Digital Mental Health Technologies for Pediatric Mental Health

(TeACH Trial)

Recruiting at 1 trial location

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Others

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

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment TeACH System Resources, Teen Assess, Check, and Heal System for pediatric mental health?

Digital health interventions have shown promise in supporting mental health in young people by improving engagement and outcomes, although challenges remain in their implementation and consistent use. The potential of digital technology to integrate preventive and clinical interventions at scale suggests that treatments like the TeACH System could be effective if these challenges are addressed. ^{1 2 3 4 5}

Is the digital mental health technology safe for children and adolescents?

The available research does not provide specific safety data for the digital mental health technologies mentioned, but it highlights concerns about the lack of technical and medical standards, clinical validation, and data privacy in digital mental health tools for young people. ^{6 7 8 9 10}

How does the digital mental health treatment for pediatric mental health differ from other treatments?

This digital mental health treatment is unique because it uses mobile and internet-based applications to enhance engagement and accessibility for young people, making it more scalable and cost-efficient compared to traditional face-to-face therapies. It leverages technology to extend the reach of mental health services, which is particularly beneficial for adolescents who are familiar with digital tools and may not have access to formal help. ^{11 12 13 14 15}

What is the purpose of this trial?

The goal of this study is to use and adapt existing digital mental health technologies to advance the engagement, assessment, detection, treatment, and delivery of services for pediatric mental health. Specifically, user-centered design methodologies and an implementation science framework will be used to guide the development and implementation of the Teen Assess, Check, and Heal (TeACH) System into a pediatric primary care clinic serving teens and families from underserved communities. Study objectives include: 1. Collaborating with underserved teens and their parents to identify strategies to target top barriers to engagement as well as top ethical concerns and requirements for cultural relevance, usability, and usefulness of the TeACH System (Phase 1) 2. Refining the plan for implementing the TeACH System through observations, interviews, and co-design workshops with pediatric primary care pediatricians and staff (Phase 2), and 3. Implementing the TeACH System into a primary care clinics and evaluating it in a randomized trial. (Phase 3) The team will measure engagement outcomes and satisfaction with the TeACH System.

Eligibility Criteria

This trial is for teens aged 13-17 with symptoms of anxiety disorder, who are getting care at certain Rush University Health System and University of Illinois at Chicago Pediatric Primary Care clinics. They must be able to speak and read English. Teens not meeting these criteria cannot participate.

Inclusion Criteria

Patients are receiving care at specified Rush University Health System and University of Illinois at Chicago Pediatric Primary Care locations

Patients are able to speak and read in English

I experience symptoms of anxiety.

Exclusion Criteria

Absence of the above inclusion criteria.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Engagement Strategy Development

Collaborating with underserved teens and their parents to identify strategies to target top barriers to engagement as well as top ethical concerns and requirements for cultural relevance, usability, and usefulness of the TeACH System

4-6 weeks

Phase 2: Implementation Plan Refinement

Refining the plan for implementing the TeACH System through observations, interviews, and co-design workshops with pediatric primary care pediatricians and staff

4-6 weeks

Phase 3: System Implementation and Evaluation

Implementing the TeACH System into primary care clinics and evaluating it in a randomized trial

12 weeks

Follow-up

Participants are monitored for engagement outcomes and satisfaction with the TeACH System

4 weeks

Treatment Details

Interventions

• TeACH System Resources

Trial Overview The study tests the TeACH System, a digital mental health technology designed for pediatric mental health care. It involves collaboration with teens and parents (Phase 1), refining the system with healthcare staff (Phase 2), and evaluating it in a randomized trial within primary care clinics (Phase 3).

Participant Groups

Group I: TeACH System Resources Experimental Treatment 1 Intervention

Patients who screen positive for anxiety will receive stakeholder-informed feedback and resources (i.e., psychoeducation and mental health recommendations).

Group II: Evidence-based Resources Active Control 1 Intervention

Patients who screen positive for anxiety will receive a link to a webpage providing psychoeducation about anxiety and possible treatment options.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Findings from Research

Project YES, a culturally adapted digital mental health platform, was successfully implemented in San Antonio, with a completion rate of 49.64% among youths, which is higher than previous rates observed when disseminated via social media.

Participants reported significant improvements in mental health outcomes, such as reduced hopelessness and self-hate, indicating that the platform is an effective and acceptable resource for both English- and Spanish-speaking youths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Digital Single-Session Intervention Platform for Youth Mental Health: Cultural Adaptation, Evaluation, and Dissemination. Shroff, A., Roulston, C., Fassler, J., et al.[2023]

Digital technology has the potential to significantly improve mental health outcomes by integrating preventive and clinical interventions into healthcare systems, allowing for scalable solutions to reduce mental health disorders.

To effectively harness this potential, the establishment of outcome optimization teams is proposed, which would utilize data analytics to adapt interventions and enhance their reach, uptake, and overall effectiveness, particularly in addressing issues like eating disorders in young populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Digital Technology to Reduce the Prevalence of Mental Health Disorders in Populations: Time for a New Approach. Taylor, CB., Ruzek, JI., Fitzsimmons-Craft, EE., et al.[2022]

The feasibility trial involved 270 young people, with 142 successfully recruited, indicating a good level of engagement for testing the Power Up app designed to enhance patient activation and shared decision-making in mental health.

Post-trial interviews revealed that young users found the Power Up app acceptable and motivating, suggesting it could be effectively integrated into mental health management for young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Trial of Power Up: Smartphone App to Support Patient Activation and Shared Decision Making for Mental Health in Young People. Edbrooke-Childs, J., Edridge, C., Averill, P., et al.[2023]

This systematic review analyzed 25 studies on digital health interventions (DHIs) for mental disorders in youth, identifying cognitive and affective mediators as key factors influencing intervention outcomes, with 100% of affective mediators showing significant effects.

Despite the promising findings, most studies lacked the ability to draw causal conclusions, highlighting the need for improved research designs to better understand how DHIs work and enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of Change in Digital Health Interventions for Mental Disorders in Youth: Systematic Review. Domhardt, M., Engler, S., Nowak, H., et al.[2021]

Digital mental health interventions (DMHIs) have great potential to improve mental health treatment, but most have not been rigorously tested and often lack adherence to evidence-based practices.

There is a significant gap in training for clinicians on how to effectively integrate these technological tools into their practice, highlighting both challenges and opportunities for improving mental health care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scaling evidence-based treatments through digital mental health. Schueller, SM., Torous, J.[2021]

The myHealthE (MHE) system successfully automates the collection and reporting of Patient-Reported Outcome Measures (PROMs) for Child and Adolescent Mental Health Services, demonstrating feasibility and acceptability within NHS clinical services.

The paper outlines a framework for developing and implementing digital health innovations, addressing logistical and governance challenges, which can guide future researchers in creating interoperable systems within NHS infrastructure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving from development to implementation of digital innovations within the NHS: myHealthE, a remote monitoring system for tracking patient outcomes in child and adolescent mental health services. Morris, AC., Ibrahim, Z., Moghraby, OS., et al.[2023]

Digital health interventions, such as mobile apps and electronic health records, can enhance patient safety for children and their parents by providing preventive measures and risk management strategies, as identified in a scoping review of 13 studies.

These interventions can improve the continuity of care from hospitalization to home, thereby increasing children's safety and quality of care through better engagement with healthcare providers after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health intervention on patient safety for children and parents: A scoping review. Park, J., Jeon, H., Choi, EK.[2023]

A significant 66% of child and adolescent psychiatric inpatients owned smartphones, indicating a strong potential for integrating technology into mental health care.

While only 18% of patients downloaded the safety planning app 'Be Safe' before discharge, a majority expressed interest in doing so afterward, suggesting that introducing such tools earlier in their treatment could enhance their use and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Smartphone Technology at the Time of Discharge from a Child and Adolescent Inpatient Psychiatry Unit. Gregory, JM., Sukhera, J., Taylor-Gates, M.[2022]

Digital mental health tools have the potential to provide significant benefits for young people with mental health disorders, including improved assessment, support, and treatment options.

However, there are substantial ethical challenges and a lack of clinical validation for these tools, which may hinder their effective implementation in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Mental Health for Young People: A Scoping Review of Ethical Promises and Challenges. Wies, B., Landers, C., Ienca, M.[2021]

Mental health professionals recognize the need for digital adaptations in youth mental health care, but many lack formal training in digital psychiatry, which affects their confidence in delivering digital mental health interventions (DMHIs).

Training in DMHIs is associated with a greater perceived feasibility and efficacy of these interventions, suggesting that improving digital literacy among professionals could enhance the delivery of mental health care to young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of digital tools in providing youth mental health: results from an international multi-center study. Orsolini, L., Appignanesi, C., Pompili, S., et al.[2023]

The study involved qualitative data from focus groups and interviews with 32 stakeholders in youth mental health services, revealing concerns about the acceptability of digital technologies for engaging young clients.

Six key themes emerged, highlighting the importance of personal connection and professional identity, as well as the risks and challenges of integrating technology into mental health care for youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The promise and the reality: a mental health workforce perspective on technology-enhanced youth mental health service delivery. Orlowski, S., Lawn, S., Matthews, B., et al.[2018]

Out of 3806 mental health apps identified, only 15 (0.39%) met the criteria for targeting anxiety, depression, or PTSD in youth, indicating a significant lack of quality options available for young users.

The overall quality of the eligible apps was moderate, with a mean score of 3.59 on the Mobile App Rating Scale, and only one app had been evaluated in a randomized controlled trial, highlighting the need for more rigorous scientific evaluation and development of mental health apps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile-based interventions for common mental disorders in youth: a systematic evaluation of pediatric health apps. Domhardt, M., Messner, EM., Eder, AS., et al.[2021]

Digital mental health technologies can significantly improve access to mental health support for adolescents suffering from depression and anxiety, especially in low- and middle-income countries where traditional services may be limited.

The review highlights the importance of integrating these technologies into various settings, particularly in response to the increased mental health challenges faced by young people during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital technologies to support adolescents with depression and anxiety: review. Bevan Jones, R., Hussain, F., Agha, SS., et al.[2023]

Clinicians working with young people identified that digital mental health tools, like mood-tracking apps and web-based videos, can enhance engagement and skill-building in treatment, but they also face challenges such as accessibility and content limitations.

The study highlights the need for a centralized digital platform that connects clinicians, young clients, and caregivers, emphasizing the importance of setting clear expectations and providing human support when integrating these tools into mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of Digital Tools Into Community Mental Health Care Settings That Serve Young People: Focus Group Study. Knapp, AA., Cohen, K., Nicholas, J., et al.[2021]

Providers believe that technology can significantly improve the delivery of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for adolescents, based on qualitative interviews with nine experienced providers.

A survey of 56 TF-CBT experts highlighted the need for a mobile app and a dedicated website to provide resources, suggesting that these technological tools could enhance treatment engagement and effectiveness for youth dealing with trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the Delivery of an Empirically-Supported Trauma-Focused Treatment for Adolescents: Providers' Views of the Role of Technology and Web-Based Resources. Orengo-Aguayo, RE., Hanson, RF., Moreland, AD., et al.[2021]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A Digital Single-Session Intervention Platform for Youth Mental Health: Cultural Adaptation, Evaluation, and Dissemination. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Using Digital Technology to Reduce the Prevalence of Mental Health Disorders in Populations: Time for a New Approach. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

A Feasibility Trial of Power Up: Smartphone App to Support Patient Activation and Shared Decision Making for Mental Health in Young People. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Mechanisms of Change in Digital Health Interventions for Mental Disorders in Youth: Systematic Review. [2021]

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

Scaling evidence-based treatments through digital mental health. [2021]

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

Moving from development to implementation of digital innovations within the NHS: myHealthE, a remote monitoring system for tracking patient outcomes in child and adolescent mental health services. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Digital health intervention on patient safety for children and parents: A scoping review. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Integrating Smartphone Technology at the Time of Discharge from a Child and Adolescent Inpatient Psychiatry Unit. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Mental Health for Young People: A Scoping Review of Ethical Promises and Challenges. [2021]

10. England pubmed.ncbi.nlm.nih.gov

The role of digital tools in providing youth mental health: results from an international multi-center study. [2023]

11. England pubmed.ncbi.nlm.nih.gov

The promise and the reality: a mental health workforce perspective on technology-enhanced youth mental health service delivery. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Mobile-based interventions for common mental disorders in youth: a systematic evaluation of pediatric health apps. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Digital technologies to support adolescents with depression and anxiety: review. [2023]

14. Canada pubmed.ncbi.nlm.nih.gov

Integration of Digital Tools Into Community Mental Health Care Settings That Serve Young People: Focus Group Study. [2021]

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

Enhancing the Delivery of an Empirically-Supported Trauma-Focused Treatment for Adolescents: Providers' Views of the Role of Technology and Web-Based Resources. [2021]