Foster Care Mental Health Family Navigator

Mental Health Clinical Trial

— FCFN  

Official title:

Foster Care Mental Health Family Navigator

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506437
• Other study ID #: 1R34MH119433-01A1
• Secondary ID: 1R34MH119433-01A
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2023
• Source: University of California, San Francisco
• Contact: Marina Tolou-Shams, Ph.D
• Phone: 628-206-2212
• Email: marina.tolou-shams[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health

Intervention

Behavioral:
• Family-based mental health navigation
Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
• Standard of care engagement practices
Standard of care engagement practices and services-as-usual

Locations

Country	Name	City	State
United States	UCSF Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to treatment referral	Number of days until treatment referral is made	12 months post enrollment
Primary	Time to treatment initiation	Number of days until attendance at first treatment session	12 months post enrollment
Primary	Treatment engagement	Engagement as measured by attendance in treatment for 6 or more weeks	12 months post enrollment