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

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ClinicalTrials.gov Identifier: NCT04097496
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : November 14, 2019
Sponsor:
Collaborators:
Claude McNeal Productions
Lilly Endowment, Inc.
Information provided by (Responsible Party):
Jon Agley, Indiana University

Tracking Information
First Submitted Date  ICMJE September 17, 2019
First Posted Date  ICMJE September 20, 2019
Last Update Posted Date November 14, 2019
Actual Study Start Date  ICMJE October 16, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2019)
  • 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.
  • 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).
  • Change from Baseline Bullying Prevalence (objective) [ Time Frame: 3 months post-intervention ]
    Disciplinary referrals for bullying (aggregated, not individual)
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
  • Change from Baseline Social-Emotional Competence [ Time Frame: Separately, 2 weeks post-intervention, and 6 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.
  • Change from Baseline Bullying Prevalence (self-report) [ Time Frame: Separately, 2 weeks post-intervention, and 6 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).
  • Change from Baseline Bullying Prevalence (objective) [ Time Frame: 6 months post-intervention ]
    Disciplinary referrals for bullying (aggregated, not individual)
Change History Complete list of historical versions of study NCT04097496 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2019)
  • 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.
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2019)
  • Change from Baseline Social-Emotional Competence Sub-Domains (7th and 10th grades only) [ Time Frame: Separately, 2 weeks post-intervention, and 6 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.
  • 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.
  • Frequency of Truancy/Absenteeism [ Time Frame: 6 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.
  • Academic Performance using standard Grade Point Average [ Time Frame: 6 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of ACT OUT! Social Issue Theater on Youth and Adolescents
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (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.
Primary Purpose: Other
Condition  ICMJE
  • Social Competence
  • Bullying
Intervention  ICMJE Behavioral: Act Out! Intervention
Data included in the description of the intervention arm.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Act Out! Intervention
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2019)
1594
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jon Agley 8128553123 jagley@indiana.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04097496
Other Study ID Numbers  ICMJE 2019 0543
161999 ( Other Identifier: Indiana University )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Analytic Code
Time Frame: Data will be made available at the time of publication.
Access Criteria: Data will be open-access.
Responsible Party Jon Agley, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE
  • Claude McNeal Productions
  • Lilly Endowment, Inc.
Investigators  ICMJE Not Provided
PRS Account Indiana University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP