Project Activities
The development of TRAMSS will occur in three stages. In Stage 1, a development workgroup will provide feedback on the intervention and study methods. In Stage 2, two sequential open trials of the revised protocol will be implemented at 3 middle schools with 30 students with excessive anxiety. In Stage 3, a pilot RCT will occur at 4–6 middle schools and 60 students will be enrolled. The RCT will occur in three phases. In phase 1, students will be assessed for eligibility (Baseline 1) at the end of elementary school and randomized to receive TRAMSS or enhanced usual care. In phase 2, students in both groups will be re-assessed at the beginning of middle school (Baseline 2) and those in TRAMSS will begin group sessions within two weeks of starting middle school. In phase 3, students randomized to both conditions will complete a post evaluation in approximately December (i.e., 10 weeks after intervention start) and a follow-up evaluation in May (i.e., 5 months after their post evaluation).
Structured Abstract
Setting
The research will take place in urban and suburban elementary schools in Connecticut.
Sample
A total of 90 fifth grade students with elevated anxiety symptoms or disorders will participate in this study.
Intervention
The initial version of TRAMSS includes student groups, two parent group sessions, and teacher consultation meetings. This intervention was designed to be implemented by a school-based mental health clinician and contains two core modules delivered in 5th grade to help students become familiar with the middle school environment and six core modules delivered in 6th grade to help students understand, manage, and cope with anxiety. The content of TRAMSS includes anxiety psychoeducation and relaxation, behavioral exposure, cognitive restructuring, social skills, organizational skills for students, and planning for the future, as well as strategies for parents to reduce anxiety-promoting behaviors.
Research design and methods
The development of TRAMSS will involve an iterative process in which versions of the intervention and its implementation procedures will be conducted sequentially and refined in response to feedback from expert consultants, school clinicians, special education personnel, students and parents. This project will be implemented in three stages. In Stage 1 a TRAMSS Development Workgroup" (TDW), comprised of national experts and school personnel, will provide input via TDW meetings on the intervention and study protocol. Stage 2 involves two sequential open trials at 3 middle schools with 30 students with excessive anxiety. This stage will allow for trial runs of all aspects of the protocol and will identify obstacles to implementation, feasibility, and acceptability. After each open trial feedback will be collected from students, parents, and clinicians (via interviews and standardized measures. In Stage 3 a pilot RCT comparing TRAMSS and EUC with 4–6 school-based clinicians, at 4–6 middle schools and 60 students will be conducted.
Control condition
The control condition during the pilot RCT will be enhanced business as usual condition, which will include written materials for families (e.g., resources on student anxiety, tip sheets on successful transitions to middle school) and formal visits with the middle school clinician in the spring of last year of elementary school.
Key measures
Data will be collected from multiple informants (e.g., child, parent, clinician, teacher) using multiple formats (e.g., rating scales, interviews, school records). A variety of measures will be used to assess feasibility and acceptability (e.g., clinician knowledge and fidelity of TRAMSS, satisfaction, recruitment/retention). Student anxiety symptoms will be measured with the Screen for Child Anxiety-Related Emotional Disorders, Child and Parent Versions (SCARED), the Anxiety Disorders Interview Schedule for DSM-V, Parent and Child Versions, the Clinical Global Impression – Severity (CGI-S) and Improvement (CGI-I) Scales, the Child Anxiety Impact Scale (CAIS) and the School Anxiety Scale – Teacher Report (SAS). Academic and classroom functioning will be measured with the Academic Competence Evaluation Scale (ACES) and math and reading subtests from Woodcock-Johnson IV Tests of Achievement and Cognitive Abilities. School Recordswill be used to examine grades, attendance, referrals for special education, grade retention, and referrals for disciplinary actions. Data on costs will also be collected.
Data analytic strategy
Feasibility and acceptability analyses will be descriptive (e.g., recruitment, adherence, satisfaction). In the RCT, impact of TRAMSS vs EUC on key outcomes will use mixed effect models. Covariates may be included in the analysis to correct for imbalance if it is deemed necessary.
Cost analysis strategy
Measures will assess TRAMSS costs (i.e., to schools and districts) as well as savings resulting from impacts on academics, special education, and specialty mental health service utilization. The research team will obtain data on TRAMSS training and implementation costs at one of the participating schools and use these data to estimate the overall costs of implementing and delivering TRAMSS.
Products and publications
Products: This project will result in a fully developed TRAMSS intervention delivered by school clinicians to address excessive anxiety in students transitioning to middle school and evidence of usability, feasibility, and promise for improving student social-emotional, behavioral, and educational outcomes. The project will also result in peer-reviewed publications and presentations as well as additional dissemination products that reach education stakeholders, such as practitioners and policymakers.
Supplemental information
Co-Principal Investigator: LoCurto, Jamie
Questions about this project?
To answer additional questions about this project or provide feedback, please contact the program officer.