Previous Institution: Johns Hopkins University
Previous Award Number: R324A120405

Co-Principal Investigator: Kelly Drake

Purpose: Anxiety disorders are the most common childhood psychiatric conditions and are known to severely impair children's academic, social, and behavioral functioning in school. Approximately 11–15 percent of youth receiving special education services (generally under the category of emotional disturbance) and 10–20 percent of youth at risk for special education have excessive anxiety requiring treatment. Despite the growing efficacy of cognitive-behavioral treatment for anxiety, this intervention is not widely used in schools. The primary purpose of this research is to evaluate the efficacy of a modular cognitive-behavioral intervention (M-CBT), compared to usual care (UC), on reducing excessive anxiety and improving student academic, social, and behavioral performance in school.

Project Activities: The researchers will conduct a randomized efficacy trial of M-CBT in urban schools, delivered by school-based clinicians. The study uses a 2 (intervention: M-CBT versus UC) x 4 (assessment period: pre-treatment, 12 weeks post treatment, 3 month follow up, and natural termination) randomized controlled design with 368 anxious youth, 7–17 years of age, and 46 school-based clinicians. Primary outcomes include child, parent, and teacher ratings of anxiety and measures of academic performance. Treatment integrity (i.e., adherence, competence, and differentiation) will be closely monitored via audiotaped therapy sessions. Exploratory analyses will examine predictors, moderators, and mediators of intervention response. In addition, the research team will examine the cost-effectiveness of the intervention.

Products: The products of this project will include evidence of the efficacy of M-CBT for youth ages 7–17 with or at risk for disabilities, peer-reviewed publications, and presentations.

Structured Abstract

Setting: The research will take place in urban elementary, middle, and high schools in Maryland.

Sample: A total of 368 students, ages 7–17, with primary diagnoses of generalized, social, and/or separation anxiety disorders will participate. Students will include those receiving special education services and at risk for needing special education who are referred to school-based mental health clinics. A total of 46 volunteer clinicians (one per school) will participate.

Intervention: M-CBT is a 12-session intervention designed to reduce anxiety. M-CBT consists of seven core modules: psychoeducation, exposure, rewards, cognitive restructuring, problem-solving, somatic/relaxation skills, and relapse prevention. Parallel parent modules are also included. M-CBT is a "modular" treatment, meaning that the sequence of administering the modules is flexible, with the exception that psychoeducation and exposure occur as the first and second modules, respectively. All modules are designed to be covered within 12 weeks and therapists may emphasize those modules that are most relevant for each child.

Research Design and Methods: This study uses a block randomized controlled trial comparing M-CBT to usual care (UC). The research team will form blocks of two clinicians with similar personal (e.g., years of experiences) and school assignment characteristics (e.g., school size). Within each block, one clinician/school will be randomized to each treatment condition. Clinicians randomized to UC will be trained in M-CBT after they complete usual care treatment with seven to nine students.

Control Condition: Usual care will serve as the comparison group for M-CBT. Students in this condition will be provided with interventions that do not explicitly include CBT strategies and will reflect the training and services that clinicians already provide (e.g., art, play or supportive therapy). Careful training, monitoring, and supervision will be conducted to assess adequate differentiation between the M-CBT and UC interventions.

Key Measures: A variety of outcome measures will be used to assess behavioral and academic functioning. Anxiety diagnosis and symptoms will be assessed using the Anxiety Disorders Interview Schedule for DSM-IV, Parent and Child Versions (ADIS-IV-C), the Screen for Child Anxiety-Related Emotional Disorders, Child and Parent Versions (SCARED), the Clinical Global Impression — Severity (CGI-S) and Improvement (CGI-I) Scales, and Children's Automatic Thoughts Scale (CATS). Academic, social, and behavioral functioning will be assessed via a combination of assessments that include school records, state achievement assessments, norm-referenced tests of achievement and cognition, and teacher and parent ratings of behavior.

Data Analytic Strategy: The efficacy of the intervention will be examined using three analytical approaches. Random effects or mixed effects analyses of covariance (for continuous measures) or logistic regression (for categorical measures), controlling for possible pretest or baseline differences, will be used at posttest and 3-month follow-up. In the second approach, the team will use all of the repeated anxiety or school functioning measures at pretest, posttest, 3-month follow-up, and at termination together within a 3-level random effects model. The third approach will examine the intervention effect on the time interval between the pretest and termination with discrete-time survival analyses.

The team will also estimate incremental cost-effectiveness ratios for differences between M-CBT and UC using the following efficacy outcomes: (a) number of students who meet clinical criteria for anxiety, (b) anxiety symptoms, (c) days of school attendance, (d) classroom behaviors, and (e) treatment satisfaction.