CompletedNot Applicable

Kids FACE FEARS Comparative Effectiveness Research

United States305 participantsStarted 2019-10-08

Plain-language 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.

Who can participate

Age range7 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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
✕. 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.

What they're measuring

Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)

Timeframe: Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)

Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)

Timeframe: Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)

Child Anxiety Life Interference Scale (CALIS), Caregiver Report

Timeframe: Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)

Child Anxiety Life Interference Scale (CALIS), Youth Self-Report

Timeframe: Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)

Trial details

NCT IDNCT03707158

SponsorBoston Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-09

Results submitted2025-01-23

View on ClinicalTrials.gov More Child Anxiety trials

Plain-language summary

Who can participate

Age range7 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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
✕. 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.