Kids FACE FEARS Comparative Effectiveness Research

Boston Medical Center305 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

305

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.

Guided Online CBTBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Nicklaus Children's Hospital

Miami, Florida, United States

Florida International University

Miami, Florida, United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

South Boston Community Health Center

Boston, Massachusetts, United States

Harborview Medical Center

Seattle, Washington, United States

Seattle Children's Hospital

Seattle, Washington, United States

Outcomes

Primary Outcomes

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)

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)

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)

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)

Secondary Outcomes

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).