The SolanoConnex Trial: Evaluation of a Mental Health Access Project

NCT07306013 | Recruiting

• 1 other identifier: MHAS2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the effectiveness of the SolanoConnex.org program on help-seeking attitudes and help-seeking behaviors among users compared to a control group. This study will employ a randomized controlled trial design with two parallel arms. Participants in the intervention group will receive full access and orientation to SolanoConnex.org, including multiple features designed to enhance engagement with local mental health resources. Participants in the control group will receive publicly available mental health resources. The primary outcome is any use of mental health services including conversations and communication, digital engagement and media consumption, direct service use or self-help and alternative support all of which will be self-reported through digital diaries prompted every two weeks. Secondary outcomes are endorsed and anticipated Stigma related to mental health, help-seeking attitudes, self-efficacy in seeking mental health care. Potential covariates include demographics, past mental health service use and satisfaction, readiness to change, and discrimination experiences during past healthcare use.

Conditions

Mental Health

Keywords

mental health; web application; community-based

Outcome Measures

Primary Outcomes (1)

• Use of any mental health services

  Mental health service utilization (i.e. appointment with therapist, attendance at grief group, commencement of PTSD treatment)

  From enrollment to the end of the 4 month study period

Secondary Outcomes (3)

• Stigma Related to Mental Health

  From enrollment to the end of the 4 month period

• Mental Health Help Seeking Attitudes

  From enrollment to the end of the 4 month period

• Self-efficacy in seeking Mental Health Care

  From enrollment to the end of the 4 month period

Study Arms (2)

Mental Health Navigator and App Intervention Group

EXPERIMENTAL

Participants in the intervention group will be blinded to their study arm status. They will receive full access and orientation to SolanoConnex.org, including multiple features designed to enhance engagement with local mental health resources. First, they will be granted access to the SolanoConnex.org website and mobile application, educational materials, social media and resource navigation. To facilitate ease of use, participants will receive a step-by-step guide and a tutorial video demonstrating how to navigate the platform's features. Additionally, they will gain access to SolanoConnex-produced videos and podcasts which profiles mental health providers and covers various mental health topics.

Behavioral: Access to the SolanoConnex.org

Standard County Mental Health Information Control

NO INTERVENTION

Participants in the control group will also be blinded to their study arm status. They will receive generic materials consisting of access to publicly available mental health resources without exposure to SolanoConnex.org or its patient navigator services. They will be provided with general information on national mental health hotlines, local mental health services, and online directories of available resources but will not receive specific training or guidance in using these resources.

Interventions

Access to the SolanoConnex.org BEHAVIORAL

Participants in the intervention group will be blinded to their study arm status. They will receive full access and orientation to SolanoConnex.org, including multiple features designed to enhance engagement with local mental health resources. First, they will be granted access to the SolanoConnex.org website and mobile application, educational materials, social media and resource navigation. To facilitate ease of use, participants will receive a step-by-step guide and a tutorial video demonstrating how to navigate the platform's features. Additionally, they will gain access to SolanoConnex-produced videos and podcasts which profiles mental health providers and covers various mental health topics. To further support participants, patient navigators will be available to provide personalized assistance, helping individuals connect with relevant services. At the outset of the study, participants will receive detailed instructions on how to access and utilize patient navigator support.

Mental Health Navigator and App Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Resident of Solano County, CA.
• Mild to moderate mental health symptoms as reported on the DSM-5 Level 1 Measure for Adult Mental Health screening form.
• Own a personal smartphone with internet access or a data plan to facilitate engagement with the digital platform.
• Be fluent in English, as all study components will be conducted in English.
• Have not previously used SolanoConnex.org.

You may not qualify if:

• Are currently engaged in or have had comprehensive case management or counseling services within the past 6 months.
• Do not reside in Solano County.
• Lack fluency in English, as study materials and communications will be conducted in English.
• Have previously accessed SolanoConnex.org, as prior exposure may influence study outcomes.

Sponsors & Collaborators

• Touro University, California: lead
• Solano County Board of Supervisors: collaborator

Study Sites (1)

Touro University, California

Vallejo, California, 94592, United States

RECRUITING

Related Links

• Recruitment site

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Central Study Contacts

Carinne Brody, DrPH, MPH, MA

CONTACT

707-902-3043; cbrody@touro.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: December 26, 2025
• Study Start: July 13, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: July 1 2026 - June 31, 2027
• Access Criteria: De-identified IPD will be made available upon reasonable request to qualified researchers, subject to approval by the study investigators and completion of a data use agreement. Requests should specify the research question, analysis plan, and intended use of the data.

Locations

US (1)