Foster Care Mental Health Family Navigator (FCFN)

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: Family-based mental health navigation; Behavioral: Standard of care engagement practices

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.

• Study Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marina Tolou-Shams, Ph.D; Phone Number: 628-206-2212; Email: marina.tolou-shams@ucsf.edu
• Study Contact Backup: Name: Lakshmi Gopalakrishnan, MSc; Phone Number: 415-509-5999; Email: lakshmi.gopalakrishnan@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94131
      • Recruiting
      • UCSF Zuckerberg San Francisco General Hospital
      • Contact: Marina Tolou-Shams, PhD; Phone Number: 628-206-2212; Email: marina.tolou-shams@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family-based mental health navigation; Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement	Behavioral: Family-based mental health navigation; Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
Active Comparator: Standard of care, then family-based mental health navigation; During wait-list period receive standard of care engagement practices and services-as-usual, and after the wait-list period the participants receive the family-based navigator intervention combined with mHealth practices	Behavioral: Family-based mental health navigation; Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement; Behavioral: Standard of care engagement practices; Standard of care engagement practices and services-as-usual

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Marina Tolou-Shams, Ph.D, UC San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Adolescent; Mental Health; Navigator; Foster Care; Service Access
• Other Study ID Numbers: 1R34MH119433-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No