Effects of ACT OUT! Social Issue Theater on Youth and Adolescents

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Bullying, Social Competence

Intervention / Treatment
-----------------
* Behavioral: Act Out! Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Classrooms must be comprised of 4th grade (Elementary), 7th grade (Middle), or 10th grade (High) students Exclusion Criteria: 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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The ACT OUT! Trial is designed as a proof-of-concept, cluster, randomized, superiority trial with two parallel groups. Randomization will be performed within clusters with a 1:1 allocation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Act Out! Intervention<br>Eligible classrooms will be randomized to attend a 1-hour ACT OUT! interactive, semi-improvisational psychodrama performance. The ACT OUT! intervention is an established theater program (https://www.claudemcnealproductions.com/act-out-ensemble/). The ACT OUT! production will include three to five vignettes paired with moderated discussions between the audience and the actors, the latter who will remain partly in character for the duration of the intervention. Vignettes will be different for each grade level included in the study (4th, 7th, and 10th). Public documentation of the guidelines for the ACT OUT! intervention will be made available as a supplemental file attached to the primary outcomes paper for the study. | Behavioral: Act Out! Intervention<br>* Data included in the description of the intervention arm.<br>|
| No Intervention: Control<br>Classrooms randomized to this arm will continue with their school day as normal, except that they will complete the data collection tools. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Social-Emotional Competence | 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. | Separately, 2 weeks post-intervention, and 3 months post-intervention | 
| Change from Baseline Bullying Prevalence (self-report) | 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). | Separately, 2 weeks post-intervention, and 3 months post-intervention | 
| Change from Baseline Bullying Prevalence (objective) | Disciplinary referrals for bullying (aggregated, not individual) | 3 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Social-Emotional Competence Sub-Domains (7th and 10th grades only) | Social awareness, emotion regulation, relationship skills, and responsible decision-making as measured via 4 sub-scales of the Washoe County School District Social-Emotional Competency Assessment. For each sub-scale, the score is averaged from Likert-type data (e.g., one overall score will be computed from 3-5 questions). The score ranges from '1' to '4' - a '4' is consistently the optimal score across questions and for the total scale value. | Separately, 2 weeks post-intervention, and 3 months post-intervention | 
| Receptivity to the Act Out! Intervention | Subjective receptivity to the intervention (e.g., enjoyment) as measured by response items from Dent et al. (1998). This scale *does not* have a specific name. It measures the following characteristics of receptivity to the intervention: whether it was enjoyable, interesting, a waste of time, boring, understandable, difficult to understand, believable, important, and helpful. Each item is measured using a Likert-type scale. 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. | 2 weeks post-intervention | 
| Frequency of Truancy/Absenteeism | Data for clusters from district records (aggregated, not individual). These data already exist. No individual-level data will be utilized, only aggregated frequency of truancy/absenteeism. | 3 months post-intervention | 
| Academic Performance using standard Grade Point Average | Data for clusters from district records (aggregated, not individual); grade point average normalized to a 4.0 grading scale (where 4.0 is an A and 1.0 is an F). | 3 months post-intervention |