Family Mental Health Family Navigator Project (FMHN) (FMHN)
August 6, 2026 updated by: University of California, San Francisco
Family Mental Health Family Navigator
This study will focus on developing and testing a family-based mental health navigator intervention, the Family Mental Health Navigator (FMHN), to evaluate whether the intervention combined with mHealth is preliminary efficacious in improving mental health service initiation and engagement for publicly-insured youth.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study will demonstrate how a family-based navigator intervention combined with mHealth may lead to improved mental health treatment initiation and engagement among publicly-insured youth.
Publicly-insured youth have high rates of mental health symptoms relative to youth in the community, and are disproportionately racial and ethnic minorities, only perpetuating disparities in this population's mental health access and engagement.
The proposed project will develop and test a family-based navigator intervention, the Family Mental Health Navigator (FMHN), a natural fit for improving publicly-insured youth's mental health service and clinical outcomes.
The study will start with identifying the feasibility and acceptability of the FMHN intervention.
Then, the study will determine whether the FMHN intervention improves publicly-insured youth mental health treatment initiation and engagement.
Finally, the study will characterize patterns of pre- and post-service outcomes along the behavioral health services cascade of care, to further evaluate the feasibility, acceptability, and preliminary impact of the FMHN model.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94131
- UCSF Zuckerberg San Francisco General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- English-speaking and/or Spanish-speaking youth
- Ages 6-17
- Are currently receiving services at the San Francisco General Hospital
- Are publicly insured
- Have an involved caregiver/legal guardian for consent
- Family has mobile phone access
Exclusion Criteria:
- Youth is not English-speaking nor Spanish-speaking
- Caregiver has impairment that would preclude providing informed consent
- Unavailable guardian for consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Family-based mental health navigation
Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
|
Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to treatment referral
Time Frame: 12 months post enrollment
|
Number of days until treatment referral is made
|
12 months post enrollment
|
|
Time to treatment initiation
Time Frame: 12 months post enrollment
|
Number of days until attendance at first treatment session
|
12 months post enrollment
|
|
Treatment engagement
Time Frame: 12 months post enrollment
|
Engagement as measured by attendance in treatment for 6 or more weeks
|
12 months post enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marina Tolou-Shams, Ph.D, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2022
Primary Completion (Actual)
November 1, 2025
Study Completion (Actual)
December 1, 2025
Study Registration Dates
First Submitted
March 25, 2021
First Submitted That Met QC Criteria
March 25, 2021
First Posted (Actual)
March 30, 2021
Study Record Updates
Last Update Posted (Actual)
August 11, 2026
Last Update Submitted That Met QC Criteria
August 6, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1929675
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.