Home > Search Clinical Trials > All > Trial Details

Clinical Trial Details
Transitioning Emotionally and Academically to Middle School Successfully: Development of a Brief Intervention to Reduce Student Anxiety (TEAMSS)
Clinical Trial ( IRB ) #: 22-114OS-1
Title: Transitioning Emotionally and Academically to Middle School Successfully: Development of a Brief Intervention to Reduce Student Anxiety (TEAMSS)
Principal Investigator: Dr. Golda Ginsburg
Description: Project Summary/Abstract Title: Transitioning Emotionally and Academically to Middle School Successfully: Development of a Brief Intervention to Reduce Student Anxiety (TEAMSS) Topic: Social, Emotional and Behavioral Competence Project Type: Special Education Research Grant, CFDA Number: 84.324A,Social and Behavioral Outcomes to Support Learning, Development and Innovation Purpose: The transition from elementary to middle school is difficult for most students and specialized transition supports are critical for students receiving, or at risk of needing special education services. Excessive anxiety, part of the definition of "emotion disturbance" under IDEA, is the most common form of psychopathology and severely impairs academic functioning. Currently, no intervention exists to support this high risk group during their transition to middle school. The purpose of this application is to develop and assess the feasibility of a brief multi-component intervention, delivered by school clinicians, to reduce anxiety symptoms and improve academic and social functioning. The project proposes an iterative development process (i.e., expert review, two open trials, and pilot RCT) to achieve these goals. Project Activities: TEAMSS is an intervention for students in regular and/or special education classrooms with excessive anxiety as their primary concern. The development of TEAMSS will occur in three stages. In Stage 1, we will establish a development workgroup who will assist us in refining the intervention and study methods. In Stage 2, two sequential open trials of the revised protocol will be implemented at 3 middle schools with about 15-20 students with excessive anxiety. In Stage 3, a pilot RCT will occur at 4-6 middle schools and about 42 students will be enrolled. The RCT will occur in three phases: Phase 1, students will be assessed for eligibility (Baseline 1) at the end of elementary school and randomized to receive TEAMSS or enhanced usual care (EUC). In Phase 2, those in TEAMSS will begin group sessions within two weeks of starting middle school. At the end of the intervention (i.e., 10 weeks later), students randomized to both conditions will complete a post evaluation (i.e., December) and a follow-up evaluation in May (i.e., 5 months after their post evaluation). Products Expected: After engaging in an iterative process of designing, testing, and refining the intervention, it is expected that a fully formed intervention (manual, handouts, training materials), aimed at helping students with anxiety transition to middle school, will be available. Data from the RCT will inform schools and the field whether implementing a brief intervention to support the transition to middle school for students with anxiety is feasible and has an impact both on anxiety and academic outcomes. Dissemination of the intervention and study findings will occur at the local and national level. With respect to local dissemination, we will present to our participating school/districts, at statewide conferences and to the Board of Education. At the national level, research staff will publish findings in peer-reviewed journals and at present at local and national conferences (e.g., National Association of School Psychologists). Setting: Connecticut elementary schools from a mix of urban and suburban districts. Sample: A total of 90 fifth grade students with elevated anxiety symptoms or disorders will participate in this study. Within the participating CT districts there are 51 elementary schools and 20,000 students. The student body within CT is diverse in terms of gender, socioeconomic status, and racial/ethnic background (12.3% African American, 22.1% Hispanic/Latino, 57.3% Caucasian, 4.8% Asian, 2.5% two or more races; 32.9% receive free/reduced priced meals). Intervention to be developed: TEAMSS will be an innovative program based on empirically supported cognitive behavioral strategies for anxiety reduction. The initial version of TEAMSS includes a six session student group, two parent group sessions, and teacher consultation meetings. The content of TEAMSS includes anxiety psychoeducation, behavioral exposure, cognitive restructuring, relaxation strategies and social and organizational skills for students, as well as strategies for parents and teachers to reduce anxiety-promoting behaviors. Control: To ensure adequate recruitment and retention, the control condition during the pilot RCT will be EUC, 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. Primary research method: This project will be implemented in three stages. In Stage 1a "TEAMSS Development Workgroup" (TDW), comprised of national experts and school personnel, will provide input on the intervention and study protocol. Stage 2 involves two sequential open trials at 3 middle schools with about 15-20 students with excessive anxiety. In Stage 3a pilot RCT comparing TEAMSS and EUC with 4-6 school-based clinicians, at 4-6 middle schools and about 42 students will be conducted. Key outcomes measures: Using a multi-method multi-informant approach, key outcomes will assess feasibility and acceptability (e.g., clinician knowledge and fidelity of TEAMSS, satisfaction, recruitment/retention) and student outcomes (e.g., social-emotional, behavioral, and educational outcomes). Exploratory outcomes will assess mediators outlined in the proposed theory of change and data on costs will be collected. Data analytic strategy: Feasibility and acceptability analyses will be descriptive (e.g., recruitment, adherence, satisfaction). In the RCT, impact of TEAMSS 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: Measures will assess TEAMSS costs (i.e., to schools, districts) as well as savings resulting from impacts on academics, special education and specialty mental health service utilization. We will obtain data on TEAMSS training and implementation costs at one of the participating schools, and use these data to estimate the overall costs of implementing and delivering TEAMSS.
Classification:
  Psychiatry - Child and Adolescent
  Stress Disorders
Eligibility Criteria: Check with study contact
How to Contact: Kevin Rodriguez. Telephone: 860-523-3789. Email: kerodriguez@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.