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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06122688
Other study ID # U01MH131827
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 31, 2024
Est. completion date April 1, 2027

Study information

Verified date November 2023
Source University of California, Riverside
Contact Lisa Fortuna, MD, MPH
Phone (951) 827-0742
Email lisa.fortuna@medsch.ucr.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 8360
Est. completion date April 1, 2027
Est. primary completion date April 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 99 Years
Eligibility Inclusion Criteria: - Youth 13-22 enrolled in high school or participating primary care clinics, and their caregivers. Exclusion Criteria: - Those not meeting inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
University of California, Riverside National Institute of Mental Health (NIMH), University of California, Los Angeles, University of California, San Francisco

References & Publications (10)

Arevian AC, Jones F, Moore EM, Goodsmith N, Aguilar-Gaxiola S, Ewing T, Siddiq H, Lester P, Cheung E, Ijadi-Maghsoodi R, Gabrielian S, Sugarman OK, Bonds C, Benitez C, Innes-Gomberg D, Springgate B, Haywood C, Meyers D, Sherin JE, Wells K. Mental Health Community and Health System Issues in COVID-19: Lessons from Academic, Community, Provider and Policy Stakeholders. Ethn Dis. 2020 Sep 24;30(4):695-700. doi: 10.18865/ed.30.4.695. eCollection 2020 Fall. — View Citation

Balcombe L, De Leo D. Digital Mental Health Challenges and the Horizon Ahead for Solutions. JMIR Ment Health. 2021 Mar 29;8(3):e26811. doi: 10.2196/26811. — View Citation

Cook BL, Trinh NH, Li Z, Hou SS, Progovac AM. Trends in Racial-Ethnic Disparities in Access to Mental Health Care, 2004-2012. Psychiatr Serv. 2017 Jan 1;68(1):9-16. doi: 10.1176/appi.ps.201500453. Epub 2016 Aug 1. — View Citation

Ellis DM, Draheim AA, Anderson PL. Culturally adapted digital mental health interventions for ethnic/racial minorities: A systematic review and meta-analysis. J Consult Clin Psychol. 2022 Oct;90(10):717-733. doi: 10.1037/ccp0000759. Epub 2022 Oct 13. — View Citation

Fortuna LR, Tolou-Shams M, Robles-Ramamurthy B, Porche MV. Inequity and the disproportionate impact of COVID-19 on communities of color in the United States: The need for a trauma-informed social justice response. Psychol Trauma. 2020 Jul;12(5):443-445. doi: 10.1037/tra0000889. Epub 2020 Jun 1. — View Citation

Kataoka SH, Vona P, Acuna A, Jaycox L, Escudero P, Rojas C, Ramirez E, Langley A, Stein BD. Applying a Trauma Informed School Systems Approach: Examples from School Community-Academic Partnerships. Ethn Dis. 2018 Sep 6;28(Suppl 2):417-426. doi: 10.18865/ed.28.S2.417. eCollection 2018. — View Citation

Lyon AR, Koerner K. User-Centered Design for Psychosocial Intervention Development and Implementation. Clin Psychol (New York). 2016 Jun;23(2):180-200. doi: 10.1111/cpsp.12154. Epub 2016 Jun 17. — View Citation

Marrast L, Himmelstein DU, Woolhandler S. Racial and Ethnic Disparities in Mental Health Care for Children and Young Adults: A National Study. Int J Health Serv. 2016 Oct;46(4):810-24. doi: 10.1177/0020731416662736. Epub 2016 Aug 12. — View Citation

Park SY, Nicksic Sigmon C, Boeldt D. A Framework for the Implementation of Digital Mental Health Interventions: The Importance of Feasibility and Acceptability Research. Cureus. 2022 Sep 19;14(9):e29329. doi: 10.7759/cureus.29329. eCollection 2022 Sep. — View Citation

Porche MV, Folk JB, Tolou-Shams M, Fortuna LR. Researchers' Perspectives on Digital Mental Health Intervention Co-Design With Marginalized Community Stakeholder Youth and Families. Front Psychiatry. 2022 Apr 22;13:867460. doi: 10.3389/fpsyt.2022.867460. eCollection 2022. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Proportion of youth in school/clinic completing a mental health screening. Mental health screening data will be obtained from electronic medical records. 1 year
Other Proportion of youth initiating mental health services who have 3 or more visits. Mental health initiation and visit data will be obtained from electronic medical records. 1 year
Primary Proportion of youth referred to mental health services who initiate care. Referral to and initiation of mental health services data will be obtained from electronic medical records. 1 year
Secondary Proportion of youth completing a mental health screening who are referred to care. Mental health screening and referral to mental health services data will be obtained from electronic medical records. 1 year
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