Mental HealthFCFNNCT04506437
Foster Care Mental Health Family Navigator
A study testing Family-based mental health navigation in people with Mental Health, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study will focus on developing and testing a family-based mental health navigator intervention, the Foster Care Family Navigator (FCFN), to evaluate whether the intervention combined with mHealth would be efficacious in improving mental health service initiation and engagement for child welfare-involved youth. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Mental Health
- What is being tested?
- Family-based mental health navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2020to 1 Apr 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- English-speaking youth
- Ages 12-17
- Have an active dependency petition with the SF Unified Family Court (newly filed or existing when the trial starts)
- Are open to SF DPH Foster Care Mental Health Clinic services
- Have an involved caregiver/legal guardian for consent
- Family has mobile phone access
Who cannot join
- Youth is not English-speaking
- Caregiver has impairment that would preclude providing informed consent
- Unavailable guardian for consent
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, 94131
About this study
This study will focus on developing and testing a family-based mental health navigator intervention, the Foster Care Family Navigator (FCFN), to evaluate whether the intervention combined with mHealth would be efficacious in improving mental health service initiation and engagement for child welfare-involved youth.
Read the 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 child welfare-involved (CWI) youth. CWI 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 Foster Care Family Navigator (FCFN), a natural fit for improving CWI youth mental health service and clinical outcomes. The study will start with identifying the feasibility and acceptability of the FCFN intervention. Then, the study will determine whether the FCFN intervention improves CWI youth mental health treatment initiation and engagement, relative to standard of care (case management). 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 FCFN model.
- Conditions
- Mental Health
- Being tested
- Family-based mental health navigation, Standard of Care (Clinic Case Management)
- Keywords
- Adolescent, Foster Care, Mental Health, Navigator, Service Access
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based mental health navigationBehavioural
Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
Standard of Care (Clinic Case Management)Behavioural
Standard of care case management practices and services-as-usual
| Study group | Role | What they receive |
|---|---|---|
| Family-based mental health navigation | Experimental | Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement Receives: Behavioral: Family-based mental health navigation |
| Standard of Care (Clinic Case Management) | Active comparator | Standard of care case management practices and services-as-usual Receives: Behavioral: Standard of Care (Clinic Case Management) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Treatment Referral
Number of days until treatment referral is made
Measured: 12 months post enrollment
Time to Treatment Initiation
Number of days until attendance at first treatment session
Measured: 12 months post enrollment
Treatment Engagement: Number of Participants in Treatment for 6 or More Weeks
Engagement as measured by attendance in treatment for 6 or more weeks
Measured: 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start20 Aug 2020
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial design in which the investigators will test a theory-driven family-based navigator treatment engagement intervention (FCFN) while also collecting data on the FCFN model's potential implementation and adoption within child welfare and behavioral health settings.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Marina Tolou-Shams, Ph.D, Principal investigator, UC San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506437
- Sponsor's protocol ID
- 1R34MH119433-01A1
- Other IDs
- 1R34MH119433-01A1
- Acronym
- FCFN
- Status last verified
- Jun 2026
- First submitted
- 6 Aug 2020
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tolou-Shams M, Ramaiya M, Lara Salas J, Ezimora I, Shumway M, Duerr Berrick J, Aguilera A, Borsari B, Dauria E, Friedling N, Holmes C, Grandi A. A Family-Based Mental Health Navigator Intervention for Youth in the Child Welfare System: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 12;12:e49999. doi: 10.2196/49999.
PubMed 37698896