By Youth, For Youth: Digital Supported Peer Navigation for Addressing Child Mental Health Inequities

Sponsor

University of California, Riverside (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06122688

Collaborator

University of California, San Francisco (Other), University of California, Los Angeles (Other), National Institute of Mental Health (NIMH) (NIH)

8,360

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated 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.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

Anticipated Study Start Date :

Mar 31, 2024

Anticipated Primary Completion Date :

Apr 1, 2027

Anticipated Study Completion Date :

Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.
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.	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.

Arm

Intervention/Treatment

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.

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.

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.

Outcome Measures

Primary Outcome Measures

Proportion of youth referred to mental health services who initiate care. [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. [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. [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. [1 year]
Mental health initiation and visit data will be obtained from electronic medical records.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Youth 13-22 enrolled in high school or participating primary care clinics, and their caregivers.

Exclusion Criteria:

Those not meeting inclusion criteria

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of California, Riverside

ClinicalTrials.gov Identifier:

NCT06122688

Other Study ID Numbers:

U01MH131827

First Posted:

Nov 8, 2023

Last Update Posted:

Nov 8, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Nov 8, 2023