NCT04822636

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 6, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 7, 2025

Status Verified

April 1, 2025

Enrollment Period

3.8 years

First QC Date

March 25, 2021

Last Update Submit

April 4, 2025

Conditions

Mental Health

Keywords

AdolescentPublicly-insured YouthMental HealthNavigator ServiceAccessChildren

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

Family-based mental health navigation

EXPERIMENTAL

Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement

Behavioral: Family-based mental health navigation

Interventions

Family-based mental health navigationBEHAVIORAL

Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement

Family-based mental health navigation

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Youth is not English-speaking nor Spanish-speaking
  • Caregiver has impairment that would preclude providing informed consent
  • Unavailable guardian for consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Zuckerberg San Francisco General Hospital

San Francisco, California, 94131, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Marina Tolou-Shams, Ph.D

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Tolou-Shams, Ph.D

CONTACT

628-206-2212marina.tolou-shams@ucsf.edu

Juliet Yonek, Ph.D.

CONTACT

628-206-2452juliet.yonek@ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a within-person, pre-post 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

March 30, 2021

Study Start

June 6, 2022

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

April 7, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)