Boston Medical Center has been approved for a $13.5 million award by the Patient-Centered Outcomes Research Institute (PCORI) to test the efficacy of two different methods of delivering cognitive behavioral therapy - face to face or online - to children with anxiety. This novel multi-site study will be conducted in both urban and semirural communities that serve primarily racial and ethnic minority children, and therapists connected with the pediatricians will deliver cognitive behavioral therapy face-to-face using the Cool Kids manual or facilitate use of the Cool Kids Online program.
Cognitive behavioral therapy (CBT) is a type of short-term therapy that is effective to treat anxiety in children, which is reported to affect nearly one in three. It involves patients learning about anxiety and then engaging in exposure practice, which means helping youth confront anxiety-provoking themes or situations in order to overcome fears. However, most children with anxiety do not receive treatment for many reasons, including lack of therapists, stigma, difficulty getting to appointments, and time commitment.
"Providing CBT treatments in community pediatrics practices could help many children, particularly those in lower-income and minority families that may not seek care elsewhere," said Lisa Fortuna, MD, medical director for child and adolescent psychiatry services at BMC and the study's principal investigator. "The study is the first to examine whether both in person and online CBT delivery in pediatric primary care could work well for these patients, as well as which format might be more effective for which patients."
With study sites in Boston, Miami, Seattle, and Baltimore, a cohort of more than 1,800 English and Spanish speaking children ages 3 to 17 with mild to moderate anxiety symptoms who see their pediatrician in participating clinics (a combination of community sites and larger hospital systems) will be invited to participate. Parents, patients, and providers will be actively engaged to help support the successful implementation of CBT and to ensure that the interventions include patient-centered outcomes and decision making.
The Cool Kids program, which was developed in Australia and has been studied in international research, focuses on identifying and challenging anxious thoughts, feelings, and behaviors, approaching avoided situations/events, systematic problem solving, assertiveness, and effective strategies for dealing with teasing and bullying. It is completed by parents for preschool-age children, by parents and their children together for those in grade school, and primarily by adolescents themselves in the 13 to 17 age range. Eligible youth presenting with clinically significant anxiety in pediatric primary care will be randomly assigned to receive 12 weeks of face-to face or online CBT and followed for up to two years.
Fortuna and her team will determine if the online format is as effective as face-to-face treatment for delivering CBT in the community and if certain characteristics about patients, families, therapists, and healthcare systems may influence each format's effectiveness, such as comfort with technology, internet access, distance to clinic, or other mental health problems.
The study was created with, and will be closely guided by, patient and parent input. Parents will also play a key role in evaluating the program; outcomes measured will consist of parent and patient reports of anxiety symptoms, functioning and family stress, and feedback on the intervention.
Fortuna's study was selected for funding through PCORI's Pragmatic Clinical Studies Initiative, an effort to produce results that are broadly applicable to a diverse range of patients and care situations and can be more quickly taken up in routine clinical practice. If the online delivery of CBT is found to be successful, it could offer a framework for implementation across the country.
Donna Pincus, PhD, of the Boston University Center for Anxiety and Related Disorders is the study's co-principal investigator, and Michelle Porche, EdD, of the newly merged Wheelock College of Education and Human Development at Boston University, is a co-investigator leading the qualitative component on family engagement and intervention dissemination on the project.
BMC's award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.