Project Activities
The researchers planned to conduct a randomized efficacy trial of M-CBT on students with anxiety in urban schools, delivered by school-based clinicians, to determine its impact on child, parent, and teacher ratings of anxiety and measures of academic performance. The research team planned to closely monitor treatment integrity (adherence, competence, and differentiation); explore predictors, moderators, and mediators of intervention response; and examine the cost-effectiveness of the intervention.
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 at risk for and receiving special education services who are referred to school-based mental health clinics. A total of 46 volunteer clinicians (one per school) will participate.
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. After psychoeducation and exposure modules take place, the remaining sequence of administering the modules is flexible. 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 personnel (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
Students in the usual care (UC) control 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; the Screen for Child Anxiety-Related Emotional Disorders, child and parent versions; the Clinical Global Impression, Severity and Improvement scales,and the Children's Automatic Thoughts Scale. 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 assessment. 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.
Cost analysis strategy
The team will 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.
People and institutions involved
IES program contact(s)
Products and publications
ERIC Citations: Find available citations in ERIC for this award here and here.
Journal articles
Caron, E., Muggeo, M. A., Souer, H. R., Pella, J. E., & Ginsburg, G. S. (2019). Concordance between clinician, supervisor, and observer ratings of therapeutic competence in CBT and treatment as usual: Does clinician competence or supervisor session observation improve agreement? Behavioural and Cognitive Psychotherapy, 48(3), 350-363. https://doi.org/10.1017/s1352465819000699
Ginsburg, G. S., Muggeo, M., Caron, E. B., Souer, H. R., & Pikulski, P. J. (2019). Exploring treatment as usual for pediatric anxiety disorders among school-based clinicians. School Mental Health, 11(4), 719-727. https://doi.org/10.1007/s12310-019-09331-3
Ginsburg, G. S., Pella, J. E., Pikulski, P. J., Tein, J.-Y., & Drake, K. L. (2020). School-based treatment for anxiety research study (STARS): A randomized controlled effectiveness trial. Journal of Abnormal Child Psychology, 48(3), 407-417. https://doi.org/10.1007/s10802-019-00596-5
LoCurto, J., Pella, J., Chan, G., & Ginsburg, G. (2020). School-based clinicians sustained use of a cognitive behavioral treatment for anxiety disorders. School Mental Health, 12(4), 677-688. https://doi.org/10.1007/s12310-020-09381-y
LoCurto, J., Pella, J. E., Chan, G., & Ginsburg, G. S. (2021). Caregiver report of the utilization of school-based services and supports among clinically anxious youth. Journal of Emotional and Behavioral Disorders, 29(2), 93-104. https://doi.org/10.1177/1063426620942155
Pella, J. E., Ginsburg, G. S., Casline, E., Pikulski, P. J., & Drake, K. L. (2018). Children's perceptions of barriers to session attendance in school-based treatment for anxiety. School Mental Health, 10(4), 417-427. https://doi.org/10.1007/s12310-018-9253-8
Pella, J. E., Slade, E. P., Pikulski, P. J., & Ginsburg, G. S. (2020). Pediatric anxiety disorders: A cost of illness analysis. Journal of Abnormal Child Psychology, 48(4), 551-559. https://doi.org/10.1007/s10802-020-00626-7
Pikulski, P. J., Pella, J. E., Casline, E. P., Hale, A. E., Drake, K., & Ginsburg, G. S. (2020). School connectedness and child anxiety. Journal of Psychologists and Counsellors in Schools, 30(1), 13-24. https://doi.org/10.1017/jgc.2020.3
Additional project information
Previous award details:
Supplemental information
Co-Principal Investigator: Drake, Kelly
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