ABSTRACT
Background: Rising rates of adolescent depression in the wake of COVID-19 and a youth mental health crisis highlight the urgent need for accessible mental healthcare and prevention within primary care. Digital mental health interventions (DMHIs) may increase access for underserved populations. However, these interventions are not well studied in adolescents, nor healthcare settings. The purpose of this study was to identify barriers and facilitators to screening and recruitment activities for PATH 2 Purpose (P2P): Primary Care and Community-Based Prevention of Mental Disorders in Adolescents, a multi-site adolescent depression prevention trial comparing two digital prevention programs within four diverse health systems in two U.S. states. Method: This qualitative study is a component of a larger Hybrid Type I trial. We conducted semi-structured key informant interviews with clinical and non-clinical implementers involved with screening and recruitment for the P2P trial. Informed by the Consolidated Framework for Implementation Research (CFIR), interviews were conducted at the midpoint of the trial to identify barriers, facilitators, and needed adaptations, and to gather information on determinants that may affect future implementation. Findings: Respondents perceived the P2P trial as valuable, well aligned with the mission of their health systems. However, several barriers were identified, many of which stemmed from influences outside of the healthcare settings. Universal and site-specific outer setting influences (COVID-19 pandemic, youth mental health crisis, local community conditions) interacted with Inner Setting and Innovation domains to create numerous challenges to the implementation of screening and recruitment. Conclusion: Our findings emphasize the need for ongoing, comprehensive assessment of dynamic inner and outer setting contexts prior to and during implementation of clinical trials, as well as flexibility for adaptation to unique clinical contexts. The CFIR is useful for assessing determinants during times of rapid inner and outer setting change, such as those brought on by the COVID-19 pandemic, youth mental health crisis, and the corresponding exacerbation of resource strain within healthcare settings. Clinical trial registration: PATH 2 Purpose: Primary Care and Community-Based Prevention of Mental Disorders in Adolescents https://www.clinicaltrials.gov/study/NCT04290754.
Adolescent mental health problems such as depression, anxiety, and suicidal behavior are prevalent, and have been increasing in the wake of the COVID-19 pandemic. In 2021, the Surgeon General declared a "youth mental health crisis," and the American Academy of Pediatrics issued a joint statement declaring a national youth mental health emergency. Accessible, affordable, evidence-based interventions are needed to prevent the development of depressive symptoms into major depressive disorder. The integration of digital mental health interventions (DMHIs) into primary care may reduce access barriers. Primary care clinical settings are well suited to identify individuals at-risk for developing depression, and facilitate preventive treatment planning. While preventive DMHIs for adolescents exist, more evidence is needed on their effectiveness, and how to best integrate them into healthcare. Our study team interviewed primary care-based staff, administrators, and clinical providers involved with implementing screening and recruitment activities for the P2P trial, a randomized controlled trial comparing the effectiveness of two digital depression prevention programs. Respondents shared experiences with trial recruitment in their settings, including perceived challenges. Our findings suggest that multiple factors influenced recruitment, including influences situated outside of the clinical settings, such as the COVID-19 pandemic and worsening adolescent mental health. These influences interacted with factors affecting recruitment inside of health clinics, such as demands on staff and provider time, and perceived importance of prevention programming versus other initiatives. Identifying these influencing factors during the trial helps to inform considerations for planning future integration of similar programs into primary care settings.
ABSTRACT
The majority of mental, emotional, and behavioral (MEB) disorders have an initial onset before age 24, with 20% annual incidence, and with major depressive disorder (MDD) being the most common MEB. Health systems may be able to reduce costs by transitioning from the current treatment-focused model for MDD to a prevention model. However, evidence is needed for (1) the comparative effectiveness of a "scalable intervention" and (2) an implementation model for such a scalable intervention in the primary care setting. This paper describes a comparative effectiveness trial evaluating the efficacy of two evidence-based cognitive-behavioral prevention (CBP) programs: Teens Achieving Mastery over Stress (TEAMS), the "gold standard," group therapy model, and Competent Adulthood Transition with Cognitive Behavioral, Humanistic and Interpersonal Training (CATCH-IT), a scalable, self-directed, technology-based model. Eligible adolescents, age 13-19, are offered one of these two depression prevention programs across five health systems (30 clinics) in urban and suburban Chicago, IL, rural Western IL, and Louisville, KY. We are comprehensively evaluating patient-centered outcomes and stakeholder-valued moderators of effect versus baseline at two, six, 12, and 18-month assessment points. Using a hybrid clinical trial design that simultaneously examines the implementation process, the study is also assessing adolescents', parents', and providers' experiences (e.g., efficacy, time commitment, cultural acceptability) within each intervention approach.
