Kids FACE FEARS Comparative Effectiveness Research
Purpose
The Kids FACE FEARS (Kids Face-to-face And Computer-Enhanced Formats Effectiveness study for Anxiety and Related Symptoms) is a large-scale, streamlined, pragmatic Randomized Controlled Trial (RCT) evaluating face-to-face (therapist led office based or telehealth) vs. self-administered online cognitive-behavioral therapy (CBT) for the treatment of 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. Patient-centered outcomes will be evaluated across a one-year follow-up period; parents, patients, providers, and other key stakeholders will be actively engaged throughout all aspects of the research.
Conditions
- Child Anxiety
- Anxiety Disorder of Adolescence
Eligibility
- Eligible Ages
- Between 7 Years and 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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. Parent or legal guardian is 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. Hired therapists or program staff at primary care sites or co-located sites participating in the study
Exclusion Criteria
- Severe anxiety, as indicated by suicidal thoughts or behaviors (requiring higher level of care in the past 6 months) and/or poor functioning defined as anxiety-related inability to attend school 50% of days in the past month (or, if summer, the last month of school attended), or requiring higher level of care as determined by a clinician 2. Required psychiatric hospitalization or residential care in the past 3 months 3. History of diagnosed severe autism spectrum disorder (not verbal) or intellectual disability (self-reported, must be reported by parent if under the age of 18 or by primary care physician) 4. Currently undergoing cognitive behavioral therapy or planning to continue a different psychotherapy for anxiety during the time of the study (self-reported, must be reported by parent if under the age of 18) 5. Treatment participants not fluent in English or Spanish 6. If over the age of 12, child has had a problem with drugs and/or alcohol within the past 6 months or at the time of screening (self-reported, must be reported by parent if under the age of 18) 7. Cognitively impaired youth will not be included based on clinical judgment at the time of screening (Primary care staff will be consulted at time of referral) 8. Child is ward of the state
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Web-based CBT |
The online, multimedia suite of Cool Kids CBT web-based programs for youth anxiety is a supported, largely self-administered online digital cognitive-behavioral therapy anxiety management intervention, with adjunctive therapist phone support. Treatment content runs directly parallel to that included in the therapist-led Cool Kids face-to-face suite of interventions. The online suite of interventions is comprised of two developmentally tailored programs, depending on the age of the child. |
|
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Active Comparator Face-to-Face CBT |
The Cool Kids suite of face-to-face (office-based or telehealth) CBT-based programs for youth anxiety is a well-supported therapist-led, clinic-based anxiety management intervention. The face-to-face cognitive-behavioral therapy treatment content runs directly parallel to that included in the Cool Kids online suite of interventions. The face-to-face suite of interventions is comprised of two developmentally tailored programs, depending on the age of the child. |
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More Details
- Status
- Completed
- Sponsor
- Boston Medical Center
Study Contact
Detailed Description
Anxiety disorders are among the most common and impairing psychiatric disorders to affect children and adolescents. Cognitive Behavioral Therapy (CBT) is an effective psychological treatment for youth anxiety, with roughly 60-80% 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. 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 who are trained in providing mental health treatment, and a lack of information on the optimal methods of treating anxiety in pediatric settings. Two evidence-based strategies for delivering CBT for youth with mild to moderate anxiety in pediatric settings are (1) face-to-face CBT delivered by therapists within pediatric health care in an office-based setting or via telehealth and (2) online delivery of CBT skills to youth and families. Importantly, however, there are no data on the relative effectiveness of these two treatment formats in real-world settings, and no information on which patient subgroups benefit most from which formats in patients in real-world practice. The study design entails a large-scale, streamlined, pragmatic, Randomized Controlled Trial (RCT), in which eligible anxious youth presenting to pediatric primary care settings will be randomly assigned to face-to-face versus online Cool Kids suite of CBT intervention for youth anxiety and monitored for up to one year post-intervention. Outcomes for each participant will be monitored across four assessment points, corresponding to baseline, mid-treatment, post-treatment, and 1 year post-baseline. Long-term outcomes associated with face-to-face versus online CBT will be evaluated over a 1-year period post-intervention. We will use the well-established Cool Kids suite of face-to-face and online anxiety CBT protocols within pediatric primary 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. Therapists embedded within pediatric primary care settings and mental health clinics co-located with primary care will provide all services. All participants will be identified and referred for enrollment from pediatric health settings. This study addresses three critical yet unanswered questions related to improving the delivery of treatment and outcomes for anxiety in pediatric primary care. 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 decisions regarding clinical practice and implementation strategies for the treatment of childhood anxiety: 1. What is the relative effectiveness of implementing therapist-led (face-to-face or telehealth) versus self-administered online formats of CBT to treat youth anxiety in pediatric health care? 2. How do factors such as clinical severity, treatment preference, socioeconomic status, computer literacy, distance to clinic, organizational readiness, or medical home status moderate outcomes across treatment formats? Which patient subgroups might benefit most from which formats? 3. What are the barriers and facilitators to delivering this care in pediatric health care settings and for the diverse patient populations served?