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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Other trials in United States

About this study

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 groups in NCT04506437
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.

20 Aug 20201 Apr 2025

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Foster Care Mental Health Family Navigator
ClinicalTrials.gov ID: NCT04506437
Acronym / sponsor ID: FCFN / 1R34MH119433-01A1
Conditions: Mental Health
Keywords: Adolescent, Foster Care, Mental Health, Navigator, Service Access
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 20 Aug 2020 (actual)
Primary completion: 1 Apr 2025 (actual)
Study completion: 1 Apr 2025 (actual)
First posted: 10 Aug 2020 (actual)
Results: Posted 30 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Family-based mental health navigation	Experimental	Behavioral: Family-based mental health navigationFamily-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
Standard of Care (Clinic Case Management)	Active comparator	Behavioral: Standard of Care (Clinic Case Management)Standard of care case management practices and services-as-usual

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

Youth is not English-speaking
Caregiver has impairment that would preclude providing informed consent
Unavailable guardian for consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Family-based mental health navigationFamily-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement	Behavioural	Family-based mental health navigation
Standard of Care (Clinic Case Management)Standard of care case management practices and services-as-usual	Behavioural	Standard of Care (Clinic Case Management)

Primary outcome

Time to Treatment Referral
Time frame: 12 months post enrollment
Number of days until treatment referral is made
Time to Treatment Initiation
Time frame: 12 months post enrollment
Number of days until attendance at first treatment session
Treatment Engagement: Number of Participants in Treatment for 6 or More Weeks
Time frame: 12 months post enrollment
Engagement as measured by attendance in treatment for 6 or more weeks

Results and safety

Results posted to the registry on 30 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Family-based Mental Health Navigation	38	38
Standard of Care (Clinic Case Management)	38	38

Primary outcome: Time to Treatment Referral

Time frame: 12 months post enrollment. Mean (Full Range). Unit: days

Measure	Family-based Mental Health Navigation n = 13	Standard of Care (Clinic Case Management) n = 13
Value	56 (12 to 169)	13 (0 to 71)

Population analysed: Time to treatment referral data were available for only 26 youth participants (13 in the family-based mental health navigation intervention and 13 in the standard of care condition) due to changes in the electronic medical record system.

Primary outcome: Time to Treatment Initiation

Time frame: 12 months post enrollment. Mean (Full Range). Unit: days

Measure	Family-based Mental Health Navigation n = 4	Standard of Care (Clinic Case Management) n = 1
Value	3 (3 to 19)	2 (2 to 2)

Population analysed: Time to treatment initiation data were only available for 4 youth participants in the family-based mental health navigation intervention and 1 youth participant in the standard of care condition.

Primary outcome: Treatment Engagement: Number of Participants in Treatment for 6 or More Weeks

Time frame: 12 months post enrollment. Count of participants. Unit: Participants

Measure	Family-based Mental Health Navigation n = 10	Standard of Care (Clinic Case Management) n = 3
Value	5	1

Population analysed: Treatment engagement data were only available for 10 youth participants in the family-based mental health navigation intervention and 3 youth participants in the standard of care condition.

Adverse events

Time frame: Adverse event data were collected throughout the randomized controlled trial period (e.g., ~3 years).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Family-based Mental Health Navigation	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Standard of Care (Clinic Case Management)	0 of 38 (0%)	0 of 38 (0%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37698896Tolou-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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marina Tolou-Shams, Ph.D principal investigator

UC San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Treatment Referral (time frame: 12 months post enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04506437, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.