Clinical trial NCT04822636: Family Mental Health Family Navigator Project (FMHN)
Official title: Family Mental Health Family Navigator
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Keywords: Adolescent
Publicly-insured Youth
Mental Health
Navigator Service
Access
Children
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco General Hospital Foundation
First posted: 2021-03-30
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a within-person, pre-post design in which the investigators will test a theory-driven, family-based navigator treatment engagement intervention (FMHN) while also collecting data on the FMHN model's potential implementation and adoption within a public hospital 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 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.

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.

Eligibility criteria: 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

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: University of California, San Francisco
name: Marina Tolou-Shams, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: