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Completed

NCT Number: NCT05466929

Engagement With Digital Mental Health (DMH) Technologies in Pediatric Primary Care

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 in families from underserved communities.

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Key information

Conditions

Mental Health Behavior Personal Satisfaction Psychological Well-Being

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center, Chicago, Illinois, United States

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About this study

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:

  • 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)
  • 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
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Are receiving care at specified Rush University Health System and University of Illinois at Chicago Pediatric Primary Care locations
  • Are between 13-17 years of age
  • Are able to speak and read in English
  • Symptoms of anxiety disorder

Exclusion criteria

  • Absence of the above inclusion criteria.

Treatment and study plan

TeACH System Resources

Behavioral

Patients who screen positive for anxiety will receive psychoeducation and mental health recommendations (e.g., evidence-based apps) selected for use with the TeACH System through a collaborative, stakeholder-engaged approach completed in phases 1 and 2 of this project.

Primary outcomes

  1. Anxiety Understanding: Baseline

    Time frame: Administered following assent (in case of participant attrition through the interaction)

    1 item (Likert Scale); We will ask participants to rate their understanding of anxiety on a Likert scale (1-5; 1 being "Not at All" and 5 being "Completely"). Specifically: "I understand what anxiety is."

  2. Anxiety Understanding: Post Interaction

    Time frame: Administered immediately after receiving randomized feedback/resources

    1 item (Likert Scale); We will ask participants to rate their understanding of anxiety on a Likert scale (1-5; 1 being "Not at All" and 5 being "Completely"). Specifically: "I understand what anxiety is."

  3. Anxiety Understanding: Maintenance

    Time frame: Administered one week after interaction with TeACH System

    1 item (Likert Scale); We will ask participants to rate their understanding of anxiety on a Likert scale (1-5; 1 being "Not at All" and 5 being "Completely"). Specifically: "I understand what anxiety is."

  4. Confidence to Act: Baseline

    Time frame: Administered following assent (in case of participant attrition through the interaction)

    1 item (Likert Scale); We will ask participants to rate how confident they feel to take action to help their anxiety symptoms on a Likert scale (1-5; 1 being "Not at All" to 5 being "Completely"). Specifically: "I feel confident I can do something if I feel anxiety."

  5. Confidence to Act: Post Interaction

    Time frame: Administered immediately after receiving randomized feedback/resources

    1 item (Likert Scale); We will ask participants to rate how confident they feel to take action to help their anxiety symptoms on a Likert scale (1-5; 1 being "Not at All" to 5 being "Completely"). Specifically: "I feel confident I can do something if I feel anxiety."

  6. Confidence to Act: Maintenance

    Time frame: Administered one week after interaction with TeACH System

    1 item (Likert Scale); We will ask participants to rate how confident they feel to take action to help their anxiety symptoms on a Likert scale (1-5; 1 being "Not at All" to 5 being "Completely"). Specifically: "I feel confident I can do something if I feel anxiety."

  7. Likelihood of using DMH for Anxiety: Baseline

    Time frame: Administered following assent (in case of participant attrition through the interaction)

    1 item (Likert Scale); We will ask participants to rate how likely they are to use digital mental health tools for their anxiety on a Likert scale (1-5; 1 being "Never" to 5 being "Absolutely"). Specifically: "If I feel anxiety, I would use a digital tool to help (app, website, reel/video)."

  8. Likelihood of using DMH for Anxiety: Post Interaction

    Time frame: Administered immediately after receiving randomized feedback/resources

    1 item (Likert Scale); We will ask participants to rate how likely they are to use digital mental health tools for their anxiety on a Likert scale (1-5; 1 being "Never" to 5 being "Absolutely"). Specifically: "If I feel anxiety, I would use a digital tool to help (app, website, reel/video)."

  9. Likelihood of using DMH for Anxiety: Maintenance

    Time frame: Administered one week after interaction with TeACH System

    1 item (Likert Scale); We will ask participants to rate how likely they are to use digital mental health tools for their anxiety on a Likert scale (1-5; 1 being "Never" to 5 being "Absolutely"). Specifically: "If I feel anxiety, I would use a digital tool to help (app, website, reel/video)."

  10. DMH use for Anxiety: Baseline

    Time frame: Administered following assent (in case of participant attrition through the interaction)

    1 item (Yes/No/Unsure); We will ask participants to report if they have used digital mental health tools for their anxiety symptoms. Specifically: "I have used a digital tool to help with anxiety (app, website, reel/video)."

  11. DMH use for Anxiety: Post Interaction

    Time frame: Administered immediately after receiving randomized feedback/resources

    1 item (Yes/No/Unsure); We will ask participants to report if they have used digital mental health tools for their anxiety symptoms. Specifically: "I have used a digital tool to help with anxiety (app, website, reel/video)."

  12. DMH use for Anxiety: Maintenance, Change in DMH Use Following TeACH System Interaction

    Time frame: Administered one week after interaction with TeACH System

    1 item (Yes/No/Unsure); We will ask participants to report if they have used digital mental health tools for their anxiety symptoms. Specifically: "I have used a digital tool to help with anxiety (app, website, reel/video)."

  13. Enrollment

    Time frame: Through study completion, an average of once per year.

    We will track the number of teens who use the TeACH System during implementation phases and will compare this to the number of teens who were eligible but did not use the system.

Secondary outcomes

  1. Kiddie-Computerized Adaptive Tests (K-CAT) Anxiety Module

    Time frame: Administered immediately after initiating use of the TeACH System; teen participants complete only once.

    <1 minute to complete; Uses item response theory to pull from a large question item bank to accurately diagnose anxiety symptom severity.

  2. After-Scenario Questionnaire (ASQ): Post Interaction

    Time frame: Administered immediately after receiving randomized feedback/resources from TeACH System

    3-item tool with seven response options (1-Strongly Disagree to 7-Strongly Agree) to assess satisfaction

  3. After-Scenario Questionnaire (ASQ): Maintenance

    Time frame: Administered one week after interaction with TeACH System

    3-item tool with seven response options (1-Strongly Disagree to 7-Strongly Agree) to assess satisfaction

Other outcomes

  1. Demographics

    Time frame: Administered immediately after initiating use of the TeACH System; teen participants complete only once.

    Name, date of birth, ethnicity, race, pronouns, gender, preferred language, reason for visiting primary care today, preferred channel of contact (i.e., text or email for follow-up)

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

Supporting Mental Health in Underserved Youth: Engagement With Digital Mental Health Technologies in Pediatric Primary Care

Acronym: TeACH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2022
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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