The SolanoConnex Trial: Evaluation of a Mental Health Access Project

December 18, 2025 updated by: Touro University, California

The SolanoConnex Trial: A Single-blind Randomized Controlled Trial of a Digital and Community-based Mental Health Access Project

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Carinne Brody, DrPH, MPH, MA
  • Phone Number: 707-902-3043
  • Email: cbrody@touro.edu

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mental Health Navigator and App Intervention Group
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

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.
No Intervention: Standard County Mental Health Information Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of any mental health services
Time Frame: From enrollment to the end of the 4 month study period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stigma Related to Mental Health
Time Frame: From enrollment to the end of the 4 month period
Endorsed and Anticipated Stigma Inventory (EASI): The EASI is a 40-item self-report inventory that consists of 5 scales assessing mental health beliefs that may be particularly salient for military and Veteran populations, particularly with regard to their willingness to seek mental health treatment. Respondents are asked to rate 8 items in each of 5 scales, 3 that address key aspects of endorsed stigma and 2 that assess key aspects of anticipated stigma. Each scale uses a 5-point Likert-type response format: 1 (strongly disagree), 2 (somewhat disagree), 3 (neither agree nor disagree), 4 (somewhat agree), 5 (strongly agree). Items within each of the 5 scales can be summed to create individual 5 scale scores. The higher the score, the higher the stigma.
From enrollment to the end of the 4 month period
Mental Health Help Seeking Attitudes
Time Frame: From enrollment to the end of the 4 month period
Mental Help Seeking Attitudes Scale (MHSAS): The MHSAS contains nine items which produce a single mean score. The MHSAS uses a seven-point semantic differential scale. In order to properly calculate the MHSAS mean score, where a higher mean score indicates more favorable attitudes, it is necessary to reverse-code items 2, 5, 6, 8, and 9.
From enrollment to the end of the 4 month period
Self-efficacy in seeking Mental Health Care
Time Frame: From enrollment to the end of the 4 month period
Self-efficacy in Seeking Mental Health Care Scale: Sum all 9 items. Higher scores indicate greater self-efficacy for seeking mental health care.
From enrollment to the end of the 4 month period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Touro University, California

Collaborators

Solano County Board of Supervisors

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

July 14, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHAS2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD), including the analyzable dataset underlying published results, may be shared.

IPD Sharing Time Frame

July 1 2026 - June 31, 2027

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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