Family Mental Health Family Navigator Project (FMHN)

Mental Health Clinical Trial

— FMHN  

Official title:

Family Mental Health Family Navigator

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04822636
• Other study ID #: 1929675
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: December 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

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

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	San Francisco General Hospital Foundation

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