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

NCT04097496 | Terminated

• 2 other identifiers: 2019 0543161999
• Study Type: interventional
• Target: 1,537
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Competence; Bullying

Outcome Measures

Primary Outcomes (3)

• 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.

  Separately, 2 weeks post-intervention, and 3 months post-intervention

• 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).

  Separately, 2 weeks post-intervention, and 3 months post-intervention

• Change from Baseline Bullying Prevalence (objective)

  Disciplinary referrals for bullying (aggregated, not individual)

  3 months post-intervention

Secondary Outcomes (4)

• Change from Baseline Social-Emotional Competence Sub-Domains (7th and 10th grades only)

  Separately, 2 weeks post-intervention, and 3 months post-intervention

• Receptivity to the Act Out! Intervention

  2 weeks post-intervention

• Frequency of Truancy/Absenteeism

  3 months post-intervention

• Academic Performance using standard Grade Point Average

  3 months post-intervention

Study Arms (2)

Act Out! Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Act Out! Intervention BEHAVIORAL

Data included in the description of the intervention arm.

Act Out! Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Classrooms must be comprised of 4th grade (Elementary), 7th grade (Middle), or 10th grade (High) students

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• Claude McNeal Productions: collaborator
• Lilly Endowment, Inc.: collaborator

Study Sites (1)

Claude McNeal Productions

Indianapolis, Indiana, 46204, United States

Location

Related Publications (18)

• Claude McNeal Productions. Act Out Ensemble [Internet]. Claude McNeal Productions. 2019 [cited 11 September 2019]. Available from: https://www.claudemcnealproductions.com/act-out-ensemble/

  BACKGROUND

• Durlak JA, Weissberg RP, Dymnicki AB, Taylor RD, Schellinger KB. The impact of enhancing students' social and emotional learning: a meta-analysis of school-based universal interventions. Child Dev. 2011 Jan-Feb;82(1):405-32. doi: 10.1111/j.1467-8624.2010.01564.x.

  PMID: 21291449 BACKGROUND

• Rosenstein L. On Aristotle and thought in drama. Critical Inquiry. 1977;3(3):543-65.

  BACKGROUND

• Davies MH. The origins and practice of psychodrama. Br J Psychiatry. 1976 Sep;129:201-6. doi: 10.1192/bjp.129.3.201.

  PMID: 786420 BACKGROUND

• Krahé B, Knappert L. A group-randomized evaluation of a theatre-based sexual abuse prevention programme for primary school children in Germany. J Community Appl Soc Psychol. 2009;19(4):321-9.

  BACKGROUND

• Lauby JL, LaPollo AB, Herbst JH, Painter TM, Batson H, Pierre A, Milnamow M. Preventing AIDS through live movement and sound: Efficacy of a theater-based HIV prevention intervention delivered to high-risk male adolescents in juvenile justice settings. AIDS Educ Prev. 2010 Oct;22(5):402-16. doi: 10.1521/aeap.2010.22.5.402.

  PMID: 20973661 BACKGROUND

• Lightfoot AF, Taboada A, Taggart T, Tran T, Burtaine A. 'I learned to be okay with talking about sex and safety': assessing the efficacy of a theatre-based HIV prevention approach for adolescents in North Carolina. Sex Educ. 2015;15(4):348-363. doi: 10.1080/14681811.2015.1025947.

  PMID: 26300693 BACKGROUND

• Joronen K, Konu A, Rankin HS, Astedt-Kurki P. An evaluation of a drama program to enhance social relationships and anti-bullying at elementary school: a controlled study. Health Promot Int. 2012 Mar;27(1):5-14. doi: 10.1093/heapro/dar012. Epub 2011 Mar 7.

  PMID: 21385761 BACKGROUND

• Cheadle A, Cahill C, Schwartz PM, Edmiston J, Johnson S, Davis L, Robbins C. Engaging youth in learning about healthful eating and active living: an evaluation of Educational Theater Programs. J Nutr Educ Behav. 2012 Mar-Apr;44(2):160-5. doi: 10.1016/j.jneb.2011.06.005. Epub 2011 Nov 25.

  PMID: 22118997 BACKGROUND

• Belknap RA, Haglund K, Felzer H, Pruszynski J, Schneider J. A theater intervention to prevent teen dating violence for Mexican-American middle school students. J Adolesc Health. 2013 Jul;53(1):62-7. doi: 10.1016/j.jadohealth.2013.02.006. Epub 2013 Apr 11.

  PMID: 23583507 BACKGROUND

• Joronen K, Rankin SH, Astedt-Kurki P. School-based drama interventions in health promotion for children and adolescents: systematic review. J Adv Nurs. 2008 Jul;63(2):116-31. doi: 10.1111/j.1365-2648.2008.04634.x.

  PMID: 18537845 BACKGROUND

• Sussman SY. Evaluating the efficacy of Project TND: Evidence from seven research trials. In: Scheier LM, editor. Handbook of adolescent drug use prevention: Research, intervention strategies, and practice. Washington DC: American Psychological Association; 2015. p. 159-76.

  BACKGROUND

• Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.

  PMID: 23303884 BACKGROUND

• Mantz LS, Bear GC, Yang C, Harris, A. The Delaware Social-Emotional Competency Scale (DSECS-S): Evidence of validity and reliability. Child Indic Res. 2018;11(1):137-57.

  BACKGROUND

• Thomas HJ, Scott JG, Coates JM, Connor JP. Development and validation of the Bullying and Cyberbullying Scale for Adolescents: A multi-dimensional measurement model. Br J Educ Psychol. 2019 Mar;89(1):75-94. doi: 10.1111/bjep.12223. Epub 2018 May 3.

  PMID: 29726005 BACKGROUND

• Dent CW, Sussman S, Hennesy M, Galaif ER, Stacy AW, Moss M, Craig S. Implementation and process evaluation of a school-based drug abuse prevention program: Project Towards No Drug Abuse. J Drug Educ. 1998;28(4):361-75. doi: 10.2190/UFY9-WHXX-AFC1-RXB1.

  PMID: 10097485 BACKGROUND

• Agley J, Jun M, Eldridge L, Agley DL, Xiao Y, Sussman S, Golzarri-Arroyo L, Dickinson SL, Jayawardene W, Gassman R. Effects of ACT Out! Social Issue Theater on Social-Emotional Competence and Bullying in Youth and Adolescents: Cluster Randomized Controlled Trial. JMIR Ment Health. 2021 Jan 6;8(1):e25860. doi: 10.2196/25860.

  PMID: 33338986 DERIVED

• Agley J, Jayawardene W, Jun M, Agley DL, Gassman R, Sussman S, Xiao Y, Dickinson SL. Effects of the ACT OUT! Social Issue Theater Program on Social-Emotional Competence and Bullying in Youth and Adolescents: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2020 Apr 13;9(4):e17900. doi: 10.2196/17900.

  PMID: 32281541 DERIVED

MeSH Terms

Conditions

Social Skills; Bullying

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Aggression; Behavioral Symptoms; Harassment, Non-Sexual

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 20, 2019
• Study Start: October 16, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made available at the time of publication.
• Access Criteria: Data will be open-access.

Locations

US (1)