Assist MH Digital Technologies to Support School Mental Health Care

Not Applicable

Not yet recruiting

• Conditions: Mental Health Strategies; School Mental Health Services; Digital Technologies; Technology Development

• Registration Number: NCT06728683
• Lead Sponsor: 3-C Institute for Social Development

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.

Study Timeline

• Study First Submitted: 2024-11-22
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Study Start: 2025-04-01
• Primary Completion: 2025-07-18
• Study Completion: 2025-07-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Focus group prototype evaluation	Within 1 week of study completion	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.
Pilot prototype evaluation	Within 1 week of study completion	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).

Secondary Outcome Measures

Name	Time	Method
Perceived Quality of Care scale	2 months apart, as Pre- and Post-Test	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). Higher mean score reflects higher perceived quality.
Comfort & Skills survey	2 months apart, as Pre- and Post-Test	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) and a mean scale score is computed where higher score reflects greater self-efficacy.
Emotional Exhaustion subscale	2 months apart, as Pre- and Post-Test	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). Higher scores indicate higher emotional exhaustion, a key component of burnout among MH providers.
PHQ-9 (Patient Health Questionnaire)	2 months apart, as Pre- and Post-Test	Students will complete this 9-item survey about depression (e.g., "Feeling down, depressed, or hopeless", "Trouble concentrating on things") on a 4-pt scale (0="not at all" to 3="nearly every day"). A higher summed score indicates an increased severity of depression.
GAD-7 (Generalized Anxiety Disorder)	2 months apart, as Pre- and Post-Test	Students will complete this 7-item scale about anxiety (e.g., "Feeling nervous, anxious, or on edge", "Trouble relaxing") on a 4-pt scale (0="not at all" to 3="nearly every day"). A higher summed score indicates an increased severity of anxiety.
Students' Life Satisfaction scale	2 months apart, as Pre- and Post-Test	Students will complete the 7-item scale of general life satisfaction items (e.g., "I look forward to going to school", "My friends are nice to me") on a 6-pt scale from "Strongly Disagree" to "Strongly Agree". Mean scale scores will be calculated for each measure.
Self-stigma of Seeking Help (SSOSH)	2 months apart, as Pre- and Post-Test	Students will complete this 10-item scale to assess self-stigma on seeking help regardless of whether an individual has already been diagnosed with a mental illness or not. It consists of a 5-point Likert scale rated from "Strongly Disagree" to "Strongly Agree".
Service Engagement survey	2 months apart, as Pre- and Post-Test	Students will complete this 5-item survey rating their level of motivation to engage in MH treatment, likelihood of continuing services, and satisfaction with their MH treatment on a 5-pt scale (1=Not at all to 5=Very High). Investigators will also determine whether the student dropped out over the trial period. These items will be combined so that a higher score reflets greater service engagement.

Trial Locations

Locations (1)

3-C Institute for Social Development, Inc; 🇺🇸 Durham, North Carolina, United States