Kids FACE FEARS Comparative Effectiveness Research

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.

Conditions

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• South Boston Community Health Center

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Nicklaus Children's Hospital f/k/a Miami Children's Hospital

  collaborator OTHER

• Boston University

  collaborator OTHER

• Florida International University

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• Boston Medical Center

  lead OTHER

Principal Investigators

• Jonathan S Comer, PhD · Florida International University

• Donna B Pincus, PhD · Boston University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-08

Primary Completion

2023-04-09

Completion

2024-06-06

Countries

• United States

Study Locations