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Clinical Trials/NCT03707158
NCT03707158CompletedNot Applicable

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

Boston Medical Center8 sites in 1 country305 target enrollmentStarted: October 8, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
305
Locations
8
Primary Endpoint
Child Anxiety Life Interference Scale (CALIS), Caregiver Report

Study Overview

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..

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Independent evaluators (IEs) are masked to treatment assignments.

Eligibility Criteria

Ages
7 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •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

Arms & Interventions

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)

Intervention: Guided Online CBT (Behavioral)

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.

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

Outcomes

Primary Outcomes

Child Anxiety Life Interference Scale (CALIS), Caregiver Report

Time Frame: 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

Time Frame: 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.

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

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

  • Youth Homework Engagement (% of Weeks Youth Completed Assigned Homework)(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))
  • Caregiver Homework Engagement (% of Weeks Caregiver Completed Assigned Homework)(Posttreatment (on average, 19 weeks))
  • Treatment Completion (% of Children Who Completed Their Treatment Program)(Posttreatment (on average, 19 weeks))
  • Treatment Comprehension Difficulties (Caregiver Report)(Posttreatment (on average, 19 weeks))
  • Difficulty Making Time for Treatment (Caregiver Report)(Posttreatment (on average, 19 weeks))
  • Treatment Discomfort (Caregiver Report)(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))
  • 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))
  • Caregiver Treatment Satisfaction (Continuously Scored)(Posttreatment (on average, 19 weeks))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

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