Clinical trial NCT04097496: Effects of ACT OUT! Social Issue Theater on Youth and Adolescents
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Social Competence
Bullying
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Claude McNeal Productions
name: Lilly Endowment, Inc.
First posted: 2019-09-20
Enrollment: 1537
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change from Baseline Social-Emotional Competence
timeFrame: Separately, 2 weeks post-intervention, and 3 months post-intervention
measure: Change from Baseline Bullying Prevalence (self-report)
timeFrame: Separately, 2 weeks post-intervention, and 3 months post-intervention
measure: Change from Baseline Bullying Prevalence (objective)
timeFrame: 3 months post-intervention
Secondary outcomes:
measure: Change from Baseline Social-Emotional Competence Sub-Domains (7th and 10th grades only)
timeFrame: Separately, 2 weeks post-intervention, and 3 months post-intervention
measure: Receptivity to the Act Out! Intervention
timeFrame: 2 weeks post-intervention
measure: Frequency of Truancy/Absenteeism
timeFrame: 3 months post-intervention
measure: Academic Performance using standard Grade Point Average
timeFrame: 3 months post-intervention
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Claude McNeal Productions
state: Indiana
Study officials:
References:
citation: Claude McNeal Productions. Act Out Ensemble [Internet]. Claude McNeal Productions. 2019 [cited 11 September 2019]. Available from: https://www.claudemcnealproductions.com/act-out-ensemble/
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