Family Mental Health Family Navigator Project (FMHN) (FMHN)

Family Mental Health Family Navigator

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: Family-based mental health navigation

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• 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: Juliet Yonek, Ph.D.; Phone Number: 628-206-2452; Email: juliet.yonek@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: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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

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: San Francisco General Hospital Foundation
• Investigators: Principal Investigator: Marina Tolou-Shams, Ph.D, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 7, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Adolescent; Mental Health; Children; Access; Publicly-insured Youth; Navigator Service
• Other Study ID Numbers: 1929675

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