Mental Health StrategiesASSIST-MHNCT06728683
Assist MH Digital Technologies to Support School Mental Health Care
A study testing ASSIST-MH in people with Mental Health Strategies and School Mental Health Services, run by 3-C Institute for Social Development at 1 site in United States.
Trial summary
The goal of this SBIR is to develop and test Assist-MH, a new interactive digital support system for SMH providers. Assist-MH will offer SMH treatment resources to help providers implement a more customized treatment plan specific to the student's needs. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Strategies, School Mental Health Services, Digital Technologies
- What is being tested?
- ASSIST-MH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 18 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- must be a SMH provider (providing services to 12- to 17-year-old students) or a student (12 to 17 years old)
- must have access to internet
- must be English language proficient.
- No one will be excluded based on gender, race, or ethnic background.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
3-C Institute for Social Development, Inc
Durham, North Carolina, 27713
About this study
The goal of this SBIR is to develop and test Assist-MH, a new interactive digital support system for SMH providers. Assist-MH will offer SMH treatment resources to help providers implement a more customized treatment plan specific to the student's needs. Based on student areas of need, the system will deliver both provider-led MH strategies to optimize time spent with the student and self-paced digital strategies (video, game-based, interactive) for students to augment in-person treatment and provide unique between-session learning and practice.
Read the detailed description
This 12-month Phase I project will accomplish three specific objectives: (1) conduct iterative testing with SMH providers, (2) create the fully functioning Assist-MH software prototype, and (3) pilot test the prototype with SMH providers (and their students). The first aim is to gather input from key stakeholders. From those who volunteer, investigators will randomly select 36 participants: 12 providers, 12 supervisors, and 12 administrators. To support diversity and generalizability of initial stakeholder feedback, investigators will stratify random selection to obtain equal participation by gender and 50% non-White participation which is expected to approximate 26% Black, 13% Asian American, and 11% multi-racial or other minority subgroup, with 12% of reporting Latinx/Hispanic ethnicity. Following random selection and consenting, stakeholders will participate in a 60-minute virtual focus group (separately by stakeholder type, 6-8 per group). In a semi-structured fashion, the PI will present initial design concepts and examples for each product component. Focus group discussions will be designed to identify pain points and barriers faced by SMH staff and opportunities to lower barriers to SMH service delivery as well as to gather specific recommendations. Following group participation, stakeholders will rate the value (innovation, usefulness, need), feasibility (time efficient, cost efficient, doable), and acceptability (quality of content, accessibility, scope) of the proposed Assist-MH product components. Ratings will be made on a 5-point scale from 1 (Strongly Disagree) to 5 (Strongly Agree) and mean scores will be calculated across items for each area.
After creating the fully functioning prototype (aim #2), the final aim is to pilot test the prototype with SMH providers serving 12- to 17-year-old students to ensure the product components function as intended and to gather preliminary evidence of the potential value and benefits of the Assist-MH product for supporting SMH service delivery. Using the same recruitment methods described in Aim #1, investigators will nationally recruit and randomly select 40 SMH providers. To participate, providers must provide SMH services to 12- to 17-year-old students. Once accepted into the study, the PI will conduct a brief webinar to review research methods and train providers in Assist-MH. Providers will then use Assist-MH as part of their SMH services for at least 2 weeks with at least 3 students. Providers will be responsible for obtaining parent consent for students to use Assist-MH and evaluate their experience via their provider; no identifying student information will be entered into the system (i.e., tracked by ID). Usage data will be collected by the software to determine prototype use amounts, including time spent for specific tasks and number of times each component is accessed. The system will also collect provider and student interactions with treatment strategies. 3C will also track number and type of technical assistance (TA) requests during the pilot test period (e.g., phone and email requests to technical support staff). The following set of measures will be collected before and after the trial period. Each measure is supported by prior studies showing internal consistency, reliability, and content validity with providers. For provider outcomes, investigators will assess three areas found to be associated with the quality of care among MH providers, and which investigators expect to change as a function of access to Assist-MH: Perceived Quality of Care scale, Self-efficacy (via Comfort and Skills survey), and Emotional Exhaustion subscale of the Human Service Provider version of the Maslach Burnout Inventory. Lastly, providers will rate their experiences with the prototype. Ratings will be made on a 5-pt scale (1=Strongly Disagree to 5=Strongly Agree) to assess each component and the overall prototype in each of the following areas: usability (e.g., user friendly, easy to navigate, engaging), feasibility (e.g., time efficient, doable), and value (e.g., quality, innovation, effectiveness for intended purpose). Providers will also ask students questions to report on their experiences using the prototype. Mean scores will be calculated across items for each area. Open-ended questions will also be included to gather qualitative comments and recommendations.
- Conditions
- Mental Health Strategies, School Mental Health Services, Digital Technologies, Technology Development
- Being tested
- ASSIST-MH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASSIST-MHOther
The goal of this SBIR is to create Assist-MH, a new interactive digital support system for SMH providers. Assist-MH will offer an innovative suite of diverse MH strategies to help providers address the clinical needs of youth in distress. In Phase I, the focus will be on tools to address depression and anxiety for students ages 12 to 17 years. These MH problems are among the most common for youth, and have shown increasing prevalence in recent years among this age group. Investigators will conduct user-centered testing to determine the set of MH strategies most needed by SMH providers, create a sampling of these resources, and test the usability and promise of the proposed Assist-MH product prior to Phase II full development and pilot testing.
| Study group | Role | What they receive |
|---|---|---|
| ASSIST-MH | Experimental | Participants in the pilot test will complete the same study tasks as others in their respective group: one group for providers and one group for students. All providers will (a) attend a brief webinar to review research methods and be trained to use Assist-MH, (b) use Assist-MH for at least 2 weeks with at least 3 students, (c) obtain parent consent for students to use Assist-MH as part of their regular school services, (d) complete pre \& post provider outcomes measures, and (e) rate their experiences with the prototype. All students will (a) use Assist-MH, (b) rate their experiences with the prototype via a provider survey. Receives: Other: ASSIST-MH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot prototype evaluation
Providers will rate their experiences with the prototype. Ratings will be made on a 5-pt scale (1=Strongly Disagree to 5=Strongly Agree) to assess each component and the overall prototype in each of the following areas: usability (e.g., user friendly, easy to navigate, engaging), feasibility (e.g., time efficient, doable), and value (e.g., quality, innovation, effectiveness for intended purpose). The 24 items will be computed into a summary score ranging from 1-5 to reflect mean ratings. A higher rating indicates stronger support for the Assist-MH product. Providers will ask students who participated in reviewing the strategies questions about their experience with the prototype. Providers will fill in their responses on the pilot prototype evaluation.
Measured: Within 1 week of study completion
Secondary outcomes (4)
Perceived Quality of Care scale
Will be used to measure providers' self-perception of the level of quality of care they provide to students. Providers rate 22 items on a 6-pt scale (1=Never to 6=Always) related to person-centered care (e.g., helped student meet personal/treatment goal) and discordant care (e.g., delayed response to requests, made mistakes). A mean score will be computed. Perceived quality of care score means range from 1 to 6. Higher mean score reflects higher perceived quality.
Measured: 2 months apart, as Pre- and Post-Test
Comfort & Skills survey
Will be used to assess providers' level of confidence and self-perceived skills with SMH treatment planning and delivery, such as "I know how to judge severity of student MH problems," "I can deliver services that help a student," and "I am confident in my ability to provide evidence-based care." Ratings are made on a 5-pt scale (1=Not true to 5=Very true). A mean score will be computed. Comfort and skill score means range from 1 to 5. Higher score reflects greater self-efficacy.
Measured: 2 months apart, as Pre- and Post-Test
Emotional Exhaustion subscale
Providers will complete the 9-item subscale of the Human Service Provider version of the Maslach Burnout Inventory (MBI-HSS). Providers rate how often they feel each item (e.g., "I feel emotionally drained from my work") on a 7-pt scale (1=Never to 7=Everyday). A mean score will be computed. Emotional Exhaustion score means range from 1 to 7. Higher scores indicate higher emotional exhaustion, a key component of burnout among MH providers.
Measured: 2 months apart, as Pre- and Post-Test
Provider Reported Student Usability ratings
Students will rate their experiences with the prototype. Ratings will be made on a 5-pt scale (1=Strongly Disagree to 5=Strongly Agree) to assess the usability of the Assist-MH prototype. The 4 items will be computed into a summary score ranging from 1-5 to reflect mean ratings. A higher rating indicates stronger support for the Assist-MH product.
Measured: Within 1 week of study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Apr 2025
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health StrategiesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants in the focus group will all be given the same set of study tasks. They will participate in a 60-minute virtual focus group and then rate the proposed Assist-MH product components. Participants in the pilot test will complete the same study tasks as others in their respective group: one group for providers and one group for students. All providers will (a) attend a brief webinar to review research methods and be trained to use Assist-MH, (b) use Assist-MH for at least 2 weeks with at least 3 students, (c) obtain parent consent for students to use Assist-MH as part of their regular school services, (d) complete pre \& post provider outcomes measures, and (e) rate their experiences with the prototype. All students will (a) use Assist-MH, (b) rate their experiences with the prototype via the provider survey.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3-C Institute for Social Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Melissa E DeRosier, PhD, Principal investigator, 3-C Institute for Social Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728683
- Sponsor's protocol ID
- ASSIST MH PI
- Other IDs
- 1R43MH138260-01
- Acronym
- ASSIST-MH
- Status last verified
- Jan 2026
- First submitted
- 22 Nov 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assist MH Digital Technologies to Support School Mental Health Care
- ClinicalTrials.gov ID
- NCT06728683
- Acronym / sponsor ID
- ASSIST-MH / ASSIST MH PI
- Conditions
- Mental Health Strategies, School Mental Health Services, Digital Technologies, Technology Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- 3-C Institute for Social DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 11 Dec 2024 (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 SBIR is to develop and test Assist-MH, a new interactive digital support system for SMH providers. Assist-MH will offer SMH treatment resources to help providers implement a more customized treatment plan specific to the student's needs. Based on student areas of need, the system will deliver both provider-led MH strategies to optimize time spent with the student and self-paced digital strategies (video, game-based, interactive) for students to augment in-person treatment and provide unique between-session learning and practice.
Detailed description
This 12-month Phase I project will accomplish three specific objectives: (1) conduct iterative testing with SMH providers, (2) create the fully functioning Assist-MH software prototype, and (3) pilot test the prototype with SMH providers (and their students). The first aim is to gather input from key stakeholders. From those who volunteer, investigators will randomly select 36 participants: 12 providers, 12 supervisors, and 12 administrators. To support diversity and generalizability of initial stakeholder feedback, investigators will stratify random selection to obtain equal participation by gender and 50% non-White participation which is expected to approximate 26% Black, 13% Asian American, and 11% multi-racial or other minority subgroup, with 12% of reporting Latinx/Hispanic ethnicity. Following random selection and consenting, stakeholders will participate in a 60-minute virtual focus group (separately by stakeholder type, 6-8 per group). In a semi-structured fashion, the PI will present initial design concepts and examples for each product component. Focus group discussions will be designed to identify pain points and barriers faced by SMH staff and opportunities to lower barriers to SMH service delivery as well as to gather specific recommendations. Following group participation, stakeholders will rate the value (innovation, usefulness, need), feasibility (time efficient, cost efficient, doable), and acceptability (quality of content, accessibility, scope) of the proposed Assist-MH product components. Ratings will be made on a 5-point scale from 1 (Strongly Disagree) to 5 (Strongly Agree) and mean scores will be calculated across items for each area.
After creating the fully functioning prototype (aim #2), the final aim is to pilot test the prototype with SMH providers serving 12- to 17-year-old students to ensure the product components function as intended and to gather preliminary evidence of the potential value and benefits of the Assist-MH product for supporting SMH service delivery. Using the same recruitment methods described in Aim #1, investigators will nationally recruit and randomly select 40 SMH providers. To participate, providers must provide SMH services to 12- to 17-year-old students. Once accepted into the study, the PI will conduct a brief webinar to review research methods and train providers in Assist-MH. Providers will then use Assist-MH as part of their SMH services for at least 2 weeks with at least 3 students. Providers will be responsible for obtaining parent consent for students to use Assist-MH and evaluate their experience via their provider; no identifying student information will be entered into the system (i.e., tracked by ID). Usage data will be collected by the software to determine prototype use amounts, including time spent for specific tasks and number of times each component is accessed. The system will also collect provider and student interactions with treatment strategies. 3C will also track number and type of technical assistance (TA) requests during the pilot test period (e.g., phone and email requests to technical support staff). The following set of measures will be collected before and after the trial period. Each measure is supported by prior studies showing internal consistency, reliability, and content validity with providers. For provider outcomes, investigators will assess three areas found to be associated with the quality of care among MH providers, and which investigators expect to change as a function of access to Assist-MH: Perceived Quality of Care scale, Self-efficacy (via Comfort and Skills survey), and Emotional Exhaustion subscale of the Human Service Provider version of the Maslach Burnout Inventory. Lastly, providers will rate their experiences with the prototype. Ratings will be made on a 5-pt scale (1=Strongly Disagree to 5=Strongly Agree) to assess each component and the overall prototype in each of the following areas: usability (e.g., user friendly, easy to navigate, engaging), feasibility (e.g., time efficient, doable), and value (e.g., quality, innovation, effectiveness for intended purpose). Providers will also ask students questions to report on their experiences using the prototype. Mean scores will be calculated across items for each area. Open-ended questions will also be included to gather qualitative comments and recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants in the focus group will all be given the same set of study tasks. They will participate in a 60-minute virtual focus group and then rate the proposed Assist-MH product components. Participants in the pilot test will complete the same study tasks as others in their respective group: one group for providers and one group for students. All providers will (a) attend a brief webinar to review research methods and be trained to use Assist-MH, (b) use Assist-MH for at least 2 weeks with at least 3 students, (c) obtain parent consent for students to use Assist-MH as part of their regular school services, (d) complete pre \& post provider outcomes measures, and (e) rate their experiences with the prototype. All students will (a) use Assist-MH, (b) rate their experiences with the prototype via the provider survey.
| Arm | Type | Receives |
|---|---|---|
| ASSIST-MH | Experimental | Other: ASSIST-MHParticipants in the pilot test will complete the same study tasks as others in their respective group: one group for providers and one group for students. All providers will (a) attend a brief webinar to review research methods and be trained to use Assist-MH, (b) use Assist-MH for at least 2 weeks with at least 3 students, (c) obtain parent consent for students to use Assist-MH as part of their regular school services, (d) complete pre \& post provider outcomes measures, and (e) rate their experiences with the prototype. All students will (a) use Assist-MH, (b) rate their experiences with the prototype via a provider survey. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- must be a SMH provider (providing services to 12- to 17-year-old students) or a student (12 to 17 years old)
- must have access to internet
- must be English language proficient.
- No one will be excluded based on gender, race, or ethnic background.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ASSIST-MHThe goal of this SBIR is to create Assist-MH, a new interactive digital support system for SMH providers. Assist-MH will offer an innovative suite of diverse MH strategies to help providers address the clinical needs of youth in distress. In Phase I, the focus will be on tools to address depression and anxiety for students ages 12 to 17 years. These MH problems are among the most common for youth, and have shown increasing prevalence in recent years among this age group. Investigators will conduct user-centered testing to determine the set of MH strategies most needed by SMH providers, create a sampling of these resources, and test the usability and promise of the proposed Assist-MH product prior to Phase II full development and pilot testing. | Other | ASSIST-MH |
Primary outcome
Pilot prototype evaluation
Time frame: Within 1 week of study completion
Providers will rate their experiences with the prototype. Ratings will be made on a 5-pt scale (1=Strongly Disagree to 5=Strongly Agree) to assess each component and the overall prototype in each of the following areas: usability (e.g., user friendly, easy to navigate, engaging), feasibility (e.g., time efficient, doable), and value (e.g., quality, innovation, effectiveness for intended purpose). The 24 items will be computed into a summary score ranging from 1-5 to reflect mean ratings. A higher rating indicates stronger support for the Assist-MH product. Providers will ask students who participated in reviewing the strategies questions about their experience with the prototype. Providers will fill in their responses on the pilot prototype evaluation.
4 secondary outcomes
Perceived Quality of Care scale
Time frame: 2 months apart, as Pre- and Post-Test
Comfort & Skills survey
Time frame: 2 months apart, as Pre- and Post-Test
Emotional Exhaustion subscale
Time frame: 2 months apart, as Pre- and Post-Test
Provider Reported Student Usability ratings
Time frame: Within 1 week of study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Melissa E DeRosier, PhD principal investigator
3-C Institute for Social Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASSIST-MH in people with Mental Health Strategies and School Mental Health Services, run by 3-C Institute for Social Development 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 4 inclusion and 0 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: finished, as of the sponsor's last update on 22 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pilot prototype evaluation (time frame: Within 1 week of study completion). 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 22 Jan 2026.