Kids FACE FEARS Comparative Effectiveness Research

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03707158

Enrollment

305

Registered

2018-10-16

Start date

2019-10-08

Completion date

2024-06-06

Last updated

2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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?

Interventions

BEHAVIORALTherapist-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.

BEHAVIORALGuided 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Independent evaluators (IEs) are masked to treatment assignments.

Intervention model description

Pragmatic Comparative Effectiveness RCT; Type I Hybrid Effectiveness and Implementation Study

Eligibility

Sex/Gender

ALL

Age

7 Years to 18 Years

Healthy volunteers

Inclusion 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 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

Design outcomes

Primary

Measure	Time frame	Description
Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)	Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)	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.
Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)	Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)	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.
Child Anxiety Life Interference Scale (CALIS), Caregiver Report	Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)	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.
Child Anxiety Life Interference Scale (CALIS), Youth Self-Report	Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)	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.

Secondary

Measure	Time frame	Description
Caregiver-Perceived Effectiveness	Posttreatment (on average, 19 weeks)	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.
Rate of Treatment Responders (% of Children Whose Posttreatment PARS Score Was at Least 35% Less Than Their Baseline PARS Score)	Posttreatment (on average, 19 weeks)	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
Caregiver Homework Engagement (% of Weeks Caregiver Completed Assigned Homework)	Posttreatment (on average, 19 weeks)	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.
Youth Homework Engagement (% of Weeks Youth Completed Assigned Homework)	Posttreatment (on average, 19 weeks)	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.
Caregiver Treatment Satisfaction (Continuously Scored)	Posttreatment (on average, 19 weeks)	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).
Treatment Comprehension Difficulties (Caregiver Report)	Posttreatment (on average, 19 weeks)	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.
Difficulty Making Time for Treatment (Caregiver Report)	Posttreatment (on average, 19 weeks)	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.
Treatment Discomfort (Caregiver Report)	Posttreatment (on average, 19 weeks)	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.
Treatment Completion (% of Children Who Completed Their Treatment Program)	Posttreatment (on average, 19 weeks)	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.
Caregiver Treatment Dissatisfaction (% of Dissatisfied Caregivers, Based on Dichotomous Coding of Dissatisfaction)	Posttreatment (on average, 19 weeks)	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.
Youth Treatment Satisfaction (Continuously Scored)	Posttreatment (on average, 19 weeks)	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).
Youth Treatment Dissatisfaction (% of Dissatisfied Youth, Based on Dichotomous Coding of Dissatisfaction)	Posttreatment (on average, 19 weeks)	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.

Countries

United States

Participant flow

Pre-assignment details

Enrollment numbers refer to # of dyads, not # of individuals--that is, a treated child and their caregiver together count as 1 enrollment. Values in table below refer to # of dyads.

Participants by arm

Arm	Count
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) 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.	156
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. 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.	149
Total	305

Withdrawals & dropouts

Period	Reason	FG000	FG001
Follow-up	Lost to Follow-up	19	18
Follow-up	Withdrawal by Subject	13	6
Midtreatment	Lost to Follow-up	16	7
Midtreatment	Withdrawal by Subject	28	19
Posttreatment	Lost to Follow-up	0	5

Baseline characteristics

Characteristic	Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Total	Guided Online CBT (With Minimal Therapist Involvement)
Age, Continuous	42.07 years STANDARD_DEVIATION 6.5	11.9 years STANDARD_DEVIATION 2.8	42.65 years STANDARD_DEVIATION 6.9
Age, Customized 13-18 years old	50 Participants	102 Participants	52 Participants
Age, Customized 7-12 years old	99 Participants	203 Participants	104 Participants
Caregiver Education Completed College	39 Participants	85 Participants	46 Participants
Caregiver Education Completed Graduate School	37 Participants	78 Participants	41 Participants
Caregiver Education High School or Less	61 Participants	119 Participants	58 Participants
Caregiver Education Not reported	12 Participants	23 Participants	11 Participants
Caregiver Nativity Caregiver Foreign Born	56 Participants	120 Participants	64 Participants
Caregiver Nativity Caregiver U.S. Born	93 Participants	185 Participants	92 Participants
Household Resource Insecurity Baseline Household Resource Insecurity	34 Participants	62 Participants	28 Participants
Household Resource Insecurity No Baseline Household Resource Insecurity	115 Participants	243 Participants	128 Participants
Non-English Language Spoken in Home No	68 Participants	141 Participants	73 Participants
Non-English Language Spoken in Home Not reported	2 Participants	3 Participants	1 Participants
Non-English Language Spoken in Home Yes	79 Participants	161 Participants	82 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native & Native Hawaiian/Other Pacific Islander	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Asian	7 Participants	15 Participants	8 Participants
Race/Ethnicity, Customized Asian & Middle Eastern/North African	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Black & American Indian/Alaskan Native	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Black & Asian	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Black & Hispanic/Latine	5 Participants	9 Participants	4 Participants
Race/Ethnicity, Customized Black & Hispanic/Latine & American Indian/Alaskan Native	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Black & Middle Eastern/North African	1 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Black or African American	8 Participants	22 Participants	14 Participants
Race/Ethnicity, Customized Hispanic/Latine	70 Participants	141 Participants	71 Participants
Race/Ethnicity, Customized Hispanic/Latine & American Indian/Alaskan Native	1 Participants	3 Participants	2 Participants
Race/Ethnicity, Customized Hispanic/Latine & Asian	1 Participants	4 Participants	3 Participants
Race/Ethnicity, Customized Middle Eastern or North African (MENA)	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Non-Hispanic White	50 Participants	100 Participants	50 Participants
Race/Ethnicity, Customized Not Reported	1 Participants	3 Participants	2 Participants
Region of Enrollment United States	149 participants	305 participants	156 participants
Sex/Gender, Customized Cis Female	85 Participants	187 Participants	102 Participants
Sex/Gender, Customized Cis Male	56 Participants	108 Participants	52 Participants
Sex/Gender, Customized Female	125 Participants	258 Participants	133 Participants
Sex/Gender, Customized Male	13 Participants	26 Participants	13 Participants
Sex/Gender, Customized Not Reported	11 Participants	21 Participants	10 Participants
Sex/Gender, Customized Trans or NonBinary	8 Participants	10 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 156	0 / 149
other Total, other adverse events	0 / 156	0 / 149
serious Total, serious adverse events	0 / 156	0 / 149

Outcome results

Primary

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.

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

Population: Intention-to-treat analyses

Arm	Measure	Group	Value (MEAN)	Dispersion
Guided Online CBT (With Minimal Therapist Involvement)	Child Anxiety Life Interference Scale (CALIS), Caregiver Report	Midtreatment	20.2 score on a scale	Standard Deviation 12.1
Guided Online CBT (With Minimal Therapist Involvement)	Child Anxiety Life Interference Scale (CALIS), Caregiver Report	Baseline	26.3 score on a scale	Standard Deviation 12.2
Guided Online CBT (With Minimal Therapist Involvement)	Child Anxiety Life Interference Scale (CALIS), Caregiver Report	Posttreatment	18.9 score on a scale	—
Guided Online CBT (With Minimal Therapist Involvement)	Child Anxiety Life Interference Scale (CALIS), Caregiver Report	Follow-up	17.3 score on a scale	Standard Deviation 12.2
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Child Anxiety Life Interference Scale (CALIS), Caregiver Report	Follow-up	17.6 score on a scale	Standard Deviation 12.2
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Child Anxiety Life Interference Scale (CALIS), Caregiver Report	Posttreatment	19.3 score on a scale	Standard Deviation 12.2
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Child Anxiety Life Interference Scale (CALIS), Caregiver Report	Baseline	26.8 score on a scale	Standard Deviation 12.2
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Child Anxiety Life Interference Scale (CALIS), Caregiver Report	Midtreatment	20.5 score on a scale	Standard Deviation 12.1

Primary

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.

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

Population: Intention-to-treat analyses

Arm	Measure	Group	Value (MEAN)	Dispersion
Guided Online CBT (With Minimal Therapist Involvement)	Child Anxiety Life Interference Scale (CALIS), Youth Self-Report	Midtreatment	10.6 score on a scale	Standard Deviation 7.1
Guided Online CBT (With Minimal Therapist Involvement)	Child Anxiety Life Interference Scale (CALIS), Youth Self-Report	Posttreatment	10.6 score on a scale	Standard Deviation 7.5
Guided Online CBT (With Minimal Therapist Involvement)	Child Anxiety Life Interference Scale (CALIS), Youth Self-Report	Follow-up	9.5 score on a scale	Standard Deviation 8.1
Guided Online CBT (With Minimal Therapist Involvement)	Child Anxiety Life Interference Scale (CALIS), Youth Self-Report	Baseline	13.1 score on a scale	Standard Deviation 7.5
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Child Anxiety Life Interference Scale (CALIS), Youth Self-Report	Follow-up	10.0 score on a scale	Standard Deviation 8.1
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Child Anxiety Life Interference Scale (CALIS), Youth Self-Report	Baseline	13.4 score on a scale	Standard Deviation 7.5
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Child Anxiety Life Interference Scale (CALIS), Youth Self-Report	Posttreatment	10.1 score on a scale	Standard Deviation 7.5
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Child Anxiety Life Interference Scale (CALIS), Youth Self-Report	Midtreatment	11.1 score on a scale	Standard Deviation 7.1

Primary

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.

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

Population: Intention-to-treat

Arm	Measure	Group	Value (MEAN)	Dispersion
Guided Online CBT (With Minimal Therapist Involvement)	Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)	Baseline	65.7 T-Score	Standard Deviation 8.3
Guided Online CBT (With Minimal Therapist Involvement)	Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)	Posttreatment	57.9 T-Score	Standard Deviation 9.7
Guided Online CBT (With Minimal Therapist Involvement)	Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)	Follow-up	56.2 T-Score	Standard Deviation 10.2
Guided Online CBT (With Minimal Therapist Involvement)	Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)	Midtreatment	59.2 T-Score	Standard Deviation 9.4
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)	Follow-up	55.9 T-Score	Standard Deviation 10.2
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)	Midtreatment	59.1 T-Score	Standard Deviation 9.4
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)	Posttreatment	57.7 T-Score	Standard Deviation 9.7
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)	Baseline	66.0 T-Score	Standard Deviation 8.3

Primary

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.

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

Population: Intention-to-treat analyses

Arm	Measure	Group	Value (MEAN)	Dispersion
Guided Online CBT (With Minimal Therapist Involvement)	Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)	Posttreatment	54.7 T scores	Standard Deviation 9.4
Guided Online CBT (With Minimal Therapist Involvement)	Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)	Midtreatment	55.6 T scores	Standard Deviation 9.6
Guided Online CBT (With Minimal Therapist Involvement)	Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)	Follow-up	54.4 T scores	Standard Deviation 10
Guided Online CBT (With Minimal Therapist Involvement)	Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)	Baseline	61.4 T scores	Standard Deviation 9.5
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)	Follow-up	54.2 T scores	Standard Deviation 10
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)	Midtreatment	56.4 T scores	Standard Deviation 9.6
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)	Posttreatment	54.4 T scores	Standard Deviation 9.4
Therapist-Led CBT (Telehealth, Office-based, or Hybrid Delivered)	Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)	Baseline	61.2 T scores	Standard Deviation 9.5

Secondary

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.