Engagement With DMH Technologies in Pediatric Primary Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Mental Health

Intervention / Treatment
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* Behavioral: TeACH System Resources


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group (TeACH System pyschoeducation and recommendations) and control group (evidence-based online educational materials)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TeACH System Resources<br>Patients who screen positive for anxiety will receive stakeholder-informed feedback and resources (i.e., psychoeducation and mental health recommendations). | Behavioral: TeACH System Resources<br>* 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.<br>|
| No Intervention: Evidence-based Resources<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Understanding | 1 item (Likert Scale); We will ask participants to rate their understanding of anxiety on a Likert scale (1-10; 10 being highest understanding) | Administered immediately after receiving randomized feedback/resources from TeACH System | 
| Anxiety Understanding Maintenance | 1 item (Likert Scale); We will ask participants to rate their understanding of anxiety on a Likert scale (1-10; 10 being highest understanding) | Administered one week after interaction with TeACH System | 
| Confidence to Act | 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 (1-10; 10 being highest confidence) | Administered immediately after receiving randomized feedback/resources from TeACH System | 
| 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 (1-10; 10 being highest confidence) | Administered one week after interaction with TeACH System | 
| Likelihood of using DMH for Anxiety | 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 (1-10; 10 being most likely) | Administered immediately after receiving randomized feedback/resources from TeACH System | 
| 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 (1-10; 10 being most likely) | Administered one week after interaction with TeACH System | 
| DMH use for Anxiety | 1 item (Y/N); We will ask participants to report if they have used digital mental health tools for their anxiety symptoms | Administered immediately after receiving randomized feedback/resources from TeACH System | 
| DMH use for Anxiety Maintenance, Change in DMH Use Following TeACH System Interaction | 1 item (Y/N); We will ask participants to report if they have used digital mental health tools for their anxiety symptoms | Administered one week after interaction with TeACH System | 
| System Usability Scale (SUS) | 10-item tool with five response options (1-Strongly Disagree to 5-Strongly Agree) for measuring usability | Administered once; immediately after receiving randomized feedback/resources | 
| Engagement | We will track the total number of diagnoses/recommendations reviewed and referred by providers during implementation phases. | Through study completion, an average of once per year. | 
| 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. | 
| Acceptability of Intervention Measure (AIM) | 4-item tool with five response options (1-Completely Disagree to 5-Completely Agree) to indicate implementation level of success for acceptability | Administered to primary care staff through study completion, an average of once per year. | 
| Intervention Appropriateness Measure (IAM) | 4-item tool with five response options (1-Completely Disagree to 5-Completely Agree) to indicate implementation level of success for appropriateness | Administered to primary care staff through study completion, an average of once per year. | 
| Feasibility of Intervention Measure (FIM) | 4-item tool with five response options (1-Completely Disagree to 5-Completely Agree) to indicate implementation level of success for feasibility | Administered to primary care staff through study completion, an average of once per year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kiddie-Computerized Adaptive Tests (K-CAT) | <8 minutes to complete; Uses item response theory to pull from a large question item bank to accurately diagnose 7 disorders. | Administered immediately after initiating use of the TeACH System; teen participants complete only once. | 
| COVID-19 Exposure and Family Impact Survey (CEFIS) | 25 Exposure and 12 Impact items; We will use the CEFIS to evaluate impacts of the COVID-19 pandemic on teens and their families. | Administered at the one-week follow-up survey for randomized participants. | 
| Self-Stigma of Seeking Help Scale (SSOSH) | 10-items; We will use the SSOSH to assess stigma for seeking mental health services. | Administered at the one-week follow-up survey for randomized participants. | 
| After-Scenario Questionnaire (ASQ) | 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 | 
| Program Sustainability Assessment Tool (PSAT) | 40 items; We will use the PSAT to assess primary care's ability to maintain the TeACH System and its benefits over time. | Administered to primary care staff through study completion, an average of once per year. | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Mental Health Technology, Digital Mental Health, Mental Health Disorders, Mental Health Wellness