Kids FACE FEARS Comparative Effectiveness Research

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

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 Overview

• Status: Completed
• Conditions: Anxiety Disorders; Anxiety; Anxiety Symptoms; Child Anxiety; Anxiety, Mild to Moderate; Pediatric Anxiety Disorders
• Intervention / Treatment: Behavioral: Guided Online CBT; Behavioral: Therapist-Led CBT (telehealth, office-based, or hybrid)

Detailed Description

Clinical anxiety is among the most common and impairing psychiatric conditions affecting children and adolescents. Cognitive Behavioral Therapy (CBT) is an effective psychological treatment for youth anxiety, with roughly 60% of youth showing considerable clinical response and global improvements in functioning. Regrettably, despite the existence of well-supported treatments, most youth with anxiety disorders do not receive any form of treatment, especially in resource poor settings.

To extend the reach of CBT, research has provided initial support for several modernized modes of CBT delivery that differentially draw on technology to support varying levels of therapist involvement. For example, telehealth and hybrid options (i.e., mix of telehealth and office-based care) leverage synchronous telecommunications (typically videoconferencing) for the remote provision of live and interactive therapist-led care. Telehealth has been increasingly studied with success as a means to overcome several logistical challenges to traditional brick-and-mortar CBT for youth anxiety and stigma about attending a mental health facility. After years of initial research,m telehealth and hybrid formats became a dominant mode of outpatient mental health care, and in post-pandemic times these formats still play a prominent role (albeit understudied) role in youth mental health care.

Whereas telehealth and hybrid formats offer opportunities to extend the reach of therapist-led CBT, guided online CBT (i.e., self-paced and relatively automated care with minimal therapist involvement) offers a computerized treatment delivery format that reduces therapist demands and person-power needs relative to therapist-led care. For some, guided online CBT may be a more accessible, acceptable, and even effective format, although attrition can be high in self-paced care.

Despite great promise in the use of technology-based strategies for expanding the reach of CBT for pediatric anxiety, much remains to be learned about how such alternative CBT formats perform in typical care settings, what factors may facilitate versus challenge successful implementation and engagement in usual care settings, and whether specific subpopulations of anxious youth may differentially benefit from these options. As with the majority of controlled evidence supporting therapist-led CBT for youth anxiety, most support for telehealth and hybrid CBT has come from trials conducted in tightly controlled contexts and anxiety specialty clinics with highly selected samples and research therapists. Such work cannot speak to the effectiveness of telehealth effectiveness under typical care circumstances. Many of these studies have also been relatively small and underpowered to examine predictors of differential telehealth response. With regard to guided online CBT for pediatric anxiety, research to date has been conducted with predominantly non-Hispanic White and English-speaking samples, and most of the trials have been implemented in anxiety-specialty clinics and/or research settings. Evaluating the effectiveness of guided online CBT in diverse populations under usual care conditions is critical for understanding the extent to which this format can truly expand the accessibility and acceptability of care and reach underserved populations. Furthermore, clinical trials of guided online CBT for anxiety have not included a therapist-led treatment comparison, rendering it hard to make informed comparisons across treatment formats and precluding an understanding of which CBT formats for youth anxiety work best for whom.

The pediatric health care setting offers an optimal public health venue for youth anxiety management, yet there is a critical lack of behavioral health specialty care providers in these settings who are trained in providing mental health treatment, and a lack of information on the optimal methods of treating anxiety in pediatric settings. Accordingly, technology-based treatment options may be a particularly welcome format in pediatric usual care settings..

The Kids FACE FEARS study design entails a large-scale, streamlined, pragmatic, randomized controlled trial (RCT), in which eligible youth with elevated anxiety identified in pediatric health care settings will be randomly assigned to therapist-led CBT (delivered via telehealth, hybrid, or office-based) versus guided online CBT intervention for youth anxiety and monitored for up to one year out. Outcomes for each participant will be monitored across four major assessment points, corresponding to baseline, mid-treatment, post-treatment, and 1 year follow-up. Acute and longer-term outcomes associated with therapist-led versus guided online CBT will be evaluated over a 1-year follow-up period. We will use the well-established Cool Kids suite of therapist-led and online anxiety CBT protocols within pediatric health care networks serving primarily racial-ethnic minority children in both urban and rural settings across four regions of the US: the Northeast, the Mid-Atlantic, the Southeast, and the Pacific Northwest. Natural providers (i.e., not research therapists or anxiety specialists) in these pediatric usual care settings will provide all services. All participants will be identified and referred for enrollment from pediatric health settings. All care and study materials will be provided in English and Spanish.

This study addresses three critical yet unanswered questions related to improving the delivery of modernized CBT formats and treatment outcomes for anxiety in pediatric usual care settings. Answering the following question offers the potential to meaningfully improve the quality of the evidence available to help children, families, and organizational stakeholders make informed, patient-centered decisions regarding clinical practice and implementation strategies for the treatment of youth anxiety:

1. Comparative Effectiveness: What is the comparative effectiveness of therapist-led (telehelath, hybrid or office-based) versus guided online formats of CBT to treat youth anxiety presenting to pediatric usual care settings?
2. Heterogeneity of Treatment Effects: Are there key factors that predict or moderate differential treatment engagement or response? Such factors, in turn, can inform treatment personalization for various patient subgroups, and ultimately more patient-centered care for pediatric anxiety.
3. What are the barriers and facilitators to delivering these treatment comparators in pediatric usual care settings and for the diverse patient populations served?

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33155
      • Nicklaus Children's Hospital
    • Miami, Florida, United States, 33199
      • Florida International University
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Boston, Massachusetts, United States, 02127
      • South Boston Community Health Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

To maximize generalizability, inclusion criteria were wider and exclusion criteria were minimal compared to majority of previous RCTs of youth anxiety treatment

Inclusion Criteria

1. Children age 7-18 years at the time of screening
2. 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
3. Child and caregiver(s) are fluent in English or Spanish
4. Child's parent or legal guardian is age 16 or older
5. 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)
6. Receiving care at sites participating in the study

Exclusion Criteria

1. 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.
2. 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.
3. 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)
4. Treatment participants not fluent in English or Spanish
5. Child is ward of the state

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Guided Online CBT (with minimal therapist involvement); 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; 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.
Active Comparator: Therapist-Led CBT (telehealth, office-based, or hybrid delivered); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Treatment Satisfaction (Continuously Scored)	To assess Caregivers Treatment Satisfaction, caregivers were administered a Satisfaction Scale that had them rate three items along 0-3 rating scales at at posttreatment: "Overall, how satisfied [have you been/were you] with the services that your family received?" [0=quite dissatisfied; 3=very satisfied]; "Would you recommend this program to a friend if they had a child with anxiety?" [0=no, definitely not; 3=yes, definitely]; and "How pleased [have you been/were you] with how this program has helped your child with anxiety" [0=quite displeased; 3=very pleased]. These three items were averaged for each informant to generate a Caregiver Total Satisfaction Score (range: 0-3, higher scores reflect greater satisfaction).	Posttreatment (on average, 19 weeks)
Caregiver Treatment Dissatisfaction (% of "Dissatisfied" Caregivers, Based on Dichotomous Coding of Dissatisfaction)	At posttreatment caregivers were asked to rate three items developed for the present trial along 0-3 rating scales: "Overall, how satisfied were you with the services that your family received?" [0=quite dissatisfied; 3=very satisfied]; "Would you recommend this program to a friend if they had a child with anxiety?" [0=no, definitely not; 3=yes, definitely]; and "How pleased were you with how this program helped your child with anxiety" [0=quite displeased; 3=very pleased]. These items were averaged for each informant to generate a Caregiver Total Satisfaction Score (range: 0-3, higher scores reflect greater treatment satisfaction). For interpretation, mean scores <2 were interpreted as "Dissatisfied." Here we present the % of "Dissatisfied" caregivers at Post, across conditions.	Posttreatment (on average, 19 weeks)
Youth Treatment Satisfaction (Continuously Scored)	To assess Youth Treatment Satisfaction, youth > 8 years were administered a Satisfaction Scale that had them rate three items along 0-3 rating scales at posttreatment: "Overall, how satisfied [have you been/were you] with the services that you received?" [0=quite dissatisfied; 3=very satisfied]; "Would you recommend this program to a friend if they had anxiety?" [0=no, definitely not; 3=yes, definitely]; and "How pleased [have you been/were you] with how this program has helped you with anxiety" [0=quite displeased; 3=very pleased]. These three items were averaged for each informant to generate a Youth Total Satisfaction Score (range: 0-3, higher scores reflect greater satisfaction).	Posttreatment (on average, 19 weeks)
Youth Treatment Dissatisfaction (% of "Dissatisfied" Youth, Based on Dichotomous Coding of Dissatisfaction)	At posttreatment, youth were asked to rate three items developed for the present trial along 0-3 rating scales: "Overall, how satisfied were you with the services that you received?" [0=quite dissatisfied; 3=very satisfied]; "Would you recommend this program to a friend if they had anxiety?" [0=no, definitely not; 3=yes, definitely]; and "How pleased were you with how this program helped your anxiety" [0=quite displeased; 3=very pleased]. These items were averaged for each informant to generate a Youth Total Satisfaction Score (range: 0-3, higher scores reflect greater treatment satisfaction). For interpretation, mean scores <2 were interpreted as "Dissatisfied." Here we present the % of "Dissatisfied" youth at Post, across conditions.	Posttreatment (on average, 19 weeks)
Caregiver-Perceived Effectiveness	To assess Caregiver-Perceived Effectiveness, caregivers were asked on a 7-point scale "How effective do you think the program [has been/was] in treating your child's anxiety?" [0=very ineffective; 3=somewhat effective; 6=very effective]. Range of possible scores: 0-42; higher scores reflect greater perceived effectiveness.	Posttreatment (on average, 19 weeks)
Rate of Treatment Responders (% of Children Whose Posttreatment PARS Score Was at Least 35% Less Than Their Baseline PARS Score)	"Treatment Responder" defined as score reduction of at least 35% on the Pediatric Rating Scale (PARS). The PARS is a well-established clinician-rated instrument for assessing the frequency and severity of anxiety symptoms. Six global items are summed to generate a PARS Total score. The PARS has shown strong psychometric properties. PARS Total Score reductions of 35% or more are empirically defined as reflecting "Treatment Response". For the present study, PARS interviews were conducted by independent evaluators masked to treatment condition. Values here reflect the % of "Treatment Responders" at post, across conditions	Posttreatment (on average, 19 weeks)
Caregiver Homework Engagement (% of Weeks Caregiver Completed Assigned Homework)	Therapists completed weekly logs reporting whether study families on their caseloads completed the homework assigned in their previous session or support call. Homework completion reflects the percent of weeks across the trial in which all assigned homework was completed by caregiver, accounting for nesting and for covariates.	Posttreatment (on average, 19 weeks)
Youth Homework Engagement (% of Weeks Youth Completed Assigned Homework)	Therapists completed weekly logs reporting whether study families on their caseloads completed the homework assigned in their previous session or support call. Homework completion reflects the percent of weeks across the trial in which all assigned homework was completed by child/teen, accounting for nesting and for covariates.	Posttreatment (on average, 19 weeks)
Treatment Completion (% of Children Who Completed Their Treatment Program)	Therapists completed weekly logs reporting whether study families on their caseloads attended their scheduled sessions. Treatment Completion was defined for Therapist-Led CBT as attending 10 treatment sessions, and for Guided Online CBT Care as attending 4 support calls. For Guided Online CBT families, administrative backend data was also collected from the central server to further assess user/usage analytics. Values reflect % of completers within each condition.	Posttreatment (on average, 19 weeks)
Treatment Comprehension Difficulties (Caregiver Report)	Caregivers were asked at Posttreatment "How hard has the intervention been for [your family/your child] and you to understand?" [0=never hard; 3=sometimes hard; 6=very hard]. This item was developed for the present study (range: 0-6), with higher scores reflecting greater comprehension difficulties.	Posttreatment (on average, 19 weeks)
Difficulty Making Time for Treatment (Caregiver Report)	To assess Difficulties Making Time for Treatment caregivers were asked at at Posttreatment "How hard has it been for [your family/your child] to [make your schedule work for treatment sessions/find time to work on and complete the computer-based treatment modules online]?" [0=never a problem; 3=sometimes a problem; 6=often a problem]. This item was developed for the present study (range: 0-6), with higher scores reflecting greater difficulties making time for treatment.	Posttreatment (on average, 19 weeks)
Treatment Discomfort (Caregiver Report)	Caregivers were asked at Posttreatment "How comfortable has your [family/child] felt when [attending treatment sessions/completing the computer-based treatment modules online]?" [0=very comfortable; 3=sometimes comfortable; 6=very uncomfortable]. This item was developed for the present study (range: 0-6), with higher scores reflecting greater treatment discomfort.	Posttreatment (on average, 19 weeks)

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: Patient-Centered Outcomes Research Institute; Boston University; Johns Hopkins University; Massachusetts General Hospital; University of Washington; Seattle Children's Hospital; Nicklaus Children's Hospital f/k/a Miami Children's Hospital; Florida International University; South Boston Community Health Center
• Investigators: Principal Investigator: Jonathan S Comer, PhD, Florida International University; Principal Investigator: Donna B Pincus, PhD, Boston University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Actual): April 9, 2023
• Study Completion (Actual): June 6, 2024

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Adolescent; Child; Anxiety; Telehealth; Comparative Effectiveness; Cognitive Behavioral Therapy (CBT); Teen; iCBT; Telemental Health; Youth anxiety; Online CBT; Pediatric Anxiety; Internet-Delivered CBT; Therapist-Led CBT
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: H-37862; 6005686 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Patient-Centered Outcomes Data Repository will be used to facilitate responsible sharing of principal data from the trial for appropriate secondary use.
• IPD Sharing Time Frame: Will post by Dec 31, 2025. Will be available for at least 7 years (until Dec 30, 2032).
• IPD Sharing Access Criteria: Will be posted for public access and use on the Patient-Centered Outcomes Data Repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No