Assist MH Digital Technologies to Support School Mental Health Care

NCT ID: NCT06728683

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-07-18

Brief 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. 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.

Conditions

Technology Development; Mental Health Strategies; School Mental Health Services; Digital Technologies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASSIST-MH

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.

Group Type: EXPERIMENTAL

ASSIST-MH

Intervention Type: OTHER

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.

Interventions

ASSIST-MH

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

3-C Institute for Social Development

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa E DeRosier, PhD

Role: PRINCIPAL_INVESTIGATOR

3-C Institute for Social Development

Locations

3-C Institute for Social Development, Inc

Durham, North Carolina, United States

Countries

United States

Other Identifiers

1R43MH138260-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ASSIST MH PI

Identifier Type: -

Identifier Source: org_study_id