By Youth, For Youth: Digital Supported Peer Navigation for Addressing Child Mental Health Inequities
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| ClinicalTrials.gov Identifier: NCT06122688 |
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Recruitment Status :
Not yet recruiting
First Posted : November 8, 2023
Last Update Posted : November 8, 2023
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Sponsor:
University of California, Riverside
Collaborators:
University of California, San Francisco
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Riverside
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Brief Summary:
Black and Latino youth are more likely to experience an unmet mental health or psychosocial need than do their white counterparts. Schools and primary care clinics are ideal hubs to provide mental health, healthcare, social services, and prevention to students and families who otherwise face barriers to care. Using Participatory Design and Community Partnered Participatory Research (CPPR) for app development, mobile technology is designed to optimize access to wellness resources. The proposed intervention is a model of care using technology and navigators for connecting youth ages 13-22 to mental health care and supports. The app is co-created with the community and supported by culturally responsive individuals called family and youth navigators, in schools and primary care clinics. Outcomes are measured using the cascade of care model.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anxiety Depression Mental Health Issue | Behavioral: Navigator Plus App Intervention | Not Applicable |
Using Participatory Design and Community Partnered Participatory Research (CPPR), UCLA and UCR psychiatry research centers with Los Angeles Trust for Children's Health aim to: (1) Fully co-design (with youth, caregivers, clinicians and other stakeholders) an innovative mental health digital tool, called Connected for Wellness, to implement algorithmically supported mental health + social determinants, resiliency app based tools and navigation activities AND help support the clinical workforce within schools and primary care clinics (PCCs); (2) Study the implementation of mental health navigation models (family and youth navigation) plus the Connected for Wellness app, and their effectiveness for improving connecting and matching youth to the right level of care and supports. We will accomplish these aims through three strategies: (1) Use community participatory informatics to co-design a mental health digital tool called Connected for Wellness, to support mental health navigation, linking youth to a range of mental health services, evidence-based prevention resources referred via the app, and other school, clinic, community, and social supports; (2) Integrate mental health self-assessments and artificial intelligence (AI) in Connected for Wellness to individualize app resources, optimize engagement and recommendations for addressing mental health and social needs; (3) Using a stepped wedge design, test the implementation of the app supported by mental health navigation models (peer navigators, family navigators) for improving connections and access to prevention resources, mental health services and social supports, for youth and families. This project will be initiated with youth 13-22 years old and their family and community members across 10 Los Angeles County Schools and 10 Riverside County/University of California Riverside primary care clinics, which serve mostly Black, Latino, and Asian youth. A successful outcome of the project is a CPPR developed app-based intervention implementable in school-based and primary care services for access to wellness resources and improving mental health services access along the cascade of care. Outcomes are measured using the cascade of care model with the following key stages: (1) need identification, (2) referral to care/ linkage to resources, and (3) care initiation.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 8360 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model Description: | In each county, 10 sites will participate (10 high schools in Los Angeles and 10 Primary Care Clinics in Riverside), with sites randomized to cross over from control to intervention status in a step wedged design each Fall following the beginning of the school year. Three months is allowed for training and setup at each site prior to intervention delivery. |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | By Youth, For Youth: Digital Supported Peer Navigation for Addressing Child Mental Health Inequities |
| Estimated Study Start Date : | March 31, 2024 |
| Estimated Primary Completion Date : | April 1, 2027 |
| Estimated Study Completion Date : | April 1, 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Care as usual
All individuals within each site regardless of type of site or step period will begin with a control period of care as usual Youth and parents within each site will have access to navigators who will share information about mental health and social services supports as well as referrals. The duration of the control period (1, 2, or 3 years; collected via medical and/or other administrative records) will depend on the step period of the individual's site. |
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Experimental: Implementation
In this stepped wedge design, following a period of care as usual as a control, sites will then cross over to the experimental arm, during which, all youth and their caregivers at the enrolled site are encouraged to download and use the wellness app for the duration of the implementation period. Navigators promote and support use of the app.
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Behavioral: Navigator Plus App Intervention
Navigators will provide their usual care services and also be encouraged to use the Connected for Wellness (CFW) app during their usual activities with youth and caregivers at their site. The duration of this period (2, 3, or 4 years) will depend on the step period of the individual's site. All youth at the school or clinic site can use the CFW app on their own and through the app receive prevention strategies, psycho-education that destigmatizes mental health, encourages referrals to local resources as needed, and increases motivation to access care if needed. |
Primary Outcome Measures :
- Proportion of youth referred to mental health services who initiate care. [ Time Frame: 1 year ]Referral to and initiation of mental health services data will be obtained from electronic medical records.
Secondary Outcome Measures :
- Proportion of youth completing a mental health screening who are referred to care. [ Time Frame: 1 year ]Mental health screening and referral to mental health services data will be obtained from electronic medical records.
Other Outcome Measures:
- Proportion of youth in school/clinic completing a mental health screening. [ Time Frame: 1 year ]Mental health screening data will be obtained from electronic medical records.
- Proportion of youth initiating mental health services who have 3 or more visits. [ Time Frame: 1 year ]Mental health initiation and visit data will be obtained from electronic medical records.
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| Ages Eligible for Study: | 13 Years to 99 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Youth 13-22 enrolled in high school or participating primary care clinics, and their caregivers.
Exclusion Criteria:
- Those not meeting inclusion criteria
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): NCT06122688
Contacts
| Contact: Lisa Fortuna, MD, MPH | (951) 827-0742 | lisa.fortuna@medsch.ucr.edu | |
| Contact: Sheryl Kataoka, MD, MSHS | skataoka@mednet.ucla.edu |
Sponsors and Collaborators
University of California, Riverside
University of California, San Francisco
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Publications:
| Responsible Party: | University of California, Riverside |
| ClinicalTrials.gov Identifier: | NCT06122688 |
| Other Study ID Numbers: |
U01MH131827 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 8, 2023 Key Record Dates |
| Last Update Posted: | November 8, 2023 |
| Last Verified: | November 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Depression Behavioral Symptoms |