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Foster Care Mental Health Family Navigator (FCFN)

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ClinicalTrials.gov Identifier: NCT04506437
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : September 24, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
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 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.

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 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 (FCFN) while also collecting data on the FCFN model's potential implementation and adoption within child welfare and behavioral health settings.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Foster Care Mental Health Family Navigator
Actual Study Start Date : August 20, 2020
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 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

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04506437


Contacts
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Contact: Marina Tolou-Shams, Ph.D 628-206-2212 marina.tolou-shams@ucsf.edu
Contact: Juliet Yonek, Ph.D 628-206-2452 juliet.yonek@ucsf.edu

Locations
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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
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Marina Tolou-Shams, Ph.D UC San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04506437    
Other Study ID Numbers: 1R34MH119433-01A1 ( U.S. NIH Grant/Contract )
1R34MH119433-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Foster Care
Mental Health
Navigator
Service Access