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

Bullying Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04097496
• Other study ID #: 2019 0543
• Secondary ID: 161999
• Status: Terminated
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: September 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1537
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bullying
• Social Competence

Intervention

Behavioral:
• Act Out! Intervention
Data included in the description of the intervention arm.

Locations

Country	Name	City	State
United States	Claude McNeal Productions	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Claude McNeal Productions, Lilly Endowment, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson 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. — View Citation

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. — View 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/

Davies MH. The origins and practice of psychodrama. Br J Psychiatry. 1976 Sep;129:201-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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.

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. — View Citation

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. — View Citation

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.

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

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.

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change from Baseline Bullying Prevalence (objective)	Disciplinary referrals for bullying (aggregated, not individual)	3 months post-intervention
Secondary	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.	Separately, 2 weeks post-intervention, and 3 months post-intervention
Secondary	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.	2 weeks post-intervention
Secondary	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.	3 months post-intervention
Secondary	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).	3 months post-intervention