Kids FACE FEARS Comparative Effectiveness Research

Completed · Not applicable

Conditions studied: Child Anxiety, Anxiety Disorders, Anxiety, Anxiety Symptoms, Anxiety, Mild to Moderate, Pediatric Anxiety Disorders

In brief

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.

Key facts

Study ID

NCT03707158

Run by

Boston Medical Center

People needed

305

Starts

2019-10-08

Expected to finish

2024-06-06

Last updated by the study team

2025-03-27

Who can join

Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children age 7-18 years at the time of screening
• Child has elevated anxiety as indicated by a T-score above 55 (greater than 0.5 SD (Standard Deviation) above the mean) on the PROMIS Item Bank v2.0 - Anxiety - Short Form 8a (child self-report or parent proxy report) in English or Spanish at the time of screening
• Child and caregiver(s) are fluent in English or Spanish
• Child's parent or legal guardian is age 16 or older
• If child taking SSRI/Pharmacotherapy for anxiety, must be on stable dose for greater than or equal to 8 weeks from the time of screening (self-reported, must be reported by parent if under the age of 18)
• Receiving care at sites participating in the study

You may not qualify if…

• Severity requiring higher level of care, as indicated by any of the following: (a) suicidal thoughts or behaviors (STP) with an active plan; (b) STB(s) requiring higher level of care in the past 6 months; (c) anxiety-related absence > 50% of school days over the past month (if summer, the last month of school enrolled); (d) substance use that required emergency services or inpatient/partial hospitalization within past 3 months; or (e) clinician-determination that child requires higher level of care.
• History of diagnosed autism spectrum disorder with severe challenges and needs for support (e.g., complete absence of verbal communication unrelated to anxiety), or intellectual disability with severe challenges or needs for support.
• Currently engaged in CBT or planning to continue a non-study psychotherapy for anxiety during the time of the study (self-reported, must be reported by parent if under the age of 18)
• Treatment participants not fluent in English or Spanish
• Child is ward of the state

Where it is running

• Nicklaus Children's Hospital — Miami, Florida, United States
• Florida International University — Miami, Florida, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• South Boston Community Health Center — Boston, Massachusetts, United States
• Harborview Medical Center — Seattle, Washington, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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