Digital Mental Health Screening, Feedback, and Referral System for Teens With Socially Complex Needs: Protocol for a Randomized Controlled Trial Integrating the Teen Assess, Check, and Heal System into Pediatric Primary Care
Authors: Stiles-Shields Colleen , Bobadilla Gabriella , Reyes Karen , Gustafson Erika L , Lowther Matthew , Smith Dale L , Frisbie Charles , Antognini Camilla , Dyer Grace , MacCarthy Rae , Martinengo Nicolò , Morris Guy , Touranachun Alissa , Wilkens Kimberlee M , Julion Wrenetha A , Karnik Niranjan S 
Published: December 2024

Background
Teens with socially complex needs—those who face multiple and potentially overlapping adversities—are disproportionately affected by several barriers to mental health screening and treatment. Pediatric primary care (PPC) is a typically low-stigmatized setting for teens that is visited at least annually. As such, implementing digital mental health tools (DMH), as low-intensity treatments in PPCs may increase the reach of such tools for teens with socially complex needs.

Objective
This study aimed to evaluate the Teen Assess, Check, and Heal (TeACH) System in comparison to a control condition while integrated into PPCs at 2 Medical Centers serving teen patients in Chicago, Illinois. Through collaboration with key players throughout the design and implementation planning phases, the TeACH System is hypothesized to increase teen patient self-reported engagement with DMH and address specific individual-level barriers to mental health care, compared with a digital psychoeducation control condition.

Methods
Eligible participants will be recruited through PPC clinics housed within the University of Illinois Chicago (UIC) and Rush University Medical Center (RUSH). Recruitment involves invitations from research staff members and primary care clinicians and staff members, as well as posting flyers with QR codes at the specified clinics. All participants complete a brief demographic survey, baseline survey, and Kiddie-Computerized Adaptive Tests Anxiety Module. Participants are randomized to receive either the control condition (digital evidence-based workbook) or the intervention (TeACH System Feedback and Resources). All randomized participants will then be invited to complete an immediate and 1-week follow-up survey. The primary outcomes assess changes in engagement with DMH (ie, likelihood to use DMH for anxiety and actual DMH use) and individual-level barriers to mental health care (ie, symptom understanding and confidence to act). Descriptive analyses will be conducted to characterize the sample and usability ratings of the TeACH System. Linear or generalized linear mixed effects regression models will examine differences in primary outcomes over time.

Results
Recruitment began in July 2024 and data collection is expected to be completed by August 2025. To date, 122 teens have assented to complete study activities, 80 have been randomized (an additional 24 teens have had subthreshold anxiety symptoms and were therefore not randomized), and 42 teens have completed the 1-week follow-up assessment.

Conclusions
This study will provide preliminary feasibility data that may inform how the TeACH System and other DMH low-intensity treatments might better engage and support teens with socially complex needs.

Trial Registration
ClinicalTrials.gov NCT05466929; https://clinicaltrials.gov/study/NCT05466929

International Registered Report Identifier (IRRID)
DERR1-10.2196/65245