Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)

NCT ID: NCT05145387

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-08
• Study Completion Date: 2026-07-30

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.

Detailed Description

The pilot RCT will be conducted with approximately 8 school-based clinicians from 6-8 middles schools (MS). Approximately 42 5th grade students from 12 elementary schools with elevated anxiety will be recruited. The RCT will be conducted in 3 phases:

Phase 1 - Recruitment, Screening, Baseline Evaluation and Randomization: In Phase 1, 5th grade students will be referred to study staff for screening and evaluation from 5th grade teachers, clinicians and parents and self-referrals. Interested parents and students will contact study staff and complete a brief phone screen. Families who pass the screen will complete informed consent and the full baseline evaluation (consisting of a diagnostic interview and questionnaires) with an Independent Evaluator.

Phase 2 - Intervention and Monitoring: Eligible students will be randomized (1:1) to TEAMSS (n = 21) or Enhanced Usual Care (EUC; n= 21). Students in both groups will receive the 5th grade components but only students randomized to TEAMSS will receive 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 MS teacher.

Phase 3 - Post- and Follow-up Evaluations: At the end of the 10-week intervention/EUC phase, students in both groups will complete the post-intervention (3 months into transition year i.e., December). Five months after the intervention ends (8 months into the transition year i.e., May), students in both groups will complete a follow up evaluation to assess the durability of the intervention. A seventh group with students, and a third group for parents, occurring approximately four weeks after session 6 will be conducted to debrief (discuss their experience in the program), ask them about any lingering questions or concerns related to anxiety, and update them on what was learned.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TEAMSS Intervention in the RCT

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

Group Type: EXPERIMENTAL

Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)

Intervention Type: 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).

Enhanced Usual Care in the RCT

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

• All clinician participants must be at least a part time employee of a CT MS in the role of school clinician.

Exclusion Criteria

• 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:

• None

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Golda S. Ginsburg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Golda Ginsburg, PhD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

UConn Health

West Hartford, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R324A200091

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

22-114-1

Identifier Type: -

Identifier Source: org_study_id