Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)

NCT05145387 | Active Not Recruiting

• 2 other identifiers: 22-114-1R324A200091
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Excessive anxiety is a common problem that severely impairs short and long term academic functioning. The transition to middle school (MS) results in increases in anxiety and decreases in academic functioning. Students with anxiety in particular, due to their vulnerability to school-based stressors, are at risk for social, emotional and academic failure during the transition to MS. Unfortunately, the majority of these students do not get identified. Reducing student anxiety has been associated with improvement in academic functioning. Because the transition to MS is inevitable, targeting students with excessive anxiety will help their adjustment to their new school setting, reducing the need for special education and mental health counseling. No interventions exist to help these students with this transition. This study aims to: (1) develop and assess the feasibility of a brief, multi-component intervention, referred to as TEAMSS, Transitioning Emotionally and Academically to Middle School Successfully, to reduce anxiety and improve academic functioning through the transition to MS using an iterative development process (i.e., expert review, two open trials, and small randomized controlled trial (RCT)); (2) conduct a pilot RCT comparing the preliminary impact of TEAMSS, relative to enhanced usual care (EUC), in improving students' social, behavioral, and academic functioning through the transition to MS; and (3) examine theory-based mediators, predictors, and moderators of TEAMSS and assess intervention costs.

Conditions

Anxiety Disorders

Keywords

Middle school; Transition; Anxiety

Outcome Measures

Primary Outcomes (2)

• Change in Clinical Global Impression - Severity (CGI-S) Scale

  The CGI-S score provides a global rating of anxiety severity ranging from 1= "not at all ill" to 7= "extremely ill".

  Change from baseline (before intervention) to follow up at 8 months

• Change in Clinical Global Impression - Improvement (CGI-I) Scale

  The CGI-I provides a global rating of clinical improvement in anxiety (relative to baseline) ranging from 1= "very much improved" to 7= "very much worse." Scores of 1-2 are considered "responders."

  Change from post intervention evaluation to follow up at 8 months

Secondary Outcomes (16)

• Change in Screen for Child Anxiety Related Emotional Disorders, Child and Parent Versions (SCARED)

  Change from baseline (before intervention) to follow up at 8 months

• Change in Anxiety Disorders Interview Schedule for DSM-V, Parent and Child Versions (ADIS-V)

  Change from baseline (before intervention) to follow up at 8 months

• Change in Child Anxiety Impact Scale (CAIS)

  Change from baseline (before intervention) to follow up at 8 months

• Change in School Anxiety Scale - Teacher Report (SAS)

  Change from baseline (before intervention) to follow up at 8 months

• Change in School Records

  Change from baseline (before intervention) to follow up at 8 months

Other Outcomes (2)

• Change in TEAMSS Intervention Satisfaction Questionnaire

  Change from post intervention evaluation to follow up at 8 months

• Change in The Child and Adolescent Services Assessment (CASA)

  Change from baseline (before intervention) to follow up at 8 months

Study Arms (2)

TEAMSS Intervention in the RCT

EXPERIMENTAL

Students randomly assigned to the TEAMSS intervention will receive the 5th and 6th grade components.

Behavioral: Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)

Enhanced Usual Care in the RCT

NO INTERVENTION

Enhanced Usual Care (EUC) will serve as the comparison group. EUC will be comprised of written materials (given all at once after randomization by study team) for parents and children that include: 1) a specialty mental health referral list; 2) a list of websites and books on child anxiety; and 3) tip sheets on successful transitions to MS. Families in this condition will not be prohibited from seeking treatment (though this will be monitored) for their children. These students will visit and meet with the 6th grade clinician in the spring of 5th grade.

Interventions

Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS) BEHAVIORAL

Students randomized to TEAMSS will receive reading materials on transitioning to middle school and a a school tour with the middle school clinician (in 5th grade) and the TEAMSS group sessions (in 6th grade) delivered over 10 weeks. During the 10 weeks of TEAMSS, parents of students will attend two group meetings and clinicians will consult with at least one teacher (usually the advisory/homeroom teacher).

TEAMSS Intervention in the RCT

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• be in the last year of a participating elementary school
• have elevated anxiety symptoms that are their primary concern as indicated by 1) a total SCARED score at baseline of 15 or higher using parent and/or child report, and/or 2) a Clinician Severity Rating (CSR) of 3 or higher on the ADIS
• read and understand English (both parent and child).

You may not qualify if:

• Students who have a non-anxiety primary mental health concern (e.g., ADHD) will be excluded from TEAMSS, as this intervention is aimed at reducing anxiety and it would not be effective at treating other mental health concerns. Students with comorbid conditions secondary to anxiety will be eligible.
• Clinician:
• All clinician participants must be at least a part time employee of a CT MS in the role of school clinician.
• None

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

UConn Health

West Hartford, Connecticut, 06119, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Golda Ginsburg, PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: independent evaluators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: RCT

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 6, 2021
• Study Start: February 8, 2024
• Primary Completion: August 30, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)