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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Touro University, California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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