Clinical trial NCT06728683: Assist MH Digital Technologies to Support School Mental Health Care
Official title: Assist MH Digital Technologies to Support School Mental Health Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Strategies
School Mental Health Services
Digital Technologies
Technology Development
Lead sponsor: 3-C Institute for Social Development
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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 over a 2-month period with at least 3 students, (c) obtain parent consent for students to use Assist-MH and evaluate their experience, (d) complete pre \& post provider outcomes measures, and (e) rate their experiences with the prototype. All students will (a) use Assist-MH, (b) complete pre \& post student outcomes measures, and (c) rate their experiences with the prototype.
Primary purpose: TREATMENT

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 an innovative interactive planning tool to help providers create a treatment plan customized to the student's specific needs. Based on inputs, the system will generate 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. SMH providers will use Assist-MH to plan and assign individualized MH strategies as well as monitor student progress over time (completion and MH functioning).

Detailed description: This 12-month Phase I project will accomplish three specific objectives: (1) conduct focus groups 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 and their 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 and their supervisor must agree to provide oversight of their use of Assist-MH during the trial period. 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 over a 2-month period with at least 3 students. Providers will be responsible for obtaining parent consent for students to use Assist-MH and evaluate their experience; 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 inputs into the system, including survey responses, performance on practice exercises, including virtual simulations, and planning tool entries. 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. For student outcomes, investigators will assess three areas: MH symptoms and wellbeing (via PHQ-9 and GAD-7), Stigma (via Self-stigma of Seeking Help Scale), and Service engagement scale. Lastly, providers and 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 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). Mean scores will be calculated across items for each area. Open-ended questions will also be included to gather qualitative comments and recommendations.

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)
* if they are a SMH provider, have their supervisor agree to provide oversight of their use of Assist-MH during the trial period
* must have access to internet
* must be English language proficient.
* No one will be excluded based on gender, race, or ethnic background.

Primary outcomes:
measure: Focus group prototype evaluation
timeFrame: Within 1 week of study completion
measure: Pilot prototype evaluation
timeFrame: Within 1 week of study completion
Secondary outcomes:
measure: Perceived Quality of Care scale
timeFrame: 2 months apart, as Pre- and Post-Test
measure: Comfort & Skills survey
timeFrame: 2 months apart, as Pre- and Post-Test
measure: Emotional Exhaustion subscale
timeFrame: 2 months apart, as Pre- and Post-Test
measure: PHQ-9 (Patient Health Questionnaire)
timeFrame: 2 months apart, as Pre- and Post-Test
measure: GAD-7 (Generalized Anxiety Disorder)
timeFrame: 2 months apart, as Pre- and Post-Test
measure: Students' Life Satisfaction scale
timeFrame: 2 months apart, as Pre- and Post-Test
measure: Self-stigma of Seeking Help (SSOSH)
timeFrame: 2 months apart, as Pre- and Post-Test
measure: Service Engagement survey
timeFrame: 2 months apart, as Pre- and Post-Test
Other outcomes:
Locations:
city: Durham
country: United States
facility: 3-C Institute for Social Development, Inc
state: North Carolina
Study officials:
affiliation: 3-C Institute for Social Development
name: Melissa E DeRosier, PhD
role: PRINCIPAL_INVESTIGATOR
References: