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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help students manage anxiety as they transition to middle school, focusing on improving emotional well-being and academic performance. It tests a new approach called TEAMSS (Transitioning Emotionally and Academically to Middle School Successfully) and compares it to the usual care of providing informational resources. Students in their last year of elementary school who experience significant anxiety affecting their daily life might be suitable candidates for this trial. The goal is to determine if TEAMSS can ease the transition to middle school and reduce the need for extra support. As an unphased trial, this study provides a unique opportunity for students to benefit from innovative support strategies during a crucial transition period.

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 prior data suggests that the TEAMSS program is safe for students transitioning to middle school?

Research shows that the TEAMSS program, designed to help students adjust to middle school, is well-received. Earlier studies found that children in similar school-based programs for anxiety experienced much lower anxiety levels than those who did not participate. These studies reported no major safety issues, indicating the program's safety for children.

Although specific details about side effects for the TEAMSS program aren't provided, experts have carefully developed and reviewed it through trials to ensure safety and effectiveness. The program aims to reduce anxiety, which can enhance school performance and social skills during the transition to middle school. Overall, the TEAMSS program focuses on student safety while achieving positive outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TEAMSS program for anxiety disorders because it offers a comprehensive approach to helping students transition to middle school, addressing both emotional and academic challenges. Unlike traditional treatments for anxiety that may involve medication or individual therapy sessions, TEAMSS provides a structured intervention that incorporates components for both 5th and 6th graders, potentially offering more tailored support during this critical transition period. Additionally, the TEAMSS program involves parental engagement through written materials, mental health resources, and strategies for successful school transitions, which can create a supportive environment beyond the clinical setting. By enhancing usual care with these elements, researchers hope to better support students during a pivotal time in their development.

What evidence suggests that the TEAMSS program is effective for reducing anxiety during the transition to middle school?

Research has shown that moving to middle school can increase anxiety and affect grades for many students. Few proven methods exist to ease this transition. This trial tests the TEAMSS program as an intervention, employing various strategies to reduce anxiety. Early results indicated that parents observed fewer anxiety-related behaviors. However, the first trials showed no improvements in academic or social skills. This program might help students manage anxiety better during this challenging transition. Participants in the trial will either receive the TEAMSS intervention or join the Enhanced Usual Care group for comparison. ^{1 2 4 6 7}

Who Is on the Research Team?

Golda Ginsburg, PhD

Principal Investigator

UConn Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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 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]

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]

Citations

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Feasibility, Fidelity, Satisfaction, and Preliminary Outcomes ... The transition from elementary to middle school is associated with increases in anxiety and related impairment, yet few evidence-based interventions exist ...

2. researchgate.net researchgate.net/publication/391574553_Feasibility_Fidelity_Satisfaction_and_Preliminary_Open_Trial_Student_Outcomes_of_a_Brief_School-Based_Intervention_to_Reduce_Student_Anxiety_During_the_Transition_to_Middle_School

Feasibility, Fidelity, Satisfaction, and Preliminary Open Trial ... Parents reported reducing maladaptive accommodation of anxiety; no improvements in academic organizational or social skills were observed.

3. withpower.com withpower.com/trial/phase-anxiety-disorders-11-2021-19c16

TEAMSS Program for Anxiety Disorders · Info for Participants The transition to middle school (MS) results in increases in anxiety and decreases in academic functioning. Students with anxiety in particular, due to their ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK589826/

Evidence reviews for interventions to support children ... - NCBI The quantitative data was broadly mixed across all outcomes for school transition interventions. Effectiveness of interventions showed significant differences ...

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2018.01482/full

A Review of the Academic and Psychological Impact ... A longitudinal study of U.S. schoolchildren aged 11–13, showed a decrease in anxiety symptoms following the move to secondary education (Grills-Taquechel et al.

6. researchgate.net researchgate.net/publication/361811342_Children's_anxiety_academic_self-efficacy_and_intergenerational_transmission_of_worries_regarding_the_transition_to_middle_school

Children's anxiety, academic self‐efficacy, and ... Results The results show that children's anxiety is positively related to their worries about the transition to middle school, whereas children's academic self ...

7. researchgate.net researchgate.net/publication/7589009_Early_Intervention_for_Childhood_Anxiety_in_a_School_Setting_Outcomes_for_an_Economically_Disadvantaged_Population

Early Intervention for Childhood Anxiety in a School Setting Children assigned to active intervention demonstrated a significant reduction in symptoms of anxiety relative to children assigned to waitlist ...