N/A
N=305
Kids FACE FEARS Comparative Effectiveness Research
Child Anxiety · Anxiety Disorders · Anxiety · Anxiety Symptoms · Anxiety, Mild to Moderate
Bottom Line
View on ClinicalTrials.gov: NCT03707158 ↗Enrolled (actual)
305
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report) — 65.7; 66.0; 59.2; 59.1 T-Score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Therapist-Led CBT (telehealth, office-based, or hybrid) (Behavioral); Guided Online CBT (Behavioral)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report) |
65.7; 66.0; 59.2; 59.1; 57.9; 57.7 | — |
| PRIMARY Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report) |
61.4; 61.2; 55.6; 56.4; 54.7; 54.4 | — |
| PRIMARY Child Anxiety Life Interference Scale (CALIS), Caregiver Report |
26.3; 26.8; 20.2; 20.5; 18.9; 19.3 | — |
| PRIMARY Child Anxiety Life Interference Scale (CALIS), Youth Self-Report |
13.1; 13.4; 10.6; 11.1; 10.6; 10.1 | — |
| SECONDARY Caregiver Treatment Satisfaction (Continuously Scored) |
2.2; 2.7 | — |
| SECONDARY Caregiver Treatment Dissatisfaction (% of "Dissatisfied" Caregivers, Based on Dichotomous Coding of Dissatisfaction) |
23.9; 6.8 | — |
| SECONDARY Youth Treatment Satisfaction (Continuously Scored) |
2.1; 2.4 | — |
| SECONDARY Youth Treatment Dissatisfaction (% of "Dissatisfied" Youth, Based on Dichotomous Coding of Dissatisfaction) |
33.3; 19.9 | — |
| SECONDARY Caregiver-Perceived Effectiveness |
2.9; 4.2 | — |
| SECONDARY Rate of Treatment Responders (% of Children Whose Posttreatment PARS Score Was at Least 35% Less Than Their Baseline PARS Score) |
48.7; 55.4 | — |
| SECONDARY Caregiver Homework Engagement (% of Weeks Caregiver Completed Assigned Homework) |
53.1; 70.7 | — |
| SECONDARY Youth Homework Engagement (% of Weeks Youth Completed Assigned Homework) |
50.8; 61.9 | — |
| SECONDARY Treatment Completion (% of Children Who Completed Their Treatment Program) |
53.2; 46.3 | — |
| SECONDARY Treatment Comprehension Difficulties (Caregiver Report) |
1.67; 1.01 | — |
| SECONDARY Difficulty Making Time for Treatment (Caregiver Report) |
3.17; 2.14 | — |
| SECONDARY Treatment Discomfort (Caregiver Report) |
2.81; 2.86 | — |
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.
Eligibility Criteria
To maximize generalizability, inclusion criteria were wider and exclusion criteria were minimal compared to majority of previous RCTs of youth anxiety treatment
Inclusion 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03707158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.