Social CompetenceNCT04097496
Effects of ACT OUT! Social Issue Theater on Youth and Adolescents
A study testing Act Out! Intervention in people with Social Competence and Bullying, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Social Competence, Bullying
- What is being tested?
- Act Out! Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,537 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2019to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Classrooms must be comprised of 4th grade (Elementary), 7th grade (Middle), or 10th grade (High) students
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Claude McNeal Productions
Indianapolis, Indiana, 46204
About this study
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
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.
Read the 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.
- Conditions
- Social Competence, Bullying
- Being tested
- Act Out! Intervention
- Medical subject headings
- Social Skills, Bullying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Act Out! InterventionBehavioural
Data included in the description of the intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Separately, 2 weeks post-intervention, and 3 months post-intervention
Change from Baseline Bullying Prevalence (objective)
Disciplinary referrals for bullying (aggregated, not individual)
Measured: 3 months post-intervention
Secondary outcomes (4)
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.
Measured: Separately, 2 weeks post-intervention, and 3 months post-intervention
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.
Measured: 2 weeks post-intervention
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.
Measured: 3 months post-intervention
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).
Measured: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start16 Oct 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Why it stopped: COVID-19 pandemic and related school policies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Social CompetenceStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,537 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Claude McNeal Productions, Lilly Endowment, Inc.
- Responsible party
- Principal investigator, Jon Agley, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097496
- Sponsor's protocol ID
- 2019 0543
- Other IDs
- 161999
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Claude McNeal Productions. Act Out Ensemble [Internet]. Claude McNeal Productions. 2019 [cited 11 September 2019]. Available from: https://www.claudemcnealproductions.com/act-out-ensemble/
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.
PubMed 21291449Rosenstein L. On Aristotle and thought in drama. Critical Inquiry. 1977;3(3):543-65.
Davies MH. The origins and practice of psychodrama. Br J Psychiatry. 1976 Sep;129:201-6. doi: 10.1192/bjp.129.3.201.
PubMed 786420Krahé 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.
PubMed 20973661Lightfoot 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.
PubMed 26300693Joronen 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.
PubMed 21385761Cheadle 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.
PubMed 22118997Belknap 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.
PubMed 23583507Joronen 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.
PubMed 18537845Sussman 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.
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.
PubMed 23303884Mantz 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.
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.
PubMed 29726005
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04097496
- Acronym / sponsor ID
- 2019 0543
- Conditions
- Social Competence, Bullying
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic and related school policies.
- Enrolment
- 1,537 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Claude McNeal Productions, Lilly Endowment, Inc.
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 20 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Act Out! Intervention | Experimental | Behavioral: Act Out! InterventionEligible 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Classrooms must be comprised of 4th grade (Elementary), 7th grade (Middle), or 10th grade (High) students
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Act Out! InterventionData included in the description of the intervention arm. | Behavioural | Act Out! Intervention |
Primary outcome
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)
4 secondary outcomes
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
Receptivity to the Act Out! Intervention
Time frame: 2 weeks post-intervention
Frequency of Truancy/Absenteeism
Time frame: 3 months post-intervention
Academic Performance using standard Grade Point Average
Time frame: 3 months post-intervention
Results and safety
The study was stopped early (reason given: COVID-19 pandemic and related school policies.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- BackgroundClaude McNeal Productions. Act Out Ensemble [Internet]. Claude McNeal Productions. 2019 [cited 11 September 2019]. Available from: https://www.claudemcnealproductions.com/act-out-ensemble/
- Background: PubMed 21291449Durlak 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.
- BackgroundRosenstein L. On Aristotle and thought in drama. Critical Inquiry. 1977;3(3):543-65.
- Background: PubMed 786420Davies MH. The origins and practice of psychodrama. Br J Psychiatry. 1976 Sep;129:201-6. doi: 10.1192/bjp.129.3.201.
- BackgroundKrahé 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: PubMed 20973661Lauby 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.
- Background: PubMed 26300693Lightfoot 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.
- Background: PubMed 21385761Joronen 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.
- Background: PubMed 22118997Cheadle 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.
- Background: PubMed 23583507Belknap 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.
- Background: PubMed 18537845Joronen 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.
- BackgroundSussman 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Act Out! Intervention in people with Social Competence and Bullying, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 pandemic and related school policies.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Social-Emotional Competence (time frame: Separately, 2 weeks post-intervention, and 3 months post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04097496, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.