Assist MH Digital Technologies to Support School Mental Health Care

NCT06728683 | Completed

• 2 other identifiers: ASSIST MH PI1R43MH138260-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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.

  Within 1 week of study completion

Secondary Outcomes (4)

• Perceived Quality of Care scale

  2 months apart, as Pre- and Post-Test

• Comfort & Skills survey

  2 months apart, as Pre- and Post-Test

• Emotional Exhaustion subscale

  2 months apart, as Pre- and Post-Test

• Provider Reported Student Usability ratings

  Within 1 week of study completion

Study Arms (1)

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.

Other: ASSIST-MH

Interventions

ASSIST-MH 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.

ASSIST-MH

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• 3-C Institute for Social Development: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

3-C Institute for Social Development, Inc

Durham, North Carolina, 27713, United States

Location

Study Officials

• Melissa E DeRosier, PhD

  3-C Institute for Social Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 11, 2024
• Study Start: April 1, 2025
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (1)