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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT06728683
Study groupRoleWhat they receive
ASSIST-MHExperimentalParticipants 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted11 Dec 2024
  2. Study start1 Apr 2025
  3. Primary completion18 Jul 2025
  4. Study completion18 Jul 2025

Resources

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)
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

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.

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