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TEAMSS Program for Anxiety Disorders (TEAMSS Trial)
N/A
Recruiting
Led By Golda Ginsburg, PhD
Research Sponsored by UConn Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline (before intervention) to follow up at 8 months
Awards & highlights
Summary
This trial aims to develop and test a program called TEAMSS to help students with anxiety transition successfully to middle school. The program will focus on reducing anxiety and improving academic performance. The study will involve expert
Who is the study for?
The TEAMSS trial is for students in their last year of elementary school who have high anxiety, as shown by specific test scores. Both the child and parent must understand English. It's not specified who can't join, but typically those with other major issues or conditions might be excluded.
What is being tested?
TEAMSS aims to help anxious kids adjust to middle school better, potentially reducing the need for special education and counseling. The study will compare TEAMSS intervention with usual care to see if it improves social, behavioral, and academic outcomes.
What are the potential side effects?
Since this is a psychological/educational intervention rather than a drug treatment, traditional side effects are not expected. However, participants may experience varying levels of stress or discomfort during the transition period.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline (before intervention) to follow up at 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (before intervention) to follow up at 8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Clinical Global Impression - Improvement (CGI-I) Scale
Change in Clinical Global Impression - Severity (CGI-S) Scale
Secondary outcome measures
Change in Academic Competence Evaluation Scale (ACES)
Change in Anxiety Disorders Interview Schedule for DSM-V, Parent and Child Versions (ADIS-V)
Change in Avoidance Hierarchy
+13 moreOther outcome measures
Change in TEAMSS Intervention Satisfaction Questionnaire
Change in The Child and Adolescent Services Assessment (CASA)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TEAMSS Intervention in the RCTExperimental Treatment1 Intervention
Students randomly assigned to the TEAMSS intervention will receive the 5th and 6th grade components.
Group II: Enhanced Usual Care in the RCTActive Control1 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.
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Who is running the clinical trial?
UConn HealthLead Sponsor
212 Previous Clinical Trials
60,747 Total Patients Enrolled
5 Trials studying Anxiety Disorders
628 Patients Enrolled for Anxiety Disorders
Golda Ginsburg, PhDPrincipal InvestigatorUConn Health
2 Previous Clinical Trials
85 Total Patients Enrolled
1 Trials studying Anxiety Disorders
40 Patients Enrolled for Anxiety Disorders
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