Mental HealthNCT07306013
The SolanoConnex Trial: Evaluation of a Mental Health Access Project
A study testing Access to the SolanoConnex.org in people with Mental Health, run by Touro University, California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Access to the SolanoConnex.org
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Touro University, California
Vallejo, California, 94592
Taylor Moss, MPH, 707-902-3043, solanomentalhealthstudy@gmail.com
About this study
Official title: 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.
- Conditions
- Mental Health
- Being tested
- Access to the SolanoConnex.org
- Keywords
- mental health, web application, community-based
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to the SolanoConnex.orgBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of any mental health services
Mental health service utilization (i.e. appointment with therapist, attendance at grief group, commencement of PTSD treatment)
Measured: From enrollment to the end of the 4 month study period
Secondary outcomes (3)
Stigma Related to Mental Health
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.
Measured: From enrollment to the end of the 4 month period
Mental Health Help Seeking Attitudes
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.
Measured: From enrollment to the end of the 4 month period
Self-efficacy in seeking Mental Health Care
Self-efficacy in Seeking Mental Health Care Scale: Sum all 9 items. Higher scores indicate greater self-efficacy for seeking mental health care.
Measured: From enrollment to the end of the 4 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start13 Jul 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Touro University, California
- Sponsor type
- University, hospital or other
- Collaborators
- Solano County Board of Supervisors
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306013
- Sponsor's protocol ID
- MHAS2025
- Status last verified
- Dec 2025
- First submitted
- 14 Jul 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including the analyzable dataset underlying published results, may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SolanoConnex Trial: A Single-blind Randomized Controlled Trial of a Digital and Community-based Mental Health Access Project
- ClinicalTrials.gov ID
- NCT07306013
- Acronym / sponsor ID
- MHAS2025
- Conditions
- Mental Health
- Keywords
- mental health, web application, community-based
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Touro University, CaliforniaUniversity, hospital or other
- Collaborators
- Solano County Board of Supervisors
- Study start
- 13 Jul 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental Health Navigator and App Intervention Group | Experimental | Behavioral: Access to the SolanoConnex.orgParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to the SolanoConnex.orgParticipants 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. | Behavioural | Mental Health Navigator and App Intervention Group |
Primary outcome
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)
3 secondary outcomes
Stigma Related to Mental Health
Time frame: 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
Self-efficacy in seeking Mental Health Care
Time frame: From enrollment to the end of the 4 month period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Recruitment siteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including the analyzable dataset underlying published results, may be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to the SolanoConnex.org in people with Mental Health, run by Touro University, California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carinne Brody, DrPH, MPH, MA (707-902-3043, cbrody@touro.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of any mental health services (time frame: From enrollment to the end of the 4 month study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.