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

Supporting Mental Health in Underserved Youth: Engagement With Digital Mental Health 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.

Study Overview

• Status: Completed
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: TeACH System Resources

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 365
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60601
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TeACH System Resources; Patients who screen positive for anxiety will receive stakeholder-informed feedback and resources (i.e., psychoeducation and mental health recommendations).	Behavioral: TeACH System Resources; 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.
No Intervention: Evidence-based Resources; Patients who screen positive for anxiety will receive a link to a webpage providing psychoeducation about anxiety and possible treatment options.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment	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.	Through study completion, an average of once per year.
Anxiety Understanding: Baseline	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."	Administered following assent (in case of participant attrition through the interaction)
Anxiety Understanding: Post 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."	Administered immediately after receiving randomized feedback/resources
Anxiety Understanding: Maintenance	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."	Administered one week after interaction with TeACH System
Confidence to Act: Baseline	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."	Administered following assent (in case of participant attrition through the interaction)
Confidence to Act: Post 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."	Administered immediately after receiving randomized feedback/resources
Confidence to Act: Maintenance	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."	Administered one week after interaction with TeACH System
Likelihood of using DMH for Anxiety: Baseline	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)."	Administered following assent (in case of participant attrition through the interaction)
Likelihood of using DMH for Anxiety: Post 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)."	Administered immediately after receiving randomized feedback/resources
Likelihood of using DMH for Anxiety: Maintenance	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)."	Administered one week after interaction with TeACH System
DMH use for Anxiety: Baseline	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)."	Administered following assent (in case of participant attrition through the interaction)
DMH use for Anxiety: Post 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)."	Administered immediately after receiving randomized feedback/resources
DMH use for Anxiety: Maintenance, Change in DMH Use Following TeACH System 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)."	Administered one week after interaction with TeACH System

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kiddie-Computerized Adaptive Tests (K-CAT) Anxiety Module	<1 minute to complete; Uses item response theory to pull from a large question item bank to accurately diagnose anxiety symptom severity.	Administered immediately after initiating use of the TeACH System; teen participants complete only once.
After-Scenario Questionnaire (ASQ): Post Interaction	3-item tool with seven response options (1-Strongly Disagree to 7-Strongly Agree) to assess satisfaction	Administered immediately after receiving randomized feedback/resources from TeACH System
After-Scenario Questionnaire (ASQ): Maintenance	3-item tool with seven response options (1-Strongly Disagree to 7-Strongly Agree) to assess satisfaction	Administered one week after interaction with TeACH System

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	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)	Administered immediately after initiating use of the TeACH System; teen participants complete only once.

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: University of Illinois at Chicago

Publications and helpful links

General Publications

• Stiles-Shields C, Bobadilla G, Reyes K, Gustafson EL, Lowther M, Smith DL, Frisbie C, Antognini C, Dyer G, MacCarthy R, Martinengo N, Morris G, Touranachun A, Wilkens KM, Julion WA, Karnik NS. Digital Mental Health Screening, Feedback, and Referral System for Teens With Socially Complex Needs: Protocol for a Randomized Controlled Trial Integrating the Teen Assess, Check, and Heal System into Pediatric Primary Care. JMIR Res Protoc. 2025 Feb 18;14:e65245. doi: 10.2196/65245.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2024
• Primary Completion (Actual): November 6, 2025
• Study Completion (Actual): November 6, 2025

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Estimated): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 6, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Mental Health Disorders; Digital Mental Health; Digital Mental Health Technology; Mental Health Wellness
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• Other Study ID Numbers: K08MH125069 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No