Skip to main content
Clinical Trials/NCT05466929
NCT05466929
Completed
N/A

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

Rush University Medical Center2 sites in 1 country365 target enrollmentJuly 16, 2024
ConditionsMental Health

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Health
Sponsor
Rush University Medical Center
Enrollment
365
Locations
2
Primary Endpoint
Anxiety Understanding: Baseline
Status
Completed
Last Updated
5 months ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
July 16, 2024
End Date
November 6, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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."

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."

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)."

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)."

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."

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."

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)."

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.

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."

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)."

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)."

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."

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)."

Secondary Outcomes

  • After-Scenario Questionnaire (ASQ): Post Interaction(Administered immediately after receiving randomized feedback/resources from TeACH System)
  • 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): Maintenance(Administered one week after interaction with TeACH System)

Study Sites (2)

Loading locations...

Similar Trials