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

Disqualifiers: Non-SMH providers, Non-English speakers, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test Assist-MH, a new digital support system designed to help school mental health (SMH) providers create personalized treatment plans for students. The system combines provider-guided strategies with interactive, self-paced tools like videos and games to enhance student learning and practice between sessions. The trial seeks feedback from SMH providers and students on the system's effectiveness in improving mental health support. Suitable participants include SMH providers working with students aged 12-17 and students in that age group who have internet access and speak English.

As an unphased trial, this study allows participants to contribute to innovative mental health solutions in educational settings.

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 prior data suggests that this digital support system is safe for school mental health providers and students?

Research has shown that digital tools like Assist-MH can be evaluated for safety. However, specific safety data for Assist-MH itself is not yet available. As a digital support tool, Assist-MH offers help and strategies rather than direct medical treatments, making it typically safer and easier to use than medications or surgeries. Participants using Assist-MH will engage in activities such as webinars and online group discussions, which generally pose low risk. For any concerns, discussing them with the trial team is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Assist-MH digital support system because it offers a fresh approach to enhancing school counseling. Unlike traditional face-to-face counseling sessions, Assist-MH leverages digital tools to provide continuous support and feedback for both students and providers. This system not only makes counseling more accessible by allowing virtual interactions, but it also empowers students to engage actively in their mental health journey by providing them with user-friendly, interactive resources. By integrating technology into mental health support, Assist-MH aims to improve engagement and outcomes, making it a promising development in the field of school counseling.

What evidence suggests that Assist-MH is effective for school counseling?

Research has shown that mental health programs in schools can improve students' mental health. One study found that group activities and one-on-one counseling in schools boosted students' well-being. In this trial, Assist-MH, the digital support system being tested, builds on this idea by offering personalized mental health strategies for students. It combines in-person activities with digital tools like videos and games to help students learn and practice between sessions. By creating plans tailored to each student's needs, it aims to improve mental health and provide ongoing support. This approach could make mental health services more accessible and offer timely help. ^{1 6 7 8 9}

Who Is on the Research Team?

Melissa E DeRosier, PhD

Principal Investigator

3-C Institute for Social Development

Are You a Good Fit for This Trial?

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

Must have access to internet

Must be English language proficient

I am a provider for students aged 12-17 or a student in that age range.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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