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

Mental Health Clinical Trial

— TeACH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05466929
• Other study ID #: K08MH125069
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health

Intervention

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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	Gender, race/ethnicity, age, sexual orientation, education, employment, household income, and lifetime psychiatric diagnoses/treatment.	Through study completion, an average of once per year.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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