Clinical trial NCT05466929: Engagement With Digital Mental Health (DMH) Technologies in Pediatric Primary Care
Official title: Supporting Mental Health in Underserved Youth: Engagement With Digital Mental Health Technologies in Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Keywords: Digital Mental Health Technology
Digital Mental Health
Mental Health Disorders
Mental Health Wellness
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
First posted: 2022-07-20
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group (TeACH System psychoeducation and recommendations) and control group (evidence-based online educational materials)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Anxiety Understanding: Baseline
timeFrame: Administered following assent (in case of participant attrition through the interaction)
measure: Anxiety Understanding: Post Interaction
timeFrame: Administered immediately after receiving randomized feedback/resources
measure: Anxiety Understanding: Maintenance
timeFrame: Administered one week after interaction with TeACH System
measure: Confidence to Act: Baseline
timeFrame: Administered following assent (in case of participant attrition through the interaction)
measure: Confidence to Act: Post Interaction
timeFrame: Administered immediately after receiving randomized feedback/resources
measure: Confidence to Act: Maintenance
timeFrame: Administered one week after interaction with TeACH System
measure: Likelihood of using DMH for Anxiety: Baseline
timeFrame: Administered following assent (in case of participant attrition through the interaction)
measure: Likelihood of using DMH for Anxiety: Post Interaction
timeFrame: Administered immediately after receiving randomized feedback/resources
measure: Likelihood of using DMH for Anxiety: Maintenance
timeFrame: Administered one week after interaction with TeACH System
measure: DMH use for Anxiety: Baseline
timeFrame: Administered following assent (in case of participant attrition through the interaction)
measure: DMH use for Anxiety: Post Interaction
timeFrame: Administered immediately after receiving randomized feedback/resources
measure: DMH use for Anxiety: Maintenance, Change in DMH Use Following TeACH System Interaction
timeFrame: Administered one week after interaction with TeACH System
measure: Enrollment
timeFrame: Through study completion, an average of once per year.
Secondary outcomes:
measure: Kiddie-Computerized Adaptive Tests (K-CAT) Anxiety Module
timeFrame: Administered immediately after initiating use of the TeACH System; teen participants complete only once.
measure: After-Scenario Questionnaire (ASQ): Post Interaction
timeFrame: Administered immediately after receiving randomized feedback/resources from TeACH System
measure: After-Scenario Questionnaire (ASQ): Maintenance
timeFrame: Administered one week after interaction with TeACH System
Other outcomes:
measure: Demographics
timeFrame: Administered immediately after initiating use of the TeACH System; teen participants complete only once.
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: