CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 305 enrolled
Drug / intervention
Therapist-Led CBT (telehealth, office-based, or hybrid) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03707158
NCT03707158N/ACompleted

Kids Formats of Anxiety Care Effectiveness Study For Extending the Acceptability and Reach of Services (Kids FACE FEARS)

Boston Medical Center·interventional·Posted Oct 16, 2018·Updated Mar 27, 2025

In Brief

A clinical study evaluating Therapist-Led CBT (telehealth, office-based, or hybrid) and Guided Online CBT for Child Anxiety and 5 related conditions. Completed, enrolled 305 participants across 8 sites.

Detailed Summary

The Kids FACE FEARS (Kids Formats of Anxiety Care Effectiveness study For Extending the Acceptability and Reach of Services) is a large-scale, streamlined, pragmatic Randomized Controlled Trial (RCT) evaluating Therapist-Led CBT (telehealth, office-based, or hybrid) vs. Guided Online Cognitive-Behavioral Therapy (CBT) for the treatment of elevated child and adolescent anxiety. Families will be recruited from pediatric health centers serving primarily racial/ethnic minority youth in urban, suburban, and semi-rural regions. Services will be offered in English and Spanish. Patient-centered outcomes will be evaluated across a one-year follow-up period. To compare the effectiveness of the two treatment comparators, investigators will analyze the reports of caregivers, youth, and therapists, as well as independent evaluators who are not informed of each child's treatment assignment. Primary outcomes will focus on family-rated anxiety severity and impairment, treatment responder and remission status rated by independent evaluators, family-perceived effectiveness, and treatment satisfaction. Secondary analyses will examine additional outcomes, predictors of varied outcomes across different subgroups of youth, and facilitators and barriers to treatment implementation. Caregivers, patients, providers, and other key stakeholders will be actively engaged throughout all aspects of the research.

Study Details

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 16, 2018
Enrollment StartOct 8, 2019
Primary CompletionApr 9, 2023
Study CompletionJun 6, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.7 years ago

Interventions

Therapist-Led CBT (telehealth, office-based, or hybrid)behavioral

Participants receiving therapist-led CBT will participate in therapist-led (telehealth or office-based) CBT treatment for up to 20 weeks. Weekly therapist-led treatment sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.

Guided Online CBTbehavioral

Participants receiving guided online CBT will complete an online, self-paced, standardized and digitalized CBT program for up to 20 weeks with 8 modules, with adjunctive therapist phone support for supportive accountability. The self-administered treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.