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临床试验/NCT04097496
NCT04097496终止不适用

Multi-Site Cluster, Randomized Proof of Concept Trial to Study the Effects of the ACT OUT! Social Issue Theater Program on Social-Emotional Competence and Bullying in Youth and Adolescents

Indiana University2 个研究点 分布在 1 个国家目标入组 1,537 人开始时间: 2019年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1,537
试验地点
2
主要终点
Change from Baseline Social-Emotional Competence

研究概览

简要总结

The ACT OUT! Trial is designed as a proof-of-concept, cluster, randomized, superiority trial with two parallel groups. Although the unit of measurement is student, the unit of randomization is classroom, stratified by school. For each grade, an even number of classrooms will be selected from each school; half of the selected classrooms will be randomly assigned to intervention arm, whereas the other half will be assigned to control arm. This way, sociodemographic and school-level factors will be made approximately comparable between intervention and control arms.

详细描述

This study will be an assessment of the ACT OUT! Social Issue Theater program as a universal social and emotional learning (SEL) intervention targeting social-emotional competence (SEC) and bullying in elementary, middle, and high school students. ACT OUT! is an existing program that has been performed in various forms by professionally-trained members of an acting ensemble since 1995. The present iteration consists of three distinct scenarios per grade range (elementary, middle, and high) that present age-appropriate improvisational drama illustrating issues related to SEL and bullying, including facilitated discussion with the actors, who remain in character. The program lasts approximately one hour (scenario descriptions and a fidelity checklist for SEL/bullying elements will be made available as supplemental files).

SEL curricula typically consist of manualized and/or structured classroom or multicomponent programs taking place over time; the median number of sessions within an SEL program in a meta-analysis of 213 SEL studies was 24. At one hour in duration, ACT OUT! is substantially shorter and is performed by professional actors - meeting the goal of reduced school resource costs for SEL programming, but potentially raising concerns about whether such a dose could reasonably be expected to produce an effect. Underlying this study is a supposition that unique properties of a dramatic performance specifically may trigger SEL responses. In Aristotle's Poetics, which is the first known work on dramatic theory, it is written that a dramatic tragedy (in the Aristotelian sense) is designed to arouse certain feelings, "wherewith to accomplish catharsis of... emotions." This precise mechanism underlies the development of psychodrama as a psychotherapeutic intervention, as combined action and verbalization can present a situation "freed from the restricting stereotyped residues of past experience." Recent studies and meta-analyses have examined psychodrama as a means of prevention and/or behavior change with generally positive findings. Researchers have also found that youth report that they enjoy psychodramatic elements as part of a larger prevention curriculum. However, no studies have measured any outcomes of a psychodramatic SEL experience.

This will be the first study to examine whether a short dose of interactive psychodrama can affect SEC metrics and bullying experiences in schoolchildren. In responding to recent criticism of SEL studies, the investigators have chosen to utilize the SPIRIT 2013 clinical trial guidelines in developing this protocol to promote rigor, reproducibility, and transparency.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Because of the nature of the ACT OUT! trial, blinding of the trial participants, school officials, and members of Claude McNeal Productions is not possible. Further, since data management will occur via the primary research team, group identity cannot realistically be masked. However, we have included two statistical consultants - one internal to the university and one external to the university - who will be asked to verify all analyses using masked group assignment.

入排标准

性别
All
接受健康志愿者

入选标准

  • Classrooms must be comprised of 4th grade (Elementary), 7th grade (Middle), or 10th grade (High) students

排除标准

  • Participants and their parents or legal guardians will review study procedures. Parents or guardians may opt out on behalf of their dependents, and participants may themselves opt out.
  • If a given grade within a school has an odd number of classrooms, one classroom randomly will be excluded from participation.

结局指标

主要结局

Change from Baseline Social-Emotional Competence

时间窗: Separately, 2 weeks post-intervention, and 3 months post-intervention

Computed from the Delaware Social Emotional Competency Scale (DSECS-S). The score is averaged from Likert-type data (e.g., one overall score will be computed from 12 questions). The score ranges from '1' to '4' - some items will be reverse coded, so that a '4' is consistently the optimal score across questions and for the total scale value.

Change from Baseline Bullying Prevalence (self-report)

时间窗: Separately, 2 weeks post-intervention, and 3 months post-intervention

Bullying activity (being bullied and bullying) via two parallel 13-item scales on the Bullying and Cyberbullying Scale for Adolescents (BCS-A). This scale captures frequency data and so is interpretable on its face (e.g., # instances of a behavior or observation).

Change from Baseline Bullying Prevalence (objective)

时间窗: 3 months post-intervention

Disciplinary referrals for bullying (aggregated, not individual)

次要结局

  • Receptivity to the Act Out! Intervention(2 weeks post-intervention)
  • Frequency of Truancy/Absenteeism(3 months post-intervention)
  • Change from Baseline Social-Emotional Competence Sub-Domains (7th and 10th grades only)(Separately, 2 weeks post-intervention, and 3 months post-intervention)
  • Academic Performance using standard Grade Point Average(3 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jon Agley

Associate Professor

Indiana University

研究点 (2)

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