially improving adherence and outcomes compared to traditional methods. Researchers are excited about this because it could lead to faster, more sustainable improvements in youth mental health.

What evidence suggests that the Family Mental Health Navigator is effective for improving mental health service initiation and engagement for youth?

Research shows that helping families navigate mental health services can improve how young people use these services. Past studies have found family navigator programs promising in encouraging more young people to start and continue mental health treatment. In this trial, participants will receive family-based mental health navigation, which combines navigator intervention with mobile health technology (mHealth) to enhance treatment initiation and engagement. The main idea is to guide families through the mental health system, simplifying access to necessary help. Early results suggest that combining these navigation services with mHealth increases their effectiveness. This approach aims to assist families in beginning and maintaining treatment, particularly for young people with public health insurance. ^{1 3 6 7 8}

Who Is on the Research Team?

Marina Tolou-Shams, Ph.D

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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

Are currently receiving services at the San Francisco General Hospital

Are publicly insured

I am between 6 and 17 years old.

Exclusion Criteria

Caregiver has impairment that would preclude providing informed consent

Unavailable guardian for consent

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10523219/

A Family-Based Mental Health Navigator Intervention for ... This study aims to develop and test a foster care family navigator (FCFN) model to improve mental health service outcomes for CWI adolescents (aged 12-17 years ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04822636?term=%22mental+health%22&recrs=abc&draw=2&rank=2

Family Mental Health Family Navigator Project (FMHN) The study will demonstrate how a family-based navigator intervention combined with mHealth may lead to improved mental health treatment initiation and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7595253/

Family and Youth Mental Health Needs and Outcomes in a ... This study examines trends regarding clients of a family navigation service in Toronto, Canada, which supports families of youth ages 13–26 with MHA concerns.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949923224000424

The role of navigation services in supporting mental health ... This is a descriptive qualitative study of TAY, family, and provider perspectives on the role of navigation as it pertains to transitions in care for TAY with ...

5. withpower.com withpower.com/trial/phase-2022-b49e3

Mental Health Navigation for Youth Mental Health (FMHN Trial) This trial tests a support system called the Family Mental Health Navigator (FMHN) combined with mobile technology to help publicly-insured youth access ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11619757/

Development of an Emergency Department Family ... Youth with SSIB seen in the Emergency Department (ED) are often discharged to the community, yet less than 40% receive subsequent mental health ...

7. formative.jmir.org formative.jmir.org/2024/1/e48945

Designing a Web-Based Navigation Tool to Support Access to ... This study aims to investigate young person and parent or caregiver views on the design, content, functioning, and user experience of a web-based mental health ...

8. researchprotocols.org researchprotocols.org/2023/1/e49999/

A Family-Based Mental Health Navigator Intervention for ... This study aims to develop and test a foster care family navigator (FCFN) model to improve mental health service outcomes for CWI adolescents (aged 12-17 years ...