In the United States, students typically spend 1224 hours each year at school (6.8 hours per day for 180 days/year) [1], which is a substantial portion of their developmental lives. In this context, the past 25 years have seen renewed calls for the US education system to focus on holistic child development and social and emotional learning (SEL) in addition to standardized academic metrics [2]. SEL is widely considered to be important for improving students’ academic and nonacademic outcomes [3]. The implementation of SEL curricula, and even the core definition of SEL, does vary somewhat [4], and researchers continue to design and test SEL programs and implementation approaches in educational settings, typically using a framework advanced by the Collaborative for Academic, Social, and Emotional Learning (CASEL), which focuses on 5 domains: self-awareness, self-management, social awareness, relationship skills, and responsible decision making [5]. Learning in these domains is expected to foster corresponding social-emotional competence (SEC) [6]. A model from a recent study (Conceptual Model for Advancing SEL in Schools) by Greenberg et al [7] proposed that an overall interaction between SEL and SEC domains and program implementation leads to the improvement of various short-term and long-term outcomes for students. Although individual study results have varied considerably, an examination of 4 meta-analyses of hundreds of SEL studies in the US education system found substantive evidence for short-term benefits across a wide spectrum of outcomes, including targeted SEC outcomes, improved academic performance, reduced problematic conduct frequency, and lower emotional distress. Longer-term outcomes were significant in 2 meta-analyses for academic achievement [8].

Importantly, these positive outcomes appear in some cases to extend to serious school-related behavioral issues, such as bullying. Bullying is relatively ubiquitous in US schools. The prevalence of school bullying reported in a 2014 meta-analysis of 80 studies that included data on youth aged 12-18 years was 35% for traditional bullying and 15% for cyberbullying [9]. Thus, it is notable that several studies have observed an association between SEL programs and/or constructs and the attenuation of bullying or aggressive behavior [10-12], and an inverse relationship exists between perceptions that SEL instruction is being offered and perceptions of bullying at school [13].

Although best practices for SEL education have been proposed and are being refined, there remain many barriers to implementation. These include costs related to training and teachers’ time to learn about and teach SEL curricula, perceived inability to divert instructional time to SEL, potential lack of fidelity due to selective use of manualized elements, and competition with academic testing time [14,15]. For some SEL curricula, teacher time comprises a large fraction of the measured cost [16], although accurate measurement of costs and benefits of a given SEL curriculum is complex and subject to meaningful variability [17]. In addition, some scholars have been critical of the level of rigor of many SEL and SEC studies [18], asserting that the positive findings from meta-analyses may be overestimated or that the speed of SEL program adoption may exceed the generation of knowledge and understanding of how to maintain positive outcomes [19]. The current state of knowledge suggests the continued importance of research into SEL programming, both as an outcome (ie, development of SEC through SEL) and as a mediator of problem behavior (eg, bullying). To advance what is known, SEL research should prioritize methodological rigor and approaches that minimize school resource costs.

This study will be an assessment of the ACT OUT! social issue theater program as a universal SEL intervention targeting 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 [20]. The present iteration consists of 3 distinct 15-min scenarios per grade range (elementary, middle, and high) that present age-appropriate improvisational dramas that illustrate issues related to SEL and bullying, including facilitated discussion between the actors—who remain in character—and the students. The program lasts approximately 1 hour to fit within a typical class period within the school day, including introductions, performance, and engagement.

ACT OUT! may be contrasted with typical SEL curricula. SEL curricula tend to consist of manualized, structured classroom or multicomponent programs involving multiple sessions over time. The median number of sessions within an SEL program in a meta-analysis of 213 SEL studies was 24 [21]. Being 1 hour in duration, ACT OUT! is substantially shorter and is performed by third party, professional actors, thus meeting the goal of reduced school resource costs for SEL programming but potentially raising concerns about if such a relatively brief dose could reasonably be expected to produce an effect. Underlying this study is a supposition that unique properties of a dramatic performance may specifically 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” (as cited in an academic essay by Rosenstein [22] from a translation by Richard McKeon). This precise mechanism underlies the development of psychodrama as a psychotherapeutic intervention, as combined action and verbalization can present a situation that elicits an emotional response “freed from the restricting stereotyped residues of past experience” [23]. Recent studies and meta-analyses have examined psychodrama as a means of prevention and/or behavior change with generally positive findings [24-30]. Researchers have also found that youth are receptive to psychodramatic elements as part of a larger prevention curriculum [31]. However, no published studies have measured any outcomes of a single-session psychodramatic SEL experience.

This will be the first study to examine if a short dose of interactive psychodrama can affect SEC metrics and bullying experiences in schoolchildren in either the short (2 weeks) or medium (6 months) term. To respond to recent criticism of SEL studies, we have chosen to utilize the SPIRIT 2013 clinical trial guidelines in developing this protocol to promote rigor, reproducibility, and transparency [32].

This study was granted approval by the Indiana University institutional review board (IRB; #1908563296).

The ACT OUT! trial is designed as a proof-of-concept cluster randomized superiority trial with 2 parallel groups. Although the unit of measurement is the student, the unit of randomization is the classroom, stratified by school. For each grade (fourth, seventh, and 10th), an even number of classrooms will be selected from each school; half of the selected classrooms will be randomly assigned to the intervention arm and the other half will be assigned to the control arm. If there is an odd number of classrooms for a given grade and school, the excluded classroom will be determined randomly. The use of this approach will better ensure comparable sociodemographic and school-level factors between intervention and control arms. Study hypotheses and objectives are shown in Figure 1. Participant flow, including measurement points, is shown in Figure 2.

The comparator in this study is treatment as usual (TAU), which in this case reflects continued school activity as would have otherwise occurred. This study uses a novel and low-dose intervention in a protocol that would, in a clinical setting, approximate an early phase II stage. As a result, the core questions revolve around if the intervention works at all versus if it is superior to other mechanisms that may impact the same metrics. This is consistent with recent recommendations from an expert panel from the National Institutes of Health [33].

The ACT OUT! trial will be conducted in public and charter schools in Marion County, Indiana, an urban county of 954,670 people who are 54.8% non-Hispanic white, 28.9% African American, and 10.6% Hispanic, with a median household income of US $44,689 [34]. The trial will recruit schools until meeting a threshold of 80 classrooms, 40 randomized to the intervention condition and 40 parallel classrooms randomized to the control condition.

All individuals delivering the psychodrama interventions will be professional actors trained to the standards of Claude McNeal Productions, a professional theater company.

Eligible classrooms will be randomized to attend a 1-hour ACT OUT! interactive, semi-improvisational psychodrama performance or to continue with their school day as normal (TAU). Interventions will be delivered within the standard school day as defined for each classroom and school. The ACT OUT! production will include 3 vignettes paired with moderated discussions between the audience and the actors, and the latter will remain in character for the duration of the intervention. Intervention guidelines will be made available alongside the published study.

Adherence to the ACT OUT! intervention protocol will be measured at each delivery point using a fidelity checklist by a part-time employee of Claude McNeal Productions who is not a member of the acting ensemble. The fidelity checklist will contain scenario-specific items for all potential scenarios and will be made available as a multimedia appendix attached to the primary outcomes paper. Given the nature of improvisational psychodrama, the checklist will identify core areas and themes that must be addressed for the specific intervention to be considered to have been delivered with fidelity to the model. Each content area or procedure will be identified as delivered/complete or undelivered/incomplete, and the ratio will be used to generate a fidelity percentage for each delivery instance. To establish reliability, a second individual from the research team will attend 15% (6/40) of performances and complete fidelity checklists to compute interrater reliability (free-marginal kappa).

The sample size was calculated based on the primary outcome (change in SEC). Notably, there are no extant studies examining the effects of professionally acted interactive psychodrama on SEC outcomes and, hence, no directly applicable effect size estimates. However, several studies have utilized psychodrama/theater as an intervention component for non-SEC outcomes, including health promotion, sexual abuse prevention, HIV prevention, violence prevention, and nutrition education. Those studies found widely varying, significant effect sizes ranging from small to large, and, in cases where effect size calculations were not included, significant improvements in outcome metrics were found. The interventions varied substantially in quality, scope, and relationship with the measured outcomes [24-29]. An earlier Cochrane review covering the years 1990 to 2006 found only 9 studies of inconsistent quality, with generally modest but positive results [30]. Separately, a robust 2012 meta-analysis by Sklad et al [41] related to SEC identified 31 universal school-based programs that addressed social learning with an aggregated Cohen d of 0.70 (SE of d 0.10), a large effect size, but those programs were longer than the ACT OUT! intervention.

On the basis of this information, we have powered this trial to detect a moderate difference in SEC (Cohen d=0.30). For a baseline sample with a parallel superiority trial, with a 2-sided significance of .05, power of 0.80, and location of the mean in 1 group as a percentile of the other group set at 62% (corresponding to Cohen d=0.30), we calculated a need for 340 participants. As this is a cluster trial, we adjusted for similarities within the groups (clustering effect) using previous research on smoking prevention [42] as a conservative metric in the absence of similar data for SEL. This yielded an intracluster correlation (ICC) value of 0.153. The design effect, assuming 20 students per classroom (m), was calculated as [1+(m−1)×ICC], yielding 3.907. The design effect multiplied by the number of participants was 1328, but we also wanted to plan for approximately 20% loss to issues related to matching and attrition. Thus, we calculated a final sample need of 1594 students, constituting an estimated 80 classrooms evenly split into intervention and control arms.

Each school involved in the ACT OUT! trial will be chosen based on its receptiveness and interest in participating in the project. Only schools that have provided a signed letter of agreement from an authorized official will be allowed to participate in the study. This study will utilize a waiver of parental consent (opt out), which was approved as part of the IRB submission. Neither the intervention nor the questionnaire poses more than minimal risk to participants or anyone else secondarily connected with the study (eg, their families and teachers). Surveys will be grouped by classroom and administered in a confidential manner. As part of this protocol, a notification letter and copy of the complete posttest survey instrument will be sent home to parents a minimum of 2 weeks before initial subject interaction (parent letter included as Multimedia Appendix 1). Parents and/or guardians will be able to opt their child out of the study simply by returning the second page of the letter to the school. Students will be provided with a brief summary of the study at the top of each survey form. They will be informed that they may also opt out of the study by simply not completing the instrument or by selectively skipping items based on comfort level.

The practical purpose of using a waiver of parental consent in recruitment is the substantial difference in participation prevalence as well as potential ethical concerns resulting from the probable exclusion of underrepresented minorities and high-risk populations, as in the study by White et al [43]. Indeed, several recent studies have suggested that active parental consent and opt-in methods produce smaller student samples with different characteristics, including some related to this study (such as bullying) [43-45]. These issues mirror similar findings related to sociodemographics, risk behaviors, and study participation reported in the previous several decades of school-based research [46-49]. In general, these studies imply that active parental consent may reduce sample size, introduce bias, and thus limit the generalizability of studies with youth.

Due to the nature of the ACT OUT! trial, blinding of the trial participants, school officials, and members of Claude McNeal Productions is not possible. Furthermore, as data management will occur via the primary research team, group identity cannot realistically be masked. However, we have included 2 statistical/methodological consultants in the project team who will be asked to verify all analyses using masked group assignment.

Recruitment for the study will begin in the fall of 2019, and interventions are expected to conclude in December 2019. A visual participant timeline is included in Figure 2.

SEL, SEC, and bullying potentially affect all schoolchildren; in recognition of this, states such as Indiana have convened bodies (eg, Indiana Commission on Improving the Status of Children in Indiana) and issued recommendations for the integration of SEL into schools [57]. At the same time, many barriers to effective program implementation remain [14-16], and the rigor of existing evaluation studies has been questioned [18]. Given the importance of these issues, this proposed study tests a novel, cost-effective intervention structure using a rigorous methodology, including this study protocol, which has been completed and registered before any subject enrollment.

This study will not have a data monitoring committee because the anticipated risks are minimal, and the active duration of the intervention is short within each cluster. Harms will nonetheless be evaluated in the highly unlikely event that they accrue in a manner attributable to this intervention. In addition, no interim analyses are planned other than following the 2 planned analytical timepoints indicated in Table 1. Data and analyses will be audited by multiple project consultants who are members of the project team but who are not part of Prevention Insights, the unit directly funded to support Claude McNeal Productions.

The proposed study has several potential limitations. The protocol is designed to test outcomes from a low-dose intervention, which, being 1 hour in length, fits within a standard class period and does not unduly burden school personnel. However, it is likely that multiple doses would provide a more robust effect (if an effect exists), and so, the pragmatic decision to test a single iteration of ACT OUT! for this study may contribute to a potential type II error. Furthermore, it is possible that an unexpectedly large percentage of students will be unable to be matched over time, especially at the 6-month posttest, due to the confidentiality requirements of the study. Use of an SGIC is a best-practice matching technique, but results from studies using this technique have disagreed about how to operationalize it and have produced a fairly wide range of matched percentages. However, collection of identifying data would require active parental consent, which itself has been shown to substantially reduce participation rates and to bias samples in ways that could meaningfully affect this study. Hence, use of the confidential SGIC to enable assent procedures is likely more robust than an identified matching protocol. Finally, it is possible that the treatment and control classes will display cross contamination, in which control subjects are informed by intervention subjects about the program. This can be identified at follow-up, and, more importantly, given that the emotional response to ACT OUT! is hypothesized to be an important mechanism of change, this threat is likely minimal because the control subjects will not have been exposed to the actual ACT OUT! experience.