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Foster Care Mental Health Family Navigator

Foster Care Mental Health Family Navigator

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04506437
Acronym
FCFN
Enrollment
76
Registered
2020-08-10
Start date
2020-08-20
Completion date
2025-04-01
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health

Keywords

Adolescent, Foster Care, Mental Health, Navigator, Service Access

Brief 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.

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.

Interventions

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

BEHAVIORALStandard of Care (Clinic Case Management)

Standard of care case management practices and services-as-usual

Sponsors

University of California, San Francisco
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Time to Treatment Referral12 months post enrollmentNumber of days until treatment referral is made
Time to Treatment Initiation12 months post enrollmentNumber of days until attendance at first treatment session
Treatment Engagement: Number of Participants in Treatment for 6 or More Weeks12 months post enrollmentEngagement as measured by attendance in treatment for 6 or more weeks

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMarina Tolou-Shams, Ph.D

UC San Francisco

Participant flow

Recruitment details

A total of 76 participants were recruited as youth-caregiver dyads. There were a total of 38 participants (or 19 youth-caregiver dyads) in each condition.

Baseline characteristics

Characteristic
Age, Continuous
Caregiver Age Demographics
44.53 years
Age, Continuous
Youth Age Demographics
14.22 years
Race (NIH/OMB)
Caregiver Race Demographics
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Caregiver Race Demographics
Asian
1 Participants
Race (NIH/OMB)
Caregiver Race Demographics
Black or African American
7 Participants
Race (NIH/OMB)
Caregiver Race Demographics
More than one race
0 Participants
Race (NIH/OMB)
Caregiver Race Demographics
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Caregiver Race Demographics
Unknown or Not Reported
23 Participants
Race (NIH/OMB)
Caregiver Race Demographics
White
1 Participants
Race (NIH/OMB)
Youth Race Demographics
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Youth Race Demographics
Asian
2 Participants
Race (NIH/OMB)
Youth Race Demographics
Black or African American
9 Participants
Race (NIH/OMB)
Youth Race Demographics
More than one race
1 Participants
Race (NIH/OMB)
Youth Race Demographics
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Youth Race Demographics
Unknown or Not Reported
26 Participants
Race (NIH/OMB)
Youth Race Demographics
White
0 Participants
Sex: Female, Male
Caregiver Sex Demographics
Female
16 Participants
Sex: Female, Male
Caregiver Sex Demographics
Male
2 Participants
Sex: Female, Male
Youth Sex Demographics
Female
20 Participants
Sex: Female, Male
Youth Sex Demographics
Male
8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 380 / 38
other
Total, other adverse events
0 / 380 / 38
serious
Total, serious adverse events
0 / 380 / 38

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026