Implementing a Pragmatic, Multi-Site Effectiveness Trial Examining Pediatric Anxiety Treatments During COVID-19: Challenges and Lessons

HANIYA SALEEM SYEDA, MPH
Boston Medical Center

Anxiety disorders are the most prevalent mental health problems affecting children, yet very few children with anxiety receive treatment. Kids FACE FEARS (Face-to-face and Computer-Enhanced Formats Effectiveness study for Anxiety and Related Symptoms) is a hybrid effectiveness-implementation randomized trial comparing therapist-led cognitive-behavioral therapy (CBT) versus self-administered online CBT for anxious youth in pediatric health settings. Screening for anxiety and implementing CBT directly within pediatric health settings, and using online formats, can overcome many traditional barriers to care. Recruitment began in 5 months before the COVID-19 pandemic began, and the study is still underway. This presentation describes the challenges of continuing implementation of a pragmatic clinical trial during a pandemic.

Eligible youth (ages 7-18 years; N=300) are being identified via universal screening and/or anxiety referral in large pediatric health care networks serving primarily racial/ethnic minority children across four regions: Boston, Miami, Baltimore, and Seattle. To maximize generalizability, English and Spanish speaking families are eligible.

To gather information on impacts of the pandemic on implementation of the trial, regional investigators and coordinators provided weekly updates to PIs on: 1) local COVID-related IRB research regulations and changes, 2) COVID-related changes in policies and clinical care at recruitment sites, 3) changes in state legislation related to insurance coverage for telehealth delivery of behavioral healthcare, and 4) barriers to recruitment. Changes to the study design and COVID-19 related challenges were also discussed with the Scientific Steering Committee, as well as with a Parent and Family Advisory Board for feedback.

Adaptions were made to the study design in response to needs identified by investigators, committee members, stakeholders, and the funder which included: 1) allowing therapist-led study arm to allow for inclusion of either telehealth and office-based CBT; 2) including a hybrid model of office-based and telehealth for therapist-led delivery to account for patient preference; 3) flexibility to use secure videoconferencing software for study visits based on participant preference; and 4) the need for assessment questions regarding exposure to COVID-19. Key factors that impacted regional sites’ recruitment success included: 1) state regulation of clinical care settings; 2) lack of IRB restrictions on recruitment and study activities; and 3) clinic’s previous experience with telehealth systems.

The COVID-19 pandemic created unique challenges in continued implementation of a multi-site national pragmatic trial. To improve implementation and foster more patient-centered research, it was crucial to collaborate with all study team members and stakeholders to identify necessary adjustments to the study design.