Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH119433-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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 (case management). 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family-based mental health navigation | Experimental | Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement |
|
| Standard of Care (Clinic Case Management) | Active Comparator | Standard of care case management practices and services-as-usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-based mental health navigation | Behavioral | Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement |
| 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: Number of Participants in Treatment for 6 or More Weeks | Engagement as measured by attendance in treatment for 6 or more weeks | 12 months post enrollment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marina Tolou-Shams, Ph.D | UC San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Zuckerberg San Francisco General Hospital | San Francisco | California | 94131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37698896 | Derived | Tolou-Shams M, Ramaiya M, Lara Salas J, Ezimora I, Shumway M, Duerr Berrick J, Aguilera A, Borsari B, Dauria E, Friedling N, Holmes C, Grandi A. A Family-Based Mental Health Navigator Intervention for Youth in the Child Welfare System: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 12;12:e49999. doi: 10.2196/49999. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 76 participants were recruited as youth-caregiver dyads. There were a total of 38 participants (or 19 youth-caregiver dyads) in each condition.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Family-based Mental Health Navigation | Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement Family-based mental health navigation: Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement |
| FG001 | Standard of Care (Clinic Case Management) | Standard of care engagement practices: Standard of care engagement practices and services-as-usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Family-based Mental Health Navigation | Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement Family-based mental health navigation: Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Treatment Referral | Number of days until treatment referral is made | Time to treatment referral data were available for only 26 youth participants (13 in the family-based mental health navigation intervention and 13 in the standard of care condition) due to changes in the electronic medical record system. | Posted | Mean | Full Range | days | 12 months post enrollment |
|
Adverse event data were collected throughout the randomized controlled trial period (e.g., ~3 years).
The adverse event and/or serious adverse event used to collect adverse event information does not differ from clinicaltrials.gov definitions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Family-based Mental Health Navigation | Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement Family-based mental health navigation: Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jannet Lara Salas | University of San Francisco, California | 415-962-6972 | jannet.larasalas@ucsf.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 1, 2023 | Mar 31, 2026 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
This is a randomized controlled trial 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.
Not provided
Not provided
Not provided
Not provided
| Standard of Care (Clinic Case Management) | Behavioral | Standard of care case management practices and services-as-usual |
|
| BG001 |
| Standard of Care (Clinic Case Management) |
Standard of care case management practices and services-as-usual |
| BG002 | Total | Total of all reporting groups |
| Median |
| Full Range |
| years |
|
| Sex: Female, Male | Sex demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. Note: Sex demographic data were missing for 1 youth in the intervention condition (did not complete baseline), 3 caregivers in the intervention condition (did not complete baseline), and 1 caregiver in the control condition (did not complete baseline). Note that this was an intent to treat trial design. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. | Count of Participants | Participants |
|
Standard of care case management practices and services-as-usual |
|
|
| Primary | Time to Treatment Initiation | Number of days until attendance at first treatment session | Time to treatment initiation data were only available for 4 youth participants in the family-based mental health navigation intervention and 1 youth participant in the standard of care condition. | Posted | Mean | Full Range | days | 12 months post enrollment |
|
|
|
| Primary | Treatment Engagement: Number of Participants in Treatment for 6 or More Weeks | Engagement as measured by attendance in treatment for 6 or more weeks | Treatment engagement data were only available for 10 youth participants in the family-based mental health navigation intervention and 3 youth participants in the standard of care condition. | Posted | Count of Participants | Participants | 12 months post enrollment |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Standard of Care (Clinic Case Management) | standard of care case management practices and services-as-usual | 0 | 38 | 0 | 38 | 0 | 38 |
Not provided
Not provided
| Male |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|