Clinical trial NCT04506437: Foster Care Mental Health Family Navigator
Official title: Foster Care Mental Health Family Navigator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Keywords: Adolescent
Foster Care
Mental Health
Navigator
Service Access
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-08-10
Enrollment: 124
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a dynamic wait-listed 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.
Primary purpose: TREATMENT

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 (not participating in FCFN intervention). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to treatment referral
timeFrame: 12 months post enrollment
measure: Time to treatment initiation
timeFrame: 12 months post enrollment
measure: Treatment engagement
timeFrame: 12 months post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Zuckerberg San Francisco General Hospital
state: California
Study officials:
affiliation: UC San Francisco
name: Marina Tolou-Shams, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: