Digital Support System for School Counseling

(ASSIST-MH Trial)

Overseen By Melissa E DeRosier, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: 3-C Institute for Social Development

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Assist-MH in the Digital Support System for School Counseling?

Research on similar digital support systems, like the AI chatbot Tess, shows that these technologies can effectively engage adolescents and help them make progress toward their health goals, with 81% of participants reporting positive progress. This suggests that digital interventions can be beneficial in supporting mental health and behavior change in young people. ^{1 2 3 4 5}

Is the Digital Support System for School Counseling, also known as Assist-MH, safe for use in humans?

The research mentions a web-based system for tracking minor adverse events, which helps identify unexpected patterns and improve safety in clinical trials. This suggests that digital systems like Assist-MH can be monitored for safety, but specific safety data for Assist-MH itself is not provided. ^{6 7 8 9 10}

How does the treatment Assist-MH differ from other treatments for school counseling?

Assist-MH is unique because it is a digital support system designed to enhance school counseling by providing automated psychological care and mental health screening, making it easier to identify at-risk students and connect them with necessary support, unlike traditional face-to-face counseling methods. ^{11 12 13 14 15}

Research Team

Melissa E DeRosier, PhD

Principal Investigator

3-C Institute for Social Development

Eligibility Criteria

This trial is for school mental health (SMH) providers looking to enhance their treatment plans with digital support. It's suitable for those who want to integrate technology into therapy and counseling, especially for conditions like Text Neck and Carpal Tunnel Syndrome.

Inclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group

Conduct focus groups with SMH providers to gather input from key stakeholders and rate the proposed Assist-MH product components.

1 week

1 virtual focus group session

Prototype Development

Create the fully functioning Assist-MH software prototype based on focus group feedback.

6 months

Pilot Testing

Pilot test the prototype with SMH providers and their students to ensure functionality and gather preliminary evidence of the potential value and benefits.

2 months

Ongoing use with at least 3 students

Follow-up

Participants are monitored for outcomes such as perceived quality of care, self-efficacy, emotional exhaustion, and student mental health symptoms.

2 months

Treatment Details

Interventions

• Assist-MH

Trial Overview The trial is testing Assist-MH, an interactive digital system designed to aid SMH providers. It helps create personalized treatment plans with provider-led strategies and self-paced digital activities such as videos and games to support students' mental health.

Participant Groups

Group I: ASSIST-MH Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

3-C Institute for Social Development

Lead Sponsor

Trials

15

Recruited

2,300+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

The behavioral coaching chatbot Tess was successfully integrated into the counseling of 23 adolescent patients dealing with weight management and prediabetes, showing high engagement with 4,123 messages exchanged and 96% of users finding it helpful.

Adolescents reported positive progress toward their health goals 81% of the time, indicating that Tess effectively supported treatment adherence and behavior change, demonstrating the potential for BITs to enhance behavioral health interventions in pediatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of pediatric obesity and prediabetes treatment support through Tess, the AI behavioral coaching chatbot. Stephens, TN., Joerin, A., Rauws, M., et al.[2020]

A pilot study involving 22 adolescents and their parents showed that integrating a mobile app with family-focused therapy (FFT) led to significant improvements in depression scores over 27 weeks, indicating the potential efficacy of this approach.

Participants engaged with the app, completing 46%-65% of assessments and skill practices, and reported reduced parental criticism, suggesting that mobile apps can enhance treatment engagement and provide valuable feedback for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Open Trial of a Technology-Enhanced Family Intervention for Adolescents at Risk for Mood Disorders. Miklowitz, DJ., Weintraub, MJ., Posta, F., et al.[2022]

POD Adventures is a blended problem-solving game-based intervention designed for adolescents in India, developed through extensive stakeholder engagement and user-testing with 126 participants, including students and service providers.

The intervention aims to provide accessible mental health support through a gamified app, emphasizing relatability and interactivity, and will be evaluated in a randomized controlled trial to assess its effectiveness in low-resource school settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Development of the "POD Adventures" Smartphone Game: A Blended Problem-Solving Intervention for Adolescent Mental Health in India. Gonsalves, PP., Hodgson, ES., Kumar, A., et al.[2023]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

The Brazilian Portuguese version of the Pediatric Trigger Toolkit was successfully translated and adapted for use in Brazilian hospitals, involving a thorough validation process that included expert consensus and cultural adaptation.

The toolkit demonstrated a positive predictive value of 13.51% for identifying adverse drug events in pediatric patients, with antihistamine triggers being the most effective, indicating its potential utility in improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients. Silva, LT., Modesto, ACF., Martins, RR., et al.[2020]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

A review of pediatric psychopharmacology trials over the past 10 years revealed that only 11.8% utilized a data and safety monitoring board (DSMB), indicating a significant gap in safety monitoring practices for this vulnerable population.

Most trials relied on basic safety elicitation methods, such as laboratory tests and vital signs, with only 6% depending solely on spontaneous reporting of adverse events, highlighting the need for improved safety protocols in pediatric research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety methodology in pediatric psychopharmacology trials. Yuill, K., Carandang, C.[2013]

The SAFER Care framework, which includes standardized written and verbal discharge counseling, significantly improved caregiver comprehension of discharge instructions from 37% to 62% after implementation, based on surveys from 433 caregivers.

This study highlights the effectiveness of structured discharge counseling in a pediatric inpatient setting, suggesting that similar approaches could benefit other patient populations, especially those with limited English proficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAFER Care: Improving Caregiver Comprehension of Discharge Instructions. Uong, A., Philips, K., Hametz, P., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The utility of a caseload registry: perceptions of behavioral health clinicians working in an integrated primary care and mental health program. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility of pediatric obesity and prediabetes treatment support through Tess, the AI behavioral coaching chatbot. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Computer-supported monitoring of patient treatment response. [2015]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Development and Open Trial of a Technology-Enhanced Family Intervention for Adolescents at Risk for Mood Disorders. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Design and Development of the "POD Adventures" Smartphone Game: A Blended Problem-Solving Intervention for Adolescent Mental Health in India. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. [2009]

7. Brazil pubmed.ncbi.nlm.nih.gov

The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Safety methodology in pediatric psychopharmacology trials. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

SAFER Care: Improving Caregiver Comprehension of Discharge Instructions. [2022]

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School counselors' perceptions of virtual counseling in Lebanon: A qualitative study. [2023]

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