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

Not Applicable
Recruiting
Conditions
Mental Health
Interventions
Behavioral: TeACH System Resources
Registration Number
NCT05466929
Lead Sponsor
Rush University Medical Center
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. 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
300
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
TeACH System ResourcesTeACH System ResourcesPatients who screen positive for anxiety will receive stakeholder-informed feedback and resources (i.e., psychoeducation and mental health recommendations).
Primary Outcome Measures
NameTimeMethod
Anxiety Understanding: BaselineAdministered 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: BaselineAdministered 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 InteractionAdministered 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 InteractionAdministered 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 InteractionAdministered 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: MaintenanceAdministered 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: BaselineAdministered 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)."

EnrollmentThrough 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 InteractionAdministered 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: MaintenanceAdministered 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: BaselineAdministered 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: MaintenanceAdministered 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 InteractionAdministered 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 Outcome Measures
NameTimeMethod
After-Scenario Questionnaire (ASQ): Post InteractionAdministered 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

Kiddie-Computerized Adaptive Tests (K-CAT) Anxiety ModuleAdministered 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.

After-Scenario Questionnaire (ASQ): MaintenanceAdministered one week after interaction with TeACH System

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

Trial Locations

Locations (2)

University of Illinois at Chicago

🇺🇸

Chicago, Illinois, United States

Rush University Medical Center

🇺🇸

Chicago, Illinois, United States

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