Background and Significance: Cognitive behavioral therapy (CBT) is a type of therapy that can be effective to treat anxiety in children. It is a short-term therapy that involves 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 the time commitment. Online delivery of CBT leads to symptom improvement in research settings and could make CBT more accessible to more families. Providing these treatments in community pediatric health settings could help even more children, particularly among lower-income and minority families that may not seek care elsewhere. Research has yet to compare the effectiveness on a large scale of in-person versus online delivery of CBT for anxious youth identified in diverse pediatric health settings, nor has research directly compared whether these two supported youth anxiety treatment formats may be differentially indicated for particular patient subgroups or scenarios.
Study Aims: Kids FACE FEARS (Face-to-face And Computer-Enhanced Formats Effectiveness study for Anxiety and Related Symptoms) is comparing two different methods of CBT delivery —therapist-led, face-to-face care versus self-administered, online intervention—in the treatment of youth anxiety identified in diverse pediatric health settings that primarily serve racial/ethnic minority youth. To optimize the relevance, patient-centeredness, and generalizability of this effort, and to maximize the potential for meaningful and sustainable impact, parents, patients, providers, and other key stakeholders are actively engaged in all aspects of the project. Kids FACE FEARS aims to directly compare the effectiveness of face-to-face versus online treatment for youth anxiety identified in pediatric health settings, evaluate both acute and longer-term outcomes across a two-year follow-up period, and test whether the relative effectiveness of each of these two treatment formats varies for different patient subpopulations or circumstances.
Study Description: English- and Spanish-speaking children ages 3 to 18 who are identified in pediatric health settings with mild-to-moderate anxiety symptoms are invited to participate. Patients are randomly assigned to receive either face-to-face or online treatment. The treatments delivered in Kids FACE FEARS are from the Cool Kids suite of face-to-face and online programs for youth anxiety. Treatment is delivered by frontline providers in pediatric health settings who, as part of this project, are receiving remote consultation from experts in CBT for youth anxiety. Families assigned to receive online CBT complete self-administered, web-delivered treatment modules, in addition to participating in brief biweekly phone calls from a therapist. Both treatment formats are being offered in English and in Spanish. For each patient, outcomes are being assessed across a two-year follow-up period. Study findings will help compare outcomes between these two supported treatment formats, and whether certain patient, family, therapist, and healthcare system factors may differentially influence the effectiveness of each of these CBT formats (e.g., comfort with technology, internet access, distance to clinic, other mental health problems). Outcome measures include parent and patient reports of anxiety symptoms, impact of anxiety on functioning, family stress, treatment satisfaction, and feedback on the intervention. Findings will be disseminated immediately and widely to transform best practices for the treatment of youth anxiety in the community.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.