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

September 4, 2020 updated by: Jon Agley, Indiana University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1537

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46204
        • Claude McNeal Productions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Act Out! Intervention
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
Data included in the description of the intervention arm.
NO_INTERVENTION: Control
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
Time Frame: 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.
Separately, 2 weeks post-intervention, and 3 months post-intervention
Change from Baseline Bullying Prevalence (self-report)
Time Frame: 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).
Separately, 2 weeks post-intervention, and 3 months post-intervention
Change from Baseline Bullying Prevalence (objective)
Time Frame: 3 months post-intervention
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)
Time Frame: Separately, 2 weeks post-intervention, and 3 months post-intervention
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
Time Frame: 2 weeks post-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
Time Frame: 3 months post-intervention
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
Time Frame: 3 months post-intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Claude McNeal Productions
Lilly Endowment, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 16, 2019

Primary Completion (ACTUAL)

March 15, 2020

Study Completion (ACTUAL)

March 15, 2020

Study Registration Dates

First Submitted

September 17, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (ACTUAL)

September 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019 0543
  • 161999 (OTHER: Indiana University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in study publications will be made available in fully de-identified form. The study protocol will be published in an open-access journal and will include the statistical analysis plan, per SPIRIT 2013 recommendations.

All forms related to recruitment and protocol execution will also be made available as supplemental files in appropriate outcome publications. The analytic code for each outcome publication will be published as a supplemental file with the corresponding paper.

IPD Sharing Time Frame

Data will be made available at the time of publication.

IPD Sharing Access Criteria

Data will be open-access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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