Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04822636
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Collaborator:
San Francisco General Hospital Foundation
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Mental Health Behavioral: Family-based mental health navigation Behavioral: Standard of care engagement practices Not Applicable

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, relative to standard of care (not participating in FMHN 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 FMHN model.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a dynamic wait-listed 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Family Mental Health Family Navigator
Estimated Study Start Date : April 15, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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




Primary Outcome Measures :
  1. Time to treatment referral [ Time Frame: 12 months post enrollment ]
    Number of days until treatment referral is made

  2. Time to treatment initiation [ Time Frame: 12 months post enrollment ]
    Number of days until attendance at first treatment session

  3. Treatment engagement [ Time Frame: 12 months post enrollment ]
    Engagement as measured by attendance in treatment for 6 or more weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English-speaking and/or Spanish-speaking youth
  • Ages 12-17
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04822636


Contacts
Layout table for location contacts
Contact: Marina Tolou-Shams, Ph.D 628-206-2212 marina.tolou-shams@ucsf.edu
Contact: Catalina Ordorica, M.Ed 628-206-2822 catalina.ordorica@ucsf.edu

Locations
Layout table for location information
United States, California
UCSF Zuckerberg San Francisco General Hospital Recruiting
San Francisco, California, United States, 94131
Contact: Marina Tolou-Shams, PhD    628-206-2212    marina.tolou-shams@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
San Francisco General Hospital Foundation
Investigators
Layout table for investigator information
Principal Investigator: Marina Tolou-Shams, Ph.D University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04822636    
Other Study ID Numbers: 1929675
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Adolescent
Publicly-insured Youth
Mental Health
Navigator Service
Access