Digital Mental Health Technologies for Pediatric Mental Health

(TeACH Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance mental health support for teens using digital tools. It focuses on assisting families from underserved communities by offering resources and feedback for anxiety treatment. Participants who screen positive for anxiety will receive educational materials and personalized recommendations through the TeACH System Resources (Teen Assess, Check, and Heal System). Teens aged 13-17 who receive care at specific clinics and exhibit anxiety symptoms are well-suited for this trial. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative mental health solutions tailored to their community.

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 prior data suggests that these digital mental health technologies are safe for pediatric use?

Research has shown that the TeACH System, a digital tool for mental health, helps teens with anxiety by providing feedback and resources. Studies have evaluated the system's effectiveness in offering mental health support. No major safety issues emerged in these studies, suggesting that the system is generally safe to use.

Although the current trial phase does not provide new safety information, the TeACH System's past use without serious problems is encouraging. This history makes it a potentially safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TeACH System Resources because it offers a personalized approach to managing pediatric anxiety. Unlike traditional treatments that often rely on generalized therapy or medication, TeACH provides customized feedback and recommendations based on the unique needs and experiences of each patient. This stakeholder-informed approach aims to increase engagement and effectiveness by making mental health resources more relatable and accessible for young patients. By tailoring support to the individual, TeACH has the potential to improve outcomes and better support children in managing their anxiety.

What evidence suggests that the TeACH System Resources are effective for pediatric mental health?

Research shows that the TeACH System, a treatment option in this trial, helps teens through quick check-ins, feedback, and resources for anxiety. Studies have found it effective in helping users understand and recognize anxiety better. The system provides personalized feedback and advice, aiding treatment choices. Early results suggest this digital tool can enhance mental health care for teens, especially in underserved areas, by making helpful information and resources more accessible. Another arm of this trial provides participants with evidence-based resources, offering psychoeducation about anxiety and possible treatment options. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11888113/

Digital Mental Health Screening, Feedback, and Referral ... This study aimed to evaluate the Teen Assess, Check, and Heal (TeACH) System in comparison to a control condition while integrated into PPCs.

2. researchprotocols.org researchprotocols.org/2025/1/e65245/

Digital Mental Health Screening, Feedback, and Referral ... The TeACH System is a DMH LIT that includes teen patient-facing brief assessment, feedback, and resources for symptoms of anxiety (sample ...

3. researchgate.net researchgate.net/publication/387125368_Digital_Mental_Health_Screening_Feedback_and_Referral_System_for_Teens_with_Socially_Complex_Needs_Protocol_for_a_Randomized_Controlled_Trial_Integrating_the_TeACH_System_into_Pediatric_Primary_Care_P

Digital Mental Health Screening, Feedback, and Referral ... Objective This study aimed to evaluate the Teen Assess, Check, and Heal (TeACH) System in comparison to a control condition while integrated ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2797219

Screening for Anxiety in Children and Adolescents: US ... The 2018-2019 National Survey of Children's Health (NSCH) found that 7.8% of children and adolescents aged 3 to 17 years had a current anxiety ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6526964/

Assessment and Treatment of Anxiety Among Children and ... This review focuses on the assessment and treatment of the following anxiety disorders among children and adolescents: generalized anxiety disorder (GAD), ...

6. childpsych.theclinics.com childpsych.theclinics.com/article/S1056-4993(21)00056-0/fulltext

Rating Scales for Behavioral Health Screening System ... Pediatric primary care professionals play a key role in identifying youth who would benefit from behavioral health services through universal screening.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11753843/

Pre-implementation determinants for digital mental health ... The study findings were intended as a first step to guide future implementation planning for the TeACH System, and serve as an example to inform ...