Anxiety DisordersTEAMSSNCT05145387
Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)
A study testing Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS) in people with Anxiety Disorders, run by UConn Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2024to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transitioning Emotionally and Academically to Middle School Successfully: Development of a Brief Intervention to Reduce Student Anxiety (TEAMSS)
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.
Read the 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
- Being tested
- Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)
- Keywords
- Middle school, Transition, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| TEAMSS Intervention in the RCT | Experimental | Students randomly assigned to the TEAMSS intervention will receive the 5th and 6th grade components. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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."
Measured: 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)
A widely used 41 item measure of childhood anxiety. Informants respond to items using a 3-point Likert-type scale (0 = "not true or hardly ever true", 1 = "somewhat true or sometimes true", 2 = "very true or often true").
Measured: 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)
Considered the gold standard for assessing anxiety diagnosis and severity. Impairment ratings are generated for each disorder using the Clinician Severity Rating (CSR, range = 0-8; 4 or higher is required to assign a diagnosis).
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in Child Anxiety Impact Scale (CAIS)
A 27 item measure of anxiety-related interference in social, academic and family functioning. It is scored on a 4-point Likert scale, from 0= "not at all" to 3= "very much."
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in School Anxiety Scale - Teacher Report (SAS)
The SAS is a 16 item questionnaire of student anxiety, items are rated on a 3 point scale (0 = "never" to 3 = "always").
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in School Records
Assess grades, attendance, referrals for special education, grade retention and referrals for disciplinary actions (e.g., suspensions, detentions).
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in Academic Competence Evaluation Scale (ACES)
A 50 item questionnaire, scored on a 5-point Likert scale ranging from "never" to "almost always" that assesses: Academic Skills (reading, mathematics, critical thinking) and Academic Enablers (Motivation, Engagement, Study Skills, Interpersonal Skills).
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in Subtests from the Woodcock-Johnson IV Tests of Achievement and Cognitive Abilities (WJ IV)
These subtests are a widely used, norm-referenced measure of academic achievement and cognitive abilities. Reading, math fluency and numbers reversed will be administered to measure cognitive factors (e.g., efficiency, speed, working memory) that are affected by anxiety.
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in Children's Automatic Thoughts Scale (CATS)
A 40 item questionnaire of maladaptive thoughts associated with anxiety. Items are scored on a 5-point Likert scale from 0= "not at all" to 4= "all the time." To reduce burden, only the Physical and Social Threat subscale will be used.
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in Avoidance Hierarchy
A 3 item measure used in our ongoing studies, which assesses how frequently the student avoids specific anxiety provoking situations from 1 = "never" to 7 = "every time."
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in Children's Somatization Inventory (CSI-24)
A 24 item measure of the child's somatic symptoms (headaches, stomach aches). Items are ranked using a 5 point scale ranging from "not at all" to "a whole lot."
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in My Memories of Growing Up (Egna Minnen Beträffande Uppfostran; EMBU)
A 40 item measure of parental over control and anxious rearing practices associated with higher anxiety. This scale consists of four subscales with 10 items each: overprotection/control, emotional warmth, rejection, and anxious rearing. For purposes of this study, only the overprotection/control and anxious rearing subscales will be used. Items are answered on a 4-point Likert scale ranging from 1= "no," to 4= "yes, most of the time."
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in Family Accommodation Scale - Anxiety (FASA)
A measure of accommodation. Parents respond to 9 items, which are coded on a 5-point Likert scale from 0 = "never" to 4 = "daily."
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in Children's Organizational Skills Scale (COSS)
A 41 item parent, teacher and child measure of organization, planning and time-management. The COSS yields three subscale scores: task planning, organized actions and memory and materials management.
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in Children's Global Assessment Scale (CGA-S)
A measure to assess the student's overall improvement, as a result of participating in the intervention.
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in Strength and Difficulties Questionnaire Parent Version (SDQ
A widely used and psychometrically sound (alpha = .80) 25 item parent report questionnaire that assesses emotional and behavioral difficulties in children 4-17 years old. It yields a total score and five subscale scores: emotion problems, conduct problems, hyperactivity, peer problems and prosocial.
Measured: Change from baseline (before intervention) to follow up at 8 months
Change in Revised Child Anxiety and Depression Scale - Depression subscale only (RCADS)
The RCADS Depression subscale is comprised of 10 items. Youth respond to items using a 4-point Likert-type scale (0-3) to indicate the frequency of symptoms: 'never,' 'sometimes,' 'often,' and 'always.' Higher scores reflect greater frequency of depressive symptoms.
Measured: Change from baseline (before intervention) to follow up at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start8 Feb 2024
- Primary completion30 Aug 2025
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Golda S. Ginsburg, UConn Health
- Investigators
- Golda Ginsburg, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145387
- Sponsor's protocol ID
- 22-114-1
- Other IDs
- R324A200091
- Acronym
- TEAMSS
- Status last verified
- Jun 2026
- First submitted
- 5 Nov 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitioning Emotionally and Academically to Middle School Successfully: Development of a Brief Intervention to Reduce Student Anxiety (TEAMSS)
- ClinicalTrials.gov ID
- NCT05145387
- Acronym / sponsor ID
- TEAMSS / 22-114-1
- Conditions
- Anxiety Disorders
- Keywords
- Middle school, Transition, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| TEAMSS Intervention in the RCT | Experimental | Behavioral: Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)Students randomly assigned to the TEAMSS intervention will receive the 5th and 6th grade components. |
| 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. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | TEAMSS Intervention in the RCT |
Primary outcome
Change in Clinical Global Impression - Severity (CGI-S) Scale
Time frame: Change from baseline (before intervention) to follow up at 8 months
The CGI-S score provides a global rating of anxiety severity ranging from 1= "not at all ill" to 7= "extremely ill".
Change in Clinical Global Impression - Improvement (CGI-I) Scale
Time frame: Change from post intervention evaluation to follow up at 8 months
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."
16 secondary outcomes
Change in Screen for Child Anxiety Related Emotional Disorders, Child and Parent Versions (SCARED)
Time frame: 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)
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in Child Anxiety Impact Scale (CAIS)
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in School Anxiety Scale - Teacher Report (SAS)
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in School Records
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in Academic Competence Evaluation Scale (ACES)
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in Subtests from the Woodcock-Johnson IV Tests of Achievement and Cognitive Abilities (WJ IV)
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in Children's Automatic Thoughts Scale (CATS)
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in Avoidance Hierarchy
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in Children's Somatization Inventory (CSI-24)
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in My Memories of Growing Up (Egna Minnen Beträffande Uppfostran; EMBU)
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in Family Accommodation Scale - Anxiety (FASA)
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in Children's Organizational Skills Scale (COSS)
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in Children's Global Assessment Scale (CGA-S)
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in Strength and Difficulties Questionnaire Parent Version (SDQ
Time frame: Change from baseline (before intervention) to follow up at 8 months
Change in Revised Child Anxiety and Depression Scale - Depression subscale only (RCADS)
Time frame: Change from baseline (before intervention) to follow up at 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Golda Ginsburg, PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS) in people with Anxiety Disorders, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Global Impression - Severity (CGI-S) Scale (time frame: Change from baseline (before intervention) to follow up at 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.