TEAMSS Program for Anxiety Disorders

(TEAMSS Trial)

Overseen By Golda Ginsburg, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: UConn Health

Disqualifiers: ADHD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

32 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the TEAMSS treatment for anxiety disorders?

Research shows that cognitive-behavioral therapy (CBT), a key component of the TEAMSS program, is effective in reducing anxiety symptoms in school settings. For example, a study found that 95% of children receiving school-based CBT showed improvement in anxiety compared to only 16.7% in a waitlist group. ^{1 2 3 4 5}

Is the TEAMSS Program for Anxiety Disorders safe for humans?

The available research does not provide specific safety data for the TEAMSS Program, but similar school-based interventions for anxiety disorders have been implemented without reported safety concerns, suggesting they are generally safe for participants. ^{1 5 6 7 8}

How is the TEAMSS treatment for anxiety disorders unique compared to other treatments?

The TEAMSS treatment is unique because it specifically targets the transition to middle school, addressing both emotional and academic challenges that can influence anxiety levels during this critical period. Unlike other treatments, it focuses on the contextual stressors and support systems relevant to this transition, which can significantly impact anxiety trajectories in youth. ^{9 10 11 12 13}

What is the purpose of this trial?

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.

Research Team

Golda Ginsburg, PhD

Principal Investigator

UConn Health

Eligibility Criteria

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.

Inclusion Criteria

Student must have elevated anxiety symptoms as their primary concern indicated by a total SCARED score at baseline of 15 or higher using parent and/or child report, and/or a Clinician Severity Rating (CSR) of 3 or higher on the ADIS

I am in my final year at a participating elementary school.

Student must be able to read and understand English (both parent and child)

Exclusion Criteria

Not applicable.

Students with a non-anxiety primary mental health concern (e.g., ADHD) will be excluded from TEAMSS

Clinicians must be at least a part-time employee of a CT MS in the role of school clinician

Timeline

Recruitment, Screening, Baseline Evaluation and Randomization

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention and Monitoring

Eligible students are randomized to TEAMSS or Enhanced Usual Care. TEAMSS group sessions are delivered over 10 weeks.

10 weeks

Weekly group sessions

Post- and Follow-up Evaluations

Participants complete post-intervention evaluation and follow-up evaluation to assess the durability of the intervention.

8 months

2 visits (in-person)

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

Group I: TEAMSS Intervention in the RCT Experimental Treatment 1 Intervention

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

Group II: Enhanced Usual Care in the RCT Active Control 1 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.

Who Is Running the Clinical Trial?

UConn Health

Lead Sponsor

Trials

218

Recruited

59,100+

Findings from Research

The Skills for Academic and Social Success (SASS) program is a school-based cognitive-behavioral intervention designed for adolescents with social anxiety disorder, consisting of 12 group sessions and individual meetings, along with weekend social events.

Initial findings suggest that SASS effectively addresses social anxiety in adolescents by combining social skills training with real-life exposure, while also involving parents and teachers to create a supportive environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skills for social and academic success: a school-based intervention for social anxiety disorder in adolescents. Fisher, PH., Masia-Warner, C., Klein, RG.[2019]

A modular cognitive-behavioral therapy (CBT) program delivered in two elementary schools was highly effective, with 95% of children receiving CBT showing improvement in anxiety symptoms compared to only 16.7% in the waitlist group.

The study indicates that CBT can be successfully implemented in real-world school settings for children aged 5-12 with anxiety disorders, but further research with a larger sample is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of modular CBT for child anxiety in elementary schools. Chiu, AW., Langer, DA., McLeod, BD., et al.[2021]

In a study involving 12 African-American adolescents with anxiety disorders, those receiving cognitive-behavioral treatment (CBT) showed a significant improvement, with 75% no longer meeting diagnostic criteria for their anxiety, compared to only 20% in the control group.

The study demonstrated that CBT was effective in reducing overall anxiety and impairment, and the results suggest that this treatment can be feasibly implemented in urban school settings, benefiting diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based treatment for anxious african-american adolescents: a controlled pilot study. Ginsburg, GS., Drake, KL.[2022]

Cognitive Behavioral Treatment (CBT) showed slightly better improvements in parent-reported child anxiety compared to Treatment as Usual (TAU) at post-treatment, with 42% of CBT participants responding positively versus 37% in TAU.

Overall, both CBT and TAU were similarly effective in reducing anxiety and improving functioning in children with anxiety disorders, with no significant differences at the 1-year follow-up, suggesting that both approaches can be viable options in school settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-Based Treatment for Anxiety Research Study (STARS): a Randomized Controlled Effectiveness Trial. Ginsburg, GS., Pella, JE., Pikulski, PJ., et al.[2021]

A 14-session school-based behavioral treatment program for six adolescents with social anxiety disorder showed that all participants improved, with half no longer meeting the criteria for social phobia after treatment.

Significant reductions in clinician-rated anxiety severity were observed, with effect sizes of 2.5 and 1.8, indicating that school-based interventions can be effective in reducing social anxiety symptoms in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based behavioral treatment for social anxiety disorder in adolescents: results of a pilot study. Masia, CL., Klein, RG., Storch, EA., et al.[2007]

The study will evaluate the effectiveness of the Modular Approach to Therapy for Children (MATCH) in improving mental health and academic outcomes for 168 youths aged 7-14 with symptoms of anxiety, depression, trauma, or conduct problems, compared to usual care.

This randomized controlled trial aims to determine if improvements in mental health from MATCH lead to better school-related outcomes, highlighting the potential of school-based mental health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a Modular Approach to Therapy for Children With Anxiety, Depression, Trauma, or Conduct Problems (MATCH) in School-Based Mental Health Care: Study Protocol for a Randomized Controlled Trial. Harmon, SL., Price, MA., Corteselli, KA., et al.[2021]

Adolescents with anxiety-based school attendance problems showed significant improvement after participating in the Sulman Program, with 17 out of 24 completing a year-long course and reporting better social skills and emotional literacy.

The program's effectiveness is supported by positive changes in personal and social functioning as measured by various scales, along with high parental satisfaction, highlighting the need for flexible educational and mental health support for these adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of patients attending a specialist educational and mental health service for social anxiety disorders. Mcshane, G., Bazzano, C., Walter, G., et al.[2018]

The RISK group CBT program, involving 90 adolescents with anxiety disorders, demonstrated comparable effectiveness to previous benchmarks immediately after treatment and showed significant improvement at a 12-month follow-up, with 79.5% of participants in remission.

The program's success is attributed to its high exposure practice, family and school involvement, and community-based delivery, suggesting it may enhance long-term treatment outcomes for adolescents with anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benchmarked effectiveness of family and school involvement in group exposure therapy for adolescent anxiety disorder. Bertelsen, TB., Wergeland, GJ., Nordgreen, T., et al.[2022]

The study followed 631 youth over 7 years and found that the transition to middle school can significantly impact anxiety levels, with some students experiencing increasing anxiety while others showed decreasing anxiety.

Youth with increasing anxiety reported more contextual stressors, such as peer victimization and poor parent-child relationships, while those with decreasing anxiety had better support systems, highlighting the importance of social context during this transition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual differences in anxiety trajectories from Grades 2 to 8: Impact of the middle school transition. Nelemans, SA., Hale, WW., Branje, SJT., et al.[2022]

School-based interventions for children and adolescents with anxiety show a small but significant reduction in anxiety symptoms, with an effect size of -0.28 immediately after the intervention and maintained effects at 6 months (-0.35) and 12 months (-0.24).

Despite the positive outcomes, the variability between studies was high, indicating that more research is needed to understand the long-term effectiveness and to standardize intervention approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indicated prevention interventions for anxiety in children and adolescents: a review and meta-analysis of school-based programs. Hugh-Jones, S., Beckett, S., Tumelty, E., et al.[2021]

The pilot study involving 225 participants from three schools in Australia found that an online anxiety prevention program was acceptable and feasible to implement in a school setting.

While the program did not show significant reductions in anxiety symptoms compared to a control group, some effect sizes were consistent with previous research, suggesting that further investigation in larger trials is warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of the e-couch anxiety and worry program in schools. Calear, AL., Christensen, H., Brewer, J., et al.[2020]

A systematic review of 27 trials found that school-based prevention and early intervention programs effectively reduce anxiety symptoms in children and adolescents, with effect sizes ranging from 0.11 to 1.37.

Most effective programs targeted adolescents and utilized cognitive behavioral therapy (CBT), highlighting the importance of this approach in managing anxiety in school settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and effectiveness of school-based prevention and early intervention programs for anxiety. Neil, AL., Christensen, H.[2022]

A systematic review identified eight studies of internet-based programs for treating anxiety and depression in children and adolescents, with most interventions based on cognitive behavior therapy.

Six out of eight studies reported reductions in symptoms of anxiety and/or depression after the interventions, indicating early support for the effectiveness of these online programs, although more rigorous research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of internet-based prevention and treatment programs for anxiety and depression in children and adolescents. Calear, AL., Christensen, H.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Skills for social and academic success: a school-based intervention for social anxiety disorder in adolescents. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of modular CBT for child anxiety in elementary schools. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

School-based treatment for anxious african-american adolescents: a controlled pilot study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

School-Based Treatment for Anxiety Research Study (STARS): a Randomized Controlled Effectiveness Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

School-based behavioral treatment for social anxiety disorder in adolescents: results of a pilot study. [2007]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluating a Modular Approach to Therapy for Children With Anxiety, Depression, Trauma, or Conduct Problems (MATCH) in School-Based Mental Health Care: Study Protocol for a Randomized Controlled Trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Outcome of patients attending a specialist educational and mental health service for social anxiety disorders. [2018]

8. Ireland pubmed.ncbi.nlm.nih.gov

Benchmarked effectiveness of family and school involvement in group exposure therapy for adolescent anxiety disorder. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Individual differences in anxiety trajectories from Grades 2 to 8: Impact of the middle school transition. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Indicated prevention interventions for anxiety in children and adolescents: a review and meta-analysis of school-based programs. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A pilot randomized controlled trial of the e-couch anxiety and worry program in schools. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Efficacy and effectiveness of school-based prevention and early intervention programs for anxiety. [2022]

13. Australia pubmed.ncbi.nlm.nih.gov

Review of internet-based prevention and treatment programs for anxiety and depression in children and adolescents. [2022]