Clinical trial NCT05145387: Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS)
Official title: Transitioning Emotionally and Academically to Middle School Successfully: Development of a Brief Intervention to Reduce Student Anxiety (TEAMSS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Keywords: Middle school
Transition
Anxiety
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 32
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

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.

Eligibility criteria: Student:

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).

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:

Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Clinical Global Impression - Severity (CGI-S) Scale
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in Clinical Global Impression - Improvement (CGI-I) Scale
timeFrame: Change from post intervention evaluation to follow up at 8 months
Secondary outcomes:
measure: Change in Screen for Child Anxiety Related Emotional Disorders, Child and Parent Versions (SCARED)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in Anxiety Disorders Interview Schedule for DSM-V, Parent and Child Versions (ADIS-V)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in Child Anxiety Impact Scale (CAIS)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in School Anxiety Scale - Teacher Report (SAS)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in School Records
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in Academic Competence Evaluation Scale (ACES)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in Subtests from the Woodcock-Johnson IV Tests of Achievement and Cognitive Abilities (WJ IV)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in Children's Automatic Thoughts Scale (CATS)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in Avoidance Hierarchy
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in Children's Somatization Inventory (CSI-24)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in My Memories of Growing Up (Egna Minnen Beträffande Uppfostran; EMBU)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in Family Accommodation Scale - Anxiety (FASA)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in Children's Organizational Skills Scale (COSS)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in Children's Global Assessment Scale (CGA-S)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in Strength and Difficulties Questionnaire Parent Version (SDQ
timeFrame: Change from baseline (before intervention) to follow up at 8 months
measure: Change in Revised Child Anxiety and Depression Scale - Depression subscale only (RCADS)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
Other outcomes:
measure: Change in TEAMSS Intervention Satisfaction Questionnaire
timeFrame: Change from post intervention evaluation to follow up at 8 months
measure: Change in The Child and Adolescent Services Assessment (CASA)
timeFrame: Change from baseline (before intervention) to follow up at 8 months
Locations:
city: West Hartford
country: United States
facility: UConn Health
state: Connecticut
Study officials:
affiliation: UConn Health
name: Golda Ginsburg, PhD
role: PRINCIPAL_INVESTIGATOR
References: