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

Primary Purpose

Social Competence, Bullying

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Act Out! Intervention
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Social Competence

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Claude McNeal Productions

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Act Out! Intervention

Control

Arm Description

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.

Classrooms randomized to this arm will continue with their school day as normal, except that they will complete the data collection tools.

Outcomes

Primary Outcome Measures

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.
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).
Change from Baseline Bullying Prevalence (objective)
Disciplinary referrals for bullying (aggregated, not individual)

Secondary Outcome Measures

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.
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.
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.
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).

Full Information

First Posted
September 17, 2019
Last Updated
September 4, 2020
Sponsor
Indiana University
Collaborators
Claude McNeal Productions, Lilly Endowment, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04097496
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 pandemic and related school policies.
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Claude McNeal Productions, Lilly Endowment, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Competence, Bullying

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
1537 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Act Out! Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Classrooms randomized to this arm will continue with their school day as normal, except that they will complete the data collection tools.
Intervention Type
Behavioral
Intervention Name(s)
Act Out! Intervention
Intervention Description
Data included in the description of the intervention arm.
Primary Outcome Measure Information:
Title
Change from Baseline Social-Emotional Competence
Description
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.
Time Frame
Separately, 2 weeks post-intervention, and 3 months post-intervention
Title
Change from Baseline Bullying Prevalence (self-report)
Description
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).
Time Frame
Separately, 2 weeks post-intervention, and 3 months post-intervention
Title
Change from Baseline Bullying Prevalence (objective)
Description
Disciplinary referrals for bullying (aggregated, not individual)
Time Frame
3 months post-intervention
Secondary Outcome Measure Information:
Title
Change from Baseline Social-Emotional Competence Sub-Domains (7th and 10th grades only)
Description
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.
Time Frame
Separately, 2 weeks post-intervention, and 3 months post-intervention
Title
Receptivity to the Act Out! Intervention
Description
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.
Time Frame
2 weeks post-intervention
Title
Frequency of Truancy/Absenteeism
Description
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.
Time Frame
3 months post-intervention
Title
Academic Performance using standard Grade Point Average
Description
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).
Time Frame
3 months post-intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Claude McNeal Productions
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
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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Effects of ACT OUT! Social Issue Theater on Youth and Adolescents

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