Transitioning Emotionally and Academically to Middle School Successfully: Development of a Brief Intervention to Reduce Student Anxiety (TEAMSS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in Clinical Global Impression - Improvement (CGI-I) Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
independent evaluators
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
- •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:
研究组 & 干预措施
TEAMSS Intervention in the RCT
Students randomly assigned to the TEAMSS intervention will receive the 5th and 6th grade components.
干预措施: Transitioning Emotionally and Academically to Middle School Successfully (TEAMSS) (Behavioral)
Enhanced Usual Care in the RCT
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.
结局指标
主要结局
Change in Clinical Global Impression - Improvement (CGI-I) Scale
时间窗: 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."
Change in Clinical Global Impression - Severity (CGI-S) Scale
时间窗: 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".
次要结局
- Change in Academic Competence Evaluation Scale (ACES)(Change from baseline (before intervention) to follow up at 8 months)
- Change in Avoidance Hierarchy(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)(Change from baseline (before intervention) to follow up at 8 months)
- Change in Child Anxiety Impact Scale (CAIS)(Change from baseline (before intervention) to follow up at 8 months)
- Change in School Anxiety Scale - Teacher Report (SAS)(Change from baseline (before intervention) to follow up at 8 months)
- Change in School Records(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)(Change from baseline (before intervention) to follow up at 8 months)
- Change in Strength and Difficulties Questionnaire Parent Version (SDQ(Change from baseline (before intervention) to follow up at 8 months)
- Change in Screen for Child Anxiety Related Emotional Disorders, Child and Parent Versions (SCARED)(Change from baseline (before intervention) to follow up at 8 months)
- Change in Children's Somatization Inventory (CSI-24)(Change from baseline (before intervention) to follow up at 8 months)
- Change in My Memories of Growing Up (Egna Minnen Beträffande Uppfostran; EMBU)(Change from baseline (before intervention) to follow up at 8 months)
- Change in Family Accommodation Scale - Anxiety (FASA)(Change from baseline (before intervention) to follow up at 8 months)
- Change in Children's Global Assessment Scale (CGA-S)(Change from baseline (before intervention) to follow up at 8 months)
- Change in Revised Child Anxiety and Depression Scale - Depression subscale only (RCADS)(Change from baseline (before intervention) to follow up at 8 months)
- Change in Children's Automatic Thoughts Scale (CATS)(Change from baseline (before intervention) to follow up at 8 months)
- Change in Children's Organizational Skills Scale (COSS)(Change from baseline (before intervention) to follow up at 8 months)
研究者
Golda S. Ginsburg
Professor
UConn Health