Clinical trial NCT03707158: Kids FACE FEARS Comparative Effectiveness Research
Official title: Kids Formats of Anxiety Care Effectiveness Study For Extending the Acceptability and Reach of Services (Kids FACE FEARS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Anxiety
Anxiety Disorders
Anxiety
Anxiety Symptoms
Anxiety, Mild to Moderate
Pediatric Anxiety Disorders
Keywords: Cognitive Behavioral Therapy (CBT)
Online CBT
Telehealth
Anxiety
Child
Therapist-Led CBT
Pediatric Anxiety
Internet-Delivered CBT
iCBT
Telemental Health
Adolescent
Teen
Youth anxiety
Comparative Effectiveness
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Massachusetts General Hospital
name: South Boston Community Health Center
name: Johns Hopkins University
name: Nicklaus Children's Hospital f/k/a Miami Children's Hospital
name: Boston University
name: Florida International University
name: University of Washington
name: Seattle Children's Hospital
First posted: 2018-10-16
Enrollment: 305
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic Comparative Effectiveness RCT; Type I Hybrid Effectiveness and Implementation Study
Primary purpose: TREATMENT

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?

Eligibility 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

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

Primary outcomes:
measure: Promis Pediatric Short Form v. 2.0-Anxiety (Parent Proxy/Caregiver Report)
timeFrame: Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)
measure: Promis Pediatric Short Form v. 2.0-Anxiety (Pediatric/Youth Self-Report)
timeFrame: Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)
measure: Child Anxiety Life Interference Scale (CALIS), Caregiver Report
timeFrame: Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)
measure: Child Anxiety Life Interference Scale (CALIS), Youth Self-Report
timeFrame: Baseline, Midtreatment (on average, 8 weeks), Posttreatment (on average, 19 weeks), Follow-up (on average, 55 weeks)
Secondary outcomes:
measure: Caregiver Treatment Satisfaction (Continuously Scored)
timeFrame: Posttreatment (on average, 19 weeks)
measure: Caregiver Treatment Dissatisfaction (% of "Dissatisfied" Caregivers, Based on Dichotomous Coding of Dissatisfaction)
timeFrame: Posttreatment (on average, 19 weeks)
measure: Youth Treatment Satisfaction (Continuously Scored)
timeFrame: Posttreatment (on average, 19 weeks)
measure: Youth Treatment Dissatisfaction (% of "Dissatisfied" Youth, Based on Dichotomous Coding of Dissatisfaction)
timeFrame: Posttreatment (on average, 19 weeks)
measure: Caregiver-Perceived Effectiveness
timeFrame: Posttreatment (on average, 19 weeks)
measure: Rate of Treatment Responders (% of Children Whose Posttreatment PARS Score Was at Least 35% Less Than Their Baseline PARS Score)
timeFrame: Posttreatment (on average, 19 weeks)
measure: Caregiver Homework Engagement (% of Weeks Caregiver Completed Assigned Homework)
timeFrame: Posttreatment (on average, 19 weeks)
measure: Youth Homework Engagement (% of Weeks Youth Completed Assigned Homework)
timeFrame: Posttreatment (on average, 19 weeks)
measure: Treatment Completion (% of Children Who Completed Their Treatment Program)
timeFrame: Posttreatment (on average, 19 weeks)
measure: Treatment Comprehension Difficulties (Caregiver Report)
timeFrame: Posttreatment (on average, 19 weeks)
measure: Difficulty Making Time for Treatment (Caregiver Report)
timeFrame: Posttreatment (on average, 19 weeks)
measure: Treatment Discomfort (Caregiver Report)
timeFrame: Posttreatment (on average, 19 weeks)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Nicklaus Children's Hospital
state: Florida
city: Miami
country: United States
facility: Florida International University
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: South Boston Community Health Center
state: Massachusetts
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Florida International University
name: Jonathan S Comer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Donna B Pincus, PhD
role: PRINCIPAL_INVESTIGATOR
References: