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

NCT05466929 | Completed DMC

• 1 other identifier: K08MH125069
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Mental Health

Keywords

Digital Mental Health Technology; Digital Mental Health; Mental Health Disorders; Mental Health Wellness

Outcome Measures

Primary Outcomes (13)

• 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

• 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.

Secondary Outcomes (3)

• Kiddie-Computerized Adaptive Tests (K-CAT) Anxiety Module

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

• After-Scenario Questionnaire (ASQ): Post Interaction

  Administered immediately after receiving randomized feedback/resources from TeACH System

• After-Scenario Questionnaire (ASQ): Maintenance

  Administered one week after interaction with TeACH System

Other Outcomes (1)

• Demographics

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

Study Arms (2)

TeACH System Resources

EXPERIMENTAL

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

Behavioral: TeACH System Resources

Evidence-based Resources

NO INTERVENTION

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

Interventions

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.

TeACH System Resources

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60601, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 39965196 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group (TeACH System psychoeducation and recommendations) and control group (evidence-based online educational materials)

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 20, 2022
• Study Start: July 16, 2024
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (2)