Bystander Behavioral IntentionsNCT02919098
In-School Evaluation of Bystander: A Game-Based Intervention for Sexual Violence Prevention
A study testing Bystander, a game-based bystander intervention program and Infection City, a game-based program about meningitis in people with Bystander Behavioral Intentions, run by University of Chicago at 1 site in United States.
Trial summary
The investigators have developed a game-based sexual violence prevention program that uses a bystander intervention approach. This program is called Bystander and was designed for use with high school students in grades 9-12. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Bystander Behavioral Intentions
- What is being tested?
- Bystander, a game-based bystander intervention program and Infection City, a game-based program about meningitis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 601 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Oct 2017
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 13-19 years
- A student in grades 9-12 at one of three identified study site schools
- Able to speak and read English at a 7th grade level
- Provide informed consent and express willingness to complete the follow-up survey.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators have developed a game-based sexual violence prevention program that uses a bystander intervention approach. This program is called Bystander and was designed for use with high school students in grades 9-12. The goal of this research is to evaluate the efficacy and feasibility of Bystander when implemented in a school setting. The research will capture data on knowledge about sexual violence and harassment, as well as attitudes, self-efficacy, perceived social norms and behavioral intentions around bystander behaviors. This research will consist of a baseline survey, program participation, a immediate post-program survey, and a 3-month follow up survey with youth participants. It will also involve qualitative in-depth interviews with school staff and administration about the program.
Read the detailed description
Using the investigators' experience in game-based learning, digital media, behavior theory, and adolescent sexual and reproductive health, the investigators have developed a digital game-based sexual violence prevention program-Bystander-to be used with high school students to teach them about prosocial bystander behaviors and decrease acceptance of common rape myths. The goal of this research is to evaluate the efficacy and feasibility of Bystander when implemented in a school setting.
This study will evaluate Bystander, a four-module intervention program. Each module is designed to last one school class period. It includes 20 minutes of individual gameplay through an interactive narrative featuring prosocial bystander behaviors and discussions dispelling rape myths. Each module also includes facilitated class discussion about the topics covered that day.
The research team will conduct a pre/post efficacy and feasibility study that will capture data through a pre-, immediate post-, and 3-month follow up survey on knowledge about sexual violence and harassment, as well as attitudes, self-efficacy, perceived social norms and behavioral intentions around bystander behaviors (all measured at pre-, immediate post- and follow-up time points). It will also capture demographic information and previous bystander behaviors at baseline. It will finally involve qualitative in-depth interviews with school staff and administration about the program.
- Conditions
- Bystander Behavioral Intentions
- Being tested
- Bystander, a game-based bystander intervention program, Infection City, a game-based program about meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bystander, a game-based bystander intervention programBehavioural
A game-based, high school age-appropriate program delivered by trained facilitators for sexual violence and harassment intervention
Infection City, a game-based program about meningitisBehavioural
A game-based, high school age-appropriate program delivered by trained facilitators to teach students about meningitis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Two schools (all students grades 9-12) will serve as the intervention group.Participants will complete a baseline survey that will take no longer than 30 minutes. Afterwards, a trained facilitator will delivery a game-based bystander intervention program aimed at teaching students the knowledge and skills to prevent or intervene in instances in sexual harassment and violence among peers. This will last for 4 class periods (approximately 45 minutes each period, 180 minutes total). Afterwards, participants will complete an immediate post-program survey lasting no more than 30 minutes. Three months later, students will fill out an a follow up survey lasting no more than 30 minutes. School staff and administrators will be interviewed to gather their insights on the program's feasibility and acceptability. Receives: Behavioral: Bystander, a game-based bystander intervention program |
| Delayed Control | Placebo comparator | One school (all students grades 9-12) will serve as a delayed control group. Participants will complete a baseline survey that will take no longer than 30 minutes. Afterwards, a trained facilitator will delivery a game-based health program unrelated to sexual health, sexual violence, sexual harassment, and bystander behaviors. This will last for 4 class periods (approximately 45 minutes each period, 180 minutes total). Afterwards, participants will complete an immediate post-program survey lasting no more than 30 minutes. Three months later, students will fill out an a follow up survey lasting no more than 30 minutes.
After completing the follow-up survey, this group will follow the same procedures to deliver the bystander program and capture data outlined for the intervention group. Receives: Behavioral: Bystander, a game-based bystander intervention program; Behavioral: Infection City, a game-based program about meningitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in bystander behavioral intention
measured via validated 11-item Bystander Attitude Scale-Revised by McMahon et al 2014
Measured: pre, immediate post, 3 month follow up
change in attitudes towards sexual violence and harassment
measured via validated 22-item Modified Illinois Rape Myth Acceptance Scale by McMahon 2011
Measured: pre, immediate post, 3 month follow up
Secondary outcomes (7)
change in knowledge of sexual harassment and violence
measured via validated 7-item Legal Knowledge Scale (Maxwell 2003)
Measured: pre, immediate post, 3 month follow up
change in knowledge of sexual harassment and violence
measured via Knowledge of Sexual Violence and Harassment index (Banyard et al 2005)
Measured: pre, immediate post, 3 month follow up
change in perceived social norms for bystander behaviors
measured via validated Social Norms Scale from Gidycz et al 2011
Measured: pre, immediate post, 3 month follow up
change in self-efficacy for bystander behaviors
measured via validated 14-item Bystander Efficacy Scale by Banyard et al 2004
Measured: pre, immediate post, 3 month follow up
change in self-efficacy for bystander behaviors
measured via validated 10-item MVP Efficacy Scale by Ward 2001
Measured: pre, immediate post, 3 month follow up
change in decisional balance for bystander behaviors
measured via validated 10-item Bystander Decisional Balance Scale by Banyard 2004
Measured: pre, immediate post, 3 month follow up
change in normative beliefs around sexual violence
measured via validated 8-item Reaction to Offensive Language Scale--Comfort Subscale by Loh 2005
Measured: pre, immediate post, 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bystander Behavioral IntentionsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Gilliam, MD, MPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919098
- Sponsor's protocol ID
- IRB15-1404
- Status last verified
- Feb 2023
- First submitted
- 28 Sep 2016
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Maxwell, Christopher D., Amanda L. Robinson, and Lori A. Post.
McMahon, Sarah, and G. Lawrence Farmer.
McMahon S, Allen CT, Postmus JL, McMahon SM, Peterson NA, Lowe Hoffman M. Measuring bystander attitudes and behavior to prevent sexual violence. J Am Coll Health. 2014;62(1):58-66. doi: 10.1080/07448481.2013.849258.
PubMed 24313697Gidycz CA, Orchowski LM, Berkowitz AD. Preventing sexual aggression among college men: an evaluation of a social norms and bystander intervention program. Violence Against Women. 2011 Jun;17(6):720-42. doi: 10.1177/1077801211409727. Epub 2011 May 12.
PubMed 21571742Banyard, Victoria L., Elizabethe G. Plante, and Mary M. Moynihan.
Ward CL, Flisher AJ, Zissis C, Muller M, Lombard C. Exposure to violence and its relationship to psychopathology in adolescents. Inj Prev. 2001 Dec;7(4):297-301. doi: 10.1136/ip.7.4.297.
PubMed 11770655Loh C, Gidycz CA, Lobo TR, Luthra R. A prospective analysis of sexual assault perpetration: risk factors related to perpetrator characteristics. J Interpers Violence. 2005 Oct;20(10):1325-48. doi: 10.1177/0886260505278528.
PubMed 16162492
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-School Evaluation of Bystander: A Game-Based Intervention for Sexual Violence Prevention
- ClinicalTrials.gov ID
- NCT02919098
- Acronym / sponsor ID
- IRB15-1404
- Conditions
- Bystander Behavioral Intentions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 29 Sep 2016 (estimated)
- 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 investigators have developed a game-based sexual violence prevention program that uses a bystander intervention approach. This program is called Bystander and was designed for use with high school students in grades 9-12. The goal of this research is to evaluate the efficacy and feasibility of Bystander when implemented in a school setting. The research will capture data on knowledge about sexual violence and harassment, as well as attitudes, self-efficacy, perceived social norms and behavioral intentions around bystander behaviors. This research will consist of a baseline survey, program participation, a immediate post-program survey, and a 3-month follow up survey with youth participants. It will also involve qualitative in-depth interviews with school staff and administration about the program.
Detailed description
Using the investigators' experience in game-based learning, digital media, behavior theory, and adolescent sexual and reproductive health, the investigators have developed a digital game-based sexual violence prevention program-Bystander-to be used with high school students to teach them about prosocial bystander behaviors and decrease acceptance of common rape myths. The goal of this research is to evaluate the efficacy and feasibility of Bystander when implemented in a school setting.
This study will evaluate Bystander, a four-module intervention program. Each module is designed to last one school class period. It includes 20 minutes of individual gameplay through an interactive narrative featuring prosocial bystander behaviors and discussions dispelling rape myths. Each module also includes facilitated class discussion about the topics covered that day.
The research team will conduct a pre/post efficacy and feasibility study that will capture data through a pre-, immediate post-, and 3-month follow up survey on knowledge about sexual violence and harassment, as well as attitudes, self-efficacy, perceived social norms and behavioral intentions around bystander behaviors (all measured at pre-, immediate post- and follow-up time points). It will also capture demographic information and previous bystander behaviors at baseline. It will finally involve qualitative in-depth interviews with school staff and administration about the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Bystander, a game-based bystander intervention programTwo schools (all students grades 9-12) will serve as the intervention group.Participants will complete a baseline survey that will take no longer than 30 minutes. Afterwards, a trained facilitator will delivery a game-based bystander intervention program aimed at teaching students the knowledge and skills to prevent or intervene in instances in sexual harassment and violence among peers. This will last for 4 class periods (approximately 45 minutes each period, 180 minutes total). Afterwards, participants will complete an immediate post-program survey lasting no more than 30 minutes. Three months later, students will fill out an a follow up survey lasting no more than 30 minutes. School staff and administrators will be interviewed to gather their insights on the program's feasibility and acceptability. |
| Delayed Control | Placebo comparator | Behavioral: Bystander, a game-based bystander intervention program, Behavioral: Infection City, a game-based program about meningitisOne school (all students grades 9-12) will serve as a delayed control group. Participants will complete a baseline survey that will take no longer than 30 minutes. Afterwards, a trained facilitator will delivery a game-based health program unrelated to sexual health, sexual violence, sexual harassment, and bystander behaviors. This will last for 4 class periods (approximately 45 minutes each period, 180 minutes total). Afterwards, participants will complete an immediate post-program survey lasting no more than 30 minutes. Three months later, students will fill out an a follow up survey lasting no more than 30 minutes. After completing the follow-up survey, this group will follow the same procedures to deliver the bystander program and capture data outlined for the intervention group. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 13-19 years
- A student in grades 9-12 at one of three identified study site schools
- Able to speak and read English at a 7th grade level
- Provide informed consent and express willingness to complete the follow-up survey.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Bystander, a game-based bystander intervention programA game-based, high school age-appropriate program delivered by trained facilitators for sexual violence and harassment intervention | Behavioural | Delayed Control, Intervention |
| Infection City, a game-based program about meningitisA game-based, high school age-appropriate program delivered by trained facilitators to teach students about meningitis. | Behavioural | Delayed Control |
Primary outcome
change in bystander behavioral intention
Time frame: pre, immediate post, 3 month follow up
measured via validated 11-item Bystander Attitude Scale-Revised by McMahon et al 2014
change in attitudes towards sexual violence and harassment
Time frame: pre, immediate post, 3 month follow up
measured via validated 22-item Modified Illinois Rape Myth Acceptance Scale by McMahon 2011
7 secondary outcomes
change in knowledge of sexual harassment and violence
Time frame: pre, immediate post, 3 month follow up
change in knowledge of sexual harassment and violence
Time frame: pre, immediate post, 3 month follow up
change in perceived social norms for bystander behaviors
Time frame: pre, immediate post, 3 month follow up
change in self-efficacy for bystander behaviors
Time frame: pre, immediate post, 3 month follow up
change in self-efficacy for bystander behaviors
Time frame: pre, immediate post, 3 month follow up
change in decisional balance for bystander behaviors
Time frame: pre, immediate post, 3 month follow up
change in normative beliefs around sexual violence
Time frame: pre, immediate post, 3 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- BackgroundMaxwell, Christopher D., Amanda L. Robinson, and Lori A. Post.
- BackgroundMcMahon, Sarah, and G. Lawrence Farmer.
- Background: PubMed 24313697McMahon S, Allen CT, Postmus JL, McMahon SM, Peterson NA, Lowe Hoffman M. Measuring bystander attitudes and behavior to prevent sexual violence. J Am Coll Health. 2014;62(1):58-66. doi: 10.1080/07448481.2013.849258.
- Background: PubMed 21571742Gidycz CA, Orchowski LM, Berkowitz AD. Preventing sexual aggression among college men: an evaluation of a social norms and bystander intervention program. Violence Against Women. 2011 Jun;17(6):720-42. doi: 10.1177/1077801211409727. Epub 2011 May 12.
- BackgroundBanyard, Victoria L., Elizabethe G. Plante, and Mary M. Moynihan.
- Background: PubMed 11770655Ward CL, Flisher AJ, Zissis C, Muller M, Lombard C. Exposure to violence and its relationship to psychopathology in adolescents. Inj Prev. 2001 Dec;7(4):297-301. doi: 10.1136/ip.7.4.297.
- Background: PubMed 16162492Loh C, Gidycz CA, Lobo TR, Luthra R. A prospective analysis of sexual assault perpetration: risk factors related to perpetrator characteristics. J Interpers Violence. 2005 Oct;20(10):1325-48. doi: 10.1177/0886260505278528.
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.
Melissa Gilliam, MD, MPH principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bystander, a game-based bystander intervention program and Infection City, a game-based program about meningitis in people with Bystander Behavioral Intentions, run by University of Chicago 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 4 inclusion and 0 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: finished, as of the sponsor's last update on 23 Feb 2023. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in bystander behavioral intention (time frame: pre, immediate post, 3 month follow up). The study lists 2 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 NCT02919098, which also lists 7 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 23 Feb 2023.