Kids FACE FEARS Comparative Effectiveness Research

NCT03707158 | Completed Results DMC

• 2 other identifiers: H-378626005686
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Child Anxiety; Anxiety Disorders; Anxiety; Anxiety Symptoms; Anxiety, Mild to Moderate; Pediatric Anxiety Disorders

Keywords

Cognitive Behavioral Therapy (CBT); Online CBT; Telehealth; Anxiety; Child; Therapist-Led CBT; Pediatric Anxiety; Internet-Delivered CBT; iCBT; Telemental Health; Adolescent; Teen; Youth anxiety; Comparative Effectiveness

Outcome Measures

Primary Outcomes (4)

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

  This caregiver-report anxiety questionnaire is a publicly available measure that assesses youth fear, anxiety, misery, hyper-arousal, and somatic symptoms related to arousal. It also assesses behavioral fear avoidance. The form is available in English and Spanish and has excellent reliability and validity. The form includes 8 items and uses a scale of 1-5 (1=Never, 2=Almost never, 3= Sometimes, 4=Often, 5=Almost always). The raw score is the sum of the points for each response (range: 8-40), with higher scores represents higher levels of anxiety. Raw scores are converted to T-scores (range: 33.5-88.3), with higher T-scores representing higher levels of anxiety. T-scores of 50 reflect the population mean with a standard deviation of 10. Scores of 55 indicated elevated anxiety and \>=60 reflecting clinical levels of anxiety. T scores are reported here and were subjected to analyses.

  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)

  This youth self-report anxiety questionnaire is a publicly available measure that assesses youth fear, anxiety, misery, hyper-arousal, and somatic symptoms related to arousal. It also assesses behavioral fear avoidance. The form is available in English and Spanish and has excellent reliability and validity. The form includes 8 items and uses a scale of 1-5 (1=Never, 2=Almost never, 3= Sometimes, 4=Often, 5=Almost always). The raw score is the sum of the points for each response (range: 8-40), with higher scores represents higher levels of anxiety. Raw scores are converted to T-scores (range: 33.5-88.3), with higher T-scores representing higher levels of anxiety. T-scores of 50 reflect the population mean with a standard deviation of 10. Scores of 55 indicated elevated anxiety and \>=60 reflecting clinical levels of anxiety. T scores are reported here and were subjected to analyses.

  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

  The Child Anxiety Life Interference Scale (CALIS) parent-report is a measure of caregiver perceptions of life interference and impairment associated with child anxiety. The CALIS has demonstrated strong psychometric properties, and assesses impairments in family, peer, academic, and extracurricular life domains. The CALIS parent-report 16 items administered to caregivers. All items, which relate to common activities (e.g. "being with friends outside of school" or "your career choice"), are rated on a five-point Likert scale (0 = not at all, 4 = a great deal), with higher scores indicating higher anxiety life interference. Scores range from 0-64.

  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

  The Child Anxiety Life Interference Scale (CALIS) youth-report is a measure of youth self-reports of life interference and impairment associated with child anxiety. The CALIS has demonstrated strong psychometric properties, and assesses impairments in family, peer, academic, and extracurricular life domains. The CALIS youth self-report 9 items. All items, which relate to common activities (e.g. "being with friends outside of school" or "your career choice"), are rated on a five-point Likert scale (0 = not at all, 4 = a great deal), with higher scores indicating higher anxiety life interference. Scores range from 0-36.

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

Secondary Outcomes (12)

• Caregiver Treatment Satisfaction (Continuously Scored)

  Posttreatment (on average, 19 weeks)

• Caregiver Treatment Dissatisfaction (% of "Dissatisfied" Caregivers, Based on Dichotomous Coding of Dissatisfaction)

  Posttreatment (on average, 19 weeks)

• Youth Treatment Satisfaction (Continuously Scored)

  Posttreatment (on average, 19 weeks)

• Youth Treatment Dissatisfaction (% of "Dissatisfied" Youth, Based on Dichotomous Coding of Dissatisfaction)

  Posttreatment (on average, 19 weeks)

• Caregiver-Perceived Effectiveness

  Posttreatment (on average, 19 weeks)

Study Arms (2)

Guided Online CBT (with minimal therapist involvement)

ACTIVE COMPARATOR

The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, self-paced, self-administered online digital CBT anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was assigned from the online suite of online Cool Kids interventions (i.e., Cool Kids Online for 7-12 year olds; Chilled Out for 13+ year olds)

Behavioral: Guided Online CBT

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

ACTIVE COMPARATOR

The Cool Kids suite of therapist-led CBT-based programs for youth anxiety is a well-supported anxiety management intervention, delivered by a therapist across weekly sessions. The therapist-led cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. Depending on the age of the child, one of two developmentally tailored programs was implemented from the suite of therapist-led Cool Kids interventions (i.e., Cool Kids for 7-12 year olds; Chilled for 13-18 year olds). For the present study, Therapist-led CBT could be implemented via telehealth or in-person (i.e., office-based), or as a hybrid format of both telehealth and office-based care. For each therapist-led CBT case, the specific format of care (i.e., telehealth, office-based, or hybrid) was determined via patient/family preferences, collaborative decision-making, hospital policies, and/or COVID-related mandates.

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

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.

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

Guided Online CBT BEHAVIORAL

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.

Guided Online CBT (with minimal therapist involvement)

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not 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
• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Massachusetts General Hospital: collaborator
• South Boston Community Health Center: collaborator
• Johns Hopkins University: collaborator
• Nicklaus Children's Hospital f/k/a Miami Children's Hospital: collaborator
• Boston University: collaborator
• Florida International University: collaborator
• University of Washington: collaborator
• Seattle Children's Hospital: collaborator

Study Sites (8)

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Florida International University

Miami, Florida, 33199, United States

Location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

South Boston Community Health Center

Boston, Massachusetts, 02127, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Donna Pincus
• Organization: Boston University

dpincus@bu.edu

(617) 353-9610

Study Officials

• Jonathan S Comer, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

• Donna B Pincus, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators (IEs) are masked to treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic Comparative Effectiveness RCT; Type I Hybrid Effectiveness and Implementation Study

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 16, 2018
• Study Start: October 8, 2019
• Primary Completion: April 9, 2023
• Study Completion: June 6, 2024
• Last Updated: March 27, 2025
• Results First Posted: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Will post by Dec 31, 2025. Will be available for at least 7 years (until Dec 30, 2032).
• Access Criteria: Will be posted for public access and use on the Patient-Centered Outcomes Data Repository.

Locations

US (8)