Assaultive BehaviorNCT02083302

Experimentally Testing the Effectiveness of a Campus-based Bystander Intervention

A study testing SCREAM Theater Dose 1, SCREAM Theater Doses 2 & SCREAM Theater Dose 3 and SCREAM Theater Dose 4 in people with Assaultive Behavior and Violence, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study was to examine the impact of a bystander intervention education program on college students' attitudes and behaviors associated with bystander intervention and sexual violence. Read more about this study

Who is it for?: Ages 18 to 21 yearsHealthy volunteers can take part
Conditions the study is for: Assaultive Behavior, Violence, Sexual Assault and Rape
What is being tested?: SCREAM Theater Dose 1, SCREAM Theater Doses 2 & SCREAM Theater Dose 3 and SCREAM Theater Dose 4
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,385 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Feb 2012
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 18 to 21 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Incoming first year students in the fall semester of 2010
Age 18 - 21
Attended Summer Orientation session

Who cannot join

Incoming transfer students
Younger than 18 or older than 21

Trial locations and contacts

1 site in 1 country.

United States1 site

Rutgers, the State University of New Jersey
New Brunswick, New Jersey, 08901

Other trials in United States

About this study

Read the detailed description

This study used a randomized control trial, longitudinal design to determine the impact of a peer education theater intervention on undergraduate student attitudes and behaviors related to sexual violence and bystander intervention. Students were assigned to either an experimental group (receiving 3-4 doses of the intervention ) or a comparison group (receiving 1 dose only) and were surveyed six times over an 18 month period.

Conditions: Assaultive Behavior, Violence, Sexual Assault and Rape, Helping Behavior
Being tested: SCREAM Theater Dose 1, SCREAM Theater Doses 2 & SCREAM Theater Dose 3, SCREAM Theater Dose 4
Keywords: campus sexual assault, bystander intervention
Medical subject headings: Helping Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCREAM Theater Dose 1Behavioural
Intervention 1: A three part program: a skit acted out by peer educators that depicts a sexual assault; an in-character question and answer session; and an out-of-character information session.
SCREAM Theater Doses 2 & SCREAM Theater Dose 3Behavioural
Dose 2: Scenes from the skit from Session 1 are re-created with small groups of students, but stop at certain points to allow audience members to explore different bystander intervention possibilities.
Dose 3: The six scenes outlined in Session 2 are presented individually to small groups of student participants; specifically outlining potential points of bystander intervention.
SCREAM Theater Dose 4Behavioural
Booster Session

Study groups in NCT02083302
Study group	Role	What they receive
Treatment1	Experimental	The Treatment1 group received SCREAM Theater Dose 1, SCREAM Theater Dose 2 and SCREAM Theater Dose 3. Receives: Behavioral: SCREAM Theater Dose 1; Behavioral: SCREAM Theater Doses 2 & SCREAM Theater Dose 3
Treatment2	Experimental	The Treatment2 group received SCREAM Theater Dose 1, SCREAM Theater Dose 2, SCREAM Theater Dose 3 and SCREAM Theater Dose 4. Receives: Behavioral: SCREAM Theater Dose 1; Behavioral: SCREAM Theater Doses 2 & SCREAM Theater Dose 3; Behavioral: SCREAM Theater Dose 4
Control	Other	The control group received SCREAM Theater Dose 1. Receives: Behavioral: SCREAM Theater Dose 1

What is being measured

The primary outcome is the main question the study is designed to answer.

Bystander Intentions
To measure intentions to be a bystander, we used the Bystander Attitude Scale, Revised (BAS-R) which is a modified version of Banyard's Bystander scale (Banyard, Plante, \& Moynihan, 2005; see McMahon et al., in press, for scale development information). Participants were asked to indicate how likely they were to engage in the behavior in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander intentions were assessed via (1) a paper survey in June, July or August 2010 (baseline) and (2) a follow-up web-based survey in early September, 2010. All study participants received one dose of the intervention in June, July or August.
Measured: Change from baseline in bystander intentions to up to three months
Bystander Intentions
To measure intentions to be a bystander, we used the Bystander Attitude Scale, Revised (BAS-R) which is a modified version of Banyard's Bystander scale (Banyard, Plante, \& Moynihan, 2005; see McMahon et al., in press, for scale development information). Participants were asked to indicate how likely they were to engage in the behavior in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander intentions were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; and (3) a follow-up web-based survey in early December 2010. After the September, 2010 follow-up survey, participants were randomized to either receive two additional doses in October, 2010 and November, 2010 (experimental group) or no additional doses (control group).
Measured: Change from baseline in bystander intentions to up to six months
Bystander Intentions
To measure intentions to be a bystander, we used the Bystander Attitude Scale, Revised (BAS-R) which is a modified version of Banyard's Bystander scale (Banyard, Plante, \& Moynihan, 2005; see McMahon et al., in press, for scale development information). Participants were asked to indicate how likely they were to engage in the behavior in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander intentions were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; and (4) a follow-up web-based survey in February, 2011.
Measured: Change from baseline in bystander intentions to up to eight months
Bystander Intentions
To measure intentions to be a bystander, we used the Bystander Attitude Scale, Revised (BAS-R) which is a modified version of Banyard's Bystander scale (Banyard, Plante, \& Moynihan, 2005; see McMahon et al., in press, for scale development information). Participants were asked to indicate how likely they were to engage in the behavior in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander intentions were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; and (5) a follow-up web-based survey in September, 2011. After the September, 2011 survey, experimental group participants were randomized to receive one additional dose (a booster session) or no additional doses.
Measured: Change from baseline in bystander intentions to up to fifteen months
Bystander Intentions
To measure intentions to be a bystander, we used the Bystander Attitude Scale, Revised (BAS-R) which is a modified version of Banyard's Bystander scale (Banyard, Plante, \& Moynihan, 2005; see McMahon et al., in press, for scale development information). Participants were asked to indicate how likely they were to engage in the behavior in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander intentions were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; (5) a follow-up web-based survey in September, 2011 and (6) a final follow-up web-based survey in February 2012.
Measured: Change from baseline in bystander intentions to up to twenty months

Secondary outcomes (30)

Bystander Friend Norms
To measure friends' norms about being a bystander, we used the Bystander Attitude Scale, Revised (BAS-R). In this portion of the survey, participants were asked to indicate how likely they think their friends would be to engage in the items on the BAS-R in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely."Students' bystander friend norms were assessed via (1) a paper survey in June, July or August 2010 (baseline) and (2) a follow-up web-based survey in early September, 2010. All study participants received one dose of the intervention in June, July or August.
Measured: Change from baseline in bystander friend norms to up to three months
Bystander Friend Norms
To measure friends' norms about being a bystander, we used the Bystander Attitude Scale, Revised (BAS-R). In this portion of the survey, participants were asked to indicate how likely they think their friends would be to engage in the items on the BAS-R in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander friend norms were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; and (3) a follow-up web-based survey in early December 2010. After the September, 2010 follow-up survey, participants were randomized to either receive two additional doses in October, 2010 and November, 2010 (experimental group) or no additional doses (control group).
Measured: Change from baseline in bystander friend norms to up to six months
Bystander Friend Norms
To measure friends' norms about being a bystander, we used the Bystander Attitude Scale, Revised (BAS-R). In this portion of the survey, participants were asked to indicate how likely they think their friends would be to engage in the items on the BAS-R in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander friend norms were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; and (4) a follow-up web-based survey in February, 2011.
Measured: Change from baseline in bystander friend norms to up to eight months
Bystander Friend Norms
To measure friends' norms about being a bystander, we used the Bystander Attitude Scale, Revised (BAS-R). In this portion of the survey, participants were asked to indicate how likely they think their friends would be to engage in the items on the BAS-R in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander friend norms were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; and (5) a follow-up web-based survey in September, 2011. After the September, 2011 survey, experimental group participants were randomized to receive one additional dose (a booster session) or no additional doses.
Measured: Change from baseline in bystander friend norms to up to fifteen months
Bystander Friend Norms
To measure friends' norms about being a bystander, we used the Bystander Attitude Scale, Revised (BAS-R). In this portion of the survey, participants were asked to indicate how likely they think their friends would be to engage in the items on the BAS-R in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander friend norms were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; (5) a follow-up web-based survey in September, 2011 and (6) a final follow-up web-based survey in February 2012.
Measured: Change from baseline in bystander friend norms to up to twenty months
Bystander Efficacy
To assess level of confidence in one's ability to intervene, the Bystander Efficacy Scale was used (Banyard et al., 2007). Respondents were asked to rate their level of confidence that they would perform certain bystander behaviors on a scale of 0 ("can't do") to 100 ("very certain can do"). Students' bystander efficacy was assessed via (1) a paper survey in June, July or August 2010 (baseline) and (2) a follow-up web-based survey in early September, 2010. All study participants received one dose of the intervention in June, July or August.
Measured: Change from baseline in bystander efficacy to up to three months
Bystander Efficacy
To assess level of confidence in one's ability to intervene, the Bystander Efficacy Scale was used (Banyard et al., 2007). Respondents were asked to rate their level of confidence that they would perform certain bystander behaviors on a scale of 0 ("can't do") to 100 ("very certain can do").Students' bystander efficacy was assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; and (3) a follow-up web-based survey in early December 2010. After the September, 2010 follow-up survey, participants were randomized to either receive two additional doses in October, 2010 and November, 2010 (experimental group) or no additional doses (control group).
Measured: Change from baseline in bystander efficacy to up to six months
Bystander Efficacy
To assess level of confidence in one's ability to intervene, the Bystander Efficacy Scale was used (Banyard et al., 2007). Respondents were asked to rate their level of confidence that they would perform certain bystander behaviors on a scale of 0 ("can't do") to 100 ("very certain can do"). Students' bystander efficacy was assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; and (4) a follow-up web-based survey in February, 2011.
Measured: Change from baseline in bystander efficacy to up to eight months
Bystander Efficacy
To assess level of confidence in one's ability to intervene, the Bystander Efficacy Scale was used (Banyard et al., 2007). Respondents were asked to rate their level of confidence that they would perform certain bystander behaviors on a scale of 0 ("can't do") to 100 ("very certain can do"). Students' bystander efficacy was assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; and (5) a follow-up web-based survey in September, 2011. After the September, 2011 survey, experimental group participants were randomized to receive one additional dose (a booster session) or no additional doses.
Measured: Change from baseline in bystander efficacy to up to fifteen months
Bystander Efficacy
To assess level of confidence in one's ability to intervene, the Bystander Efficacy Scale was used (Banyard et al., 2007). Respondents were asked to rate their level of confidence that they would perform certain bystander behaviors on a scale of 0 ("can't do") to 100 ("very certain can do"). Students' bystander intentions were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; (5) a follow-up web-based survey in September, 2011 and (6) a final follow-up web-based survey in February 2012.
Measured: Change from baseline in bystander efficacy to up to twenty months
Bystander Behavior
To measure actual bystander behavior, we used the Bystander Attitude Scale, Revised (BAS-R), which contains 18 items, each stating a different bystander behavior. For this portion of the survey, participants were asked whether they actually participated in the behavior in the previous month. Respondents can indicate "Yes", "No", or "Wasn't in the Situation".Students' bystander behavior was assessed via (1) a paper survey in June, July or August 2010 (baseline) and (2) a follow-up web-based survey in early September, 2010. All study participants received one dose of the intervention in June, July or August.
Measured: Change from baseline in bystander behavior to up to three months
Bystander Behavior
To measure actual bystander behavior, we used the Bystander Attitude Scale, Revised (BAS-R), which contains 18 items, each stating a different bystander behavior. For this portion of the survey, participants were asked whether they actually participated in the behavior in the previous month. Respondents can indicate "Yes", "No", or "Wasn't in the Situation".Students' bystander behavior was assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; and (3) a follow-up web-based survey in early December 2010. After the September, 2010 follow-up survey, participants were randomized to either receive two additional doses in October, 2010 and November, 2010 (experimental group) or no additional doses (control group).
Measured: Change from baseline in bystander behavior to up to six months
Bystander Behavior
To measure actual bystander behavior, we used the Bystander Attitude Scale, Revised (BAS-R), which contains 18 items, each stating a different bystander behavior. For this portion of the survey, participants were asked whether they actually participated in the behavior in the previous month. Respondents can indicate "Yes", "No", or "Wasn't in the Situation". Students' bystander behavior was assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; and (4) a follow-up web-based survey in February, 2011.
Measured: Change from baseline in bystander behavior to up to eight months
Bystander Behavior
To measure actual bystander behavior, we used the Bystander Attitude Scale, Revised (BAS-R), which contains 18 items, each stating a different bystander behavior. For this portion of the survey, participants were asked whether they actually participated in the behavior in the previous month. Respondents can indicate "Yes", "No", or "Wasn't in the Situation".Students' bystander behavior was assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; and (5) a follow-up web-based survey in September, 2011. After the September, 2011 survey, experimental group participants were randomized to receive one additional dose (a booster session) or no additional doses.
Measured: Change from baseline in bystander behavior to up to fifteen months
Bystander Behavior
To measure actual bystander behavior, we used the Bystander Attitude Scale, Revised (BAS-R), which contains 18 items, each stating a different bystander behavior. For this portion of the survey, participants were asked whether they actually participated in the behavior in the previous month. Respondents can indicate "Yes", "No", or "Wasn't in the Situation". Students' bystander behavior was assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; (5) a follow-up web-based survey in September, 2011 and (6) a final follow-up web-based survey in February 2012.
Measured: Change from baseline in bystander behavior to up to twenty months
Rape Myth Acceptance
A revised version of the Illinois Rape Myth Acceptance Scale (Payne, Lonsway, \& Fitzgerald, 1999) was used. The revised version (McMahon \& Farmer, 2011) was selected because the scale includes updated language for college students as well as having a specific focus on accountability for rape and victim blaming (for information on scale development, see McMahon \& Farmer, 2011). Students' rape myth acceptance was assessed via (1) a paper survey in June, July or August 2010 (baseline) and (2) a follow-up web-based survey in early September, 2010. All study participants received one dose of the intervention in June, July or August.
Measured: Change from baseline in rape myth acceptance to up to three months
Rape Myth Acceptance
A revised version of the Illinois Rape Myth Acceptance Scale (Payne, Lonsway, \& Fitzgerald, 1999) was used. The revised version (McMahon \& Farmer, 2011) was selected because the scale includes updated language for college students as well as having a specific focus on accountability for rape and victim blaming (for information on scale development, see McMahon \& Farmer, 2011).Students' rape myth acceptance was assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; and (3) a follow-up web-based survey in early December 2010. After the September, 2010 follow-up survey, participants were randomized to either receive two additional doses in October, 2010 and November, 2010 (experimental group) or no additional doses (control group).
Measured: Change from baseline in rape myth acceptance to up to six months
Rape Myth Acceptance
A revised version of the Illinois Rape Myth Acceptance Scale (Payne, Lonsway, \& Fitzgerald, 1999) was used. The revised version (McMahon \& Farmer, 2011) was selected because the scale includes updated language for college students as well as having a specific focus on accountability for rape and victim blaming (for information on scale development, see McMahon \& Farmer, 2011). Students' rape myth acceptance was assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011.
Measured: Change from baseline in rape myth acceptance to up to eight months
Rape Myth Acceptance
A revised version of the Illinois Rape Myth Acceptance Scale (Payne, Lonsway, \& Fitzgerald, 1999) was used. The revised version (McMahon \& Farmer, 2011) was selected because the scale includes updated language for college students as well as having a specific focus on accountability for rape and victim blaming (for information on scale development, see McMahon \& Farmer, 2011).Students' rape myth acceptance was assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; and (5) a follow-up web-based survey in September, 2011. After the September, 2011 survey, experimental group participants were randomized to receive one additional dose (a booster session) or no additional doses.
Measured: Change from baseline in rape myth acceptance to up to fifteen months
Rape Myth Acceptance
A revised version of the Illinois Rape Myth Acceptance Scale (Payne, Lonsway, \& Fitzgerald, 1999) was used. The revised version (McMahon \& Farmer, 2011) was selected because the scale includes updated language for college students as well as having a specific focus on accountability for rape and victim blaming (for information on scale development, see McMahon \& Farmer, 2011).Students' rape myth acceptance assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; (5) a follow-up web-based survey in September, 2011 and (6) a final follow-up web-based survey in February 2012.
Measured: Change from baseline in rape myth acceptance to up to twenty months
Proclivity to Perpetrate Sexual Violence
For proclivity to perpetrate, we used an item from Malamuth's (1989) Attraction to Sexual Aggression Scale and we created a question that combined items from Malamuth's scale and Lisak's Perpetrator History (PH) Scale (2000). These measures were assessed via (1) a paper survey in June, July or August 2010 (baseline) and (2) a follow-up web-based survey in early September, 2010. All study participants received one dose of the intervention in June, July or August.
Measured: Change from baseline in proclivity to perpetrate sexual violence to up to three months
Proclivity to Perpetrate Sexual Violence
For proclivity to perpetrate, we used an item from Malamuth's (1989) Attraction to Sexual Aggression Scale and we created a question that combined items from Malamuth's scale and Lisak's Perpetrator History (PH) Scale (2000). These measures were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; and (3) a follow-up web-based survey in early December 2010. After the September, 2010 follow-up survey, participants were randomized to either receive two additional doses in October, 2010 and November, 2010 (experimental group) or no additional doses (control group).
Measured: Change from baseline in proclivity to perpetrate sexual violence to up to six months
Proclivity to Perpetrate Sexual Violence
For proclivity to perpetrate, we used an item from Malamuth's (1989) Attraction to Sexual Aggression Scale and we created a question that combined items from Malamuth's scale and Lisak's Perpetrator History (PH) Scale (2000). These measures were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; and (4) a follow-up web-based survey in February, 2011.
Measured: Change from baseline in proclivity to perpetrate sexual violence to up to eight months
Proclivity to Perpetrate Sexual Violence
For proclivity to perpetrate, we used an item from Malamuth's (1989) Attraction to Sexual Aggression Scale and we created a question that combined items from Malamuth's scale and Lisak's Perpetrator History (PH) Scale (2000). These measures were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; and (5) a follow-up web-based survey in September, 2011. After the September, 2011 survey, experimental group participants were randomized to receive one additional dose (a booster session) or no additional doses.
Measured: Change from baseline in proclivity to perpetrate sexual violence up to fifteen months
Proclivity to Perpetrate Sexual Violence
For proclivity to perpetrate, we used an item from Malamuth's (1989) Attraction to Sexual Aggression Scale and we created a question that combined items from Malamuth's scale and Lisak's Perpetrator History (PH) Scale (2000). These measures were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; (5) a follow-up web-based survey in September, 2011 and (6) a final follow-up web-based survey in February 2012.
Measured: Change from baseline in proclivity to perpetrate sexual violence to up to twenty months
Sexual Violence Perpetration
Two questions from Lisak's Perpetrator History (PH) Scale (Lisak, Conklin, Hopper, Miller, Altschuler \& Smith, 2000) were used to assess actual perpetration. Students' past perpetration was assessed via (1) a paper survey in June, July or August 2010 (baseline) and (2) a follow-up web-based survey in early September, 2010. All study participants received one dose of the intervention in June, July or August.
Measured: Change from baseline in sexual violence perpetration to up to three months
Sexual Violence Perpetration
Two questions from Lisak's Perpetrator History (PH) Scale (Lisak, Conklin, Hopper, Miller, Altschuler \& Smith, 2000) were used to assess actual perpetration. Students' past perpetration was assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; and (3) a follow-up web-based survey in early December 2010. After the September, 2010 follow-up survey, participants were randomized to either receive two additional doses in October, 2010 and November, 2010 (experimental group) or no additional doses (control group).
Measured: Change from baseline in sexual violence perpetration to up to six months
Sexual Violence Perpetration
Two questions from Lisak's Perpetrator History (PH) Scale (Lisak, Conklin, Hopper, Miller, Altschuler \& Smith, 2000) were used to assess actual perpetration. Students' past perpetration was assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; and (4) a follow-up web-based survey in February, 2011.
Measured: Change from baseline in sexual violence perpetration to up to eight months
Sexual Violence Perpetration
Two questions from Lisak's Perpetrator History (PH) Scale (Lisak, Conklin, Hopper, Miller, Altschuler \& Smith, 2000) were used to assess actual perpetration. Students' past perpetration was assessed via(1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; and (5) a follow-up web-based survey in September, 2011. After the September, 2011 survey, experimental group participants were randomized to receive one additional dose (a booster session) or no additional doses.
Measured: Change from baseline in sexual violence perpetration to up to fifteen months
Sexual Violence Perpetration
Two questions from Lisak's Perpetrator History (PH) Scale (Lisak, Conklin, Hopper, Miller, Altschuler \& Smith, 2000) were used to assess actual perpetration. Students' past perpetration was assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; (5) a follow-up web-based survey in September, 2011 and (6) a final follow-up web-based survey in February 2012.
Measured: Change from baseline in sexual violence perpetration to up to twenty months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Feb 2012

First posted11 Mar 2014 (estimated)
Study startJun 2010
Primary completionFeb 2012
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Assaultive BehaviorStudies of the same condition, open and under way.
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: Parallel groups
Masking: None (open label)
Enrolment: 4,385 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02083302
Sponsor's protocol ID: 07-412M
Other IDs: 1R01CE001855-01
Status last verified: Mar 2014
First submitted: 3 Mar 2014
Last updated: 11 Mar 2014
Results posted: No
Data monitoring committee: No

Publications

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 24313697
McMahon, S., Hoffman, M., McMahon, S.M., Zucker, S. & Koenick, R.A. (2013). What Would You Do? Strategies for Bystander Intervention to Prevent Sexual Violence by College Students. Journal of College and Character, 14(2), p.141-152.

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Experimentally Testing the Effectiveness of a Campus-based Bystander Intervention
ClinicalTrials.gov ID: NCT02083302
Acronym / sponsor ID: 07-412M
Conditions: Assaultive Behavior, Violence, Sexual Assault and Rape, Helping Behavior
Keywords: campus sexual assault, bystander intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,385 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Collaborators: Centers for Disease Control and Prevention
Study start: Jun 2010
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 11 Mar 2014 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment1	Experimental	Behavioral: SCREAM Theater Dose 1, Behavioral: SCREAM Theater Doses 2 & SCREAM Theater Dose 3The Treatment1 group received SCREAM Theater Dose 1, SCREAM Theater Dose 2 and SCREAM Theater Dose 3.
Treatment2	Experimental	Behavioral: SCREAM Theater Dose 1, Behavioral: SCREAM Theater Doses 2 & SCREAM Theater Dose 3, Behavioral: SCREAM Theater Dose 4The Treatment2 group received SCREAM Theater Dose 1, SCREAM Theater Dose 2, SCREAM Theater Dose 3 and SCREAM Theater Dose 4.
Control	Other	Behavioral: SCREAM Theater Dose 1The control group received SCREAM Theater Dose 1.

Who may qualify

Ages: 18 to 21 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Incoming first year students in the fall semester of 2010
Age 18 - 21
Attended Summer Orientation session

Key exclusion criteria (2 listed)

Incoming transfer students
Younger than 18 or older than 21

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
SCREAM Theater Dose 1Intervention 1: A three part program: a skit acted out by peer educators that depicts a sexual assault; an in-character question and answer session; and an out-of-character information session.	Behavioural	Control, Treatment1, Treatment2
SCREAM Theater Doses 2 & SCREAM Theater Dose 3Dose 2: Scenes from the skit from Session 1 are re-created with small groups of students, but stop at certain points to allow audience members to explore different bystander intervention possibilities. Dose 3: The six scenes outlined in Session 2 are presented individually to small groups of student participants; specifically outlining potential points of bystander intervention.	Behavioural	Treatment1, Treatment2
SCREAM Theater Dose 4Booster Session	Behavioural	Treatment2

Primary outcome

Bystander Intentions
Time frame: Change from baseline in bystander intentions to up to three months
To measure intentions to be a bystander, we used the Bystander Attitude Scale, Revised (BAS-R) which is a modified version of Banyard's Bystander scale (Banyard, Plante, \& Moynihan, 2005; see McMahon et al., in press, for scale development information). Participants were asked to indicate how likely they were to engage in the behavior in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander intentions were assessed via (1) a paper survey in June, July or August 2010 (baseline) and (2) a follow-up web-based survey in early September, 2010. All study participants received one dose of the intervention in June, July or August.
Bystander Intentions
Time frame: Change from baseline in bystander intentions to up to six months
To measure intentions to be a bystander, we used the Bystander Attitude Scale, Revised (BAS-R) which is a modified version of Banyard's Bystander scale (Banyard, Plante, \& Moynihan, 2005; see McMahon et al., in press, for scale development information). Participants were asked to indicate how likely they were to engage in the behavior in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander intentions were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; and (3) a follow-up web-based survey in early December 2010. After the September, 2010 follow-up survey, participants were randomized to either receive two additional doses in October, 2010 and November, 2010 (experimental group) or no additional doses (control group).
Bystander Intentions
Time frame: Change from baseline in bystander intentions to up to eight months
To measure intentions to be a bystander, we used the Bystander Attitude Scale, Revised (BAS-R) which is a modified version of Banyard's Bystander scale (Banyard, Plante, \& Moynihan, 2005; see McMahon et al., in press, for scale development information). Participants were asked to indicate how likely they were to engage in the behavior in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander intentions were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; and (4) a follow-up web-based survey in February, 2011.
Bystander Intentions
Time frame: Change from baseline in bystander intentions to up to fifteen months
To measure intentions to be a bystander, we used the Bystander Attitude Scale, Revised (BAS-R) which is a modified version of Banyard's Bystander scale (Banyard, Plante, \& Moynihan, 2005; see McMahon et al., in press, for scale development information). Participants were asked to indicate how likely they were to engage in the behavior in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander intentions were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; and (5) a follow-up web-based survey in September, 2011. After the September, 2011 survey, experimental group participants were randomized to receive one additional dose (a booster session) or no additional doses.
Bystander Intentions
Time frame: Change from baseline in bystander intentions to up to twenty months
To measure intentions to be a bystander, we used the Bystander Attitude Scale, Revised (BAS-R) which is a modified version of Banyard's Bystander scale (Banyard, Plante, \& Moynihan, 2005; see McMahon et al., in press, for scale development information). Participants were asked to indicate how likely they were to engage in the behavior in the future on a Likert scale from 1 - 5, "Unlikely" to "Very likely." Students' bystander intentions were assessed via (1) a paper survey in June, July or August 2010 (baseline); (2) a follow-up web-based survey in early September, 2010; (3) a follow-up web-based survey in early December 2010; (4) a follow-up web-based survey in February, 2011; (5) a follow-up web-based survey in September, 2011 and (6) a final follow-up web-based survey in February 2012.

30 secondary outcomes

Bystander Friend Norms
Time frame: Change from baseline in bystander friend norms to up to three months
Bystander Friend Norms
Time frame: Change from baseline in bystander friend norms to up to six months
Bystander Friend Norms
Time frame: Change from baseline in bystander friend norms to up to eight months
Bystander Friend Norms
Time frame: Change from baseline in bystander friend norms to up to fifteen months
Bystander Friend Norms
Time frame: Change from baseline in bystander friend norms to up to twenty months
Bystander Efficacy
Time frame: Change from baseline in bystander efficacy to up to three months
Bystander Efficacy
Time frame: Change from baseline in bystander efficacy to up to six months
Bystander Efficacy
Time frame: Change from baseline in bystander efficacy to up to eight months
Bystander Efficacy
Time frame: Change from baseline in bystander efficacy to up to fifteen months
Bystander Efficacy
Time frame: Change from baseline in bystander efficacy to up to twenty months
Bystander Behavior
Time frame: Change from baseline in bystander behavior to up to three months
Bystander Behavior
Time frame: Change from baseline in bystander behavior to up to six months
Bystander Behavior
Time frame: Change from baseline in bystander behavior to up to eight months
Bystander Behavior
Time frame: Change from baseline in bystander behavior to up to fifteen months
Bystander Behavior
Time frame: Change from baseline in bystander behavior to up to twenty months
Rape Myth Acceptance
Time frame: Change from baseline in rape myth acceptance to up to three months
Rape Myth Acceptance
Time frame: Change from baseline in rape myth acceptance to up to six months
Rape Myth Acceptance
Time frame: Change from baseline in rape myth acceptance to up to eight months
Rape Myth Acceptance
Time frame: Change from baseline in rape myth acceptance to up to fifteen months
Rape Myth Acceptance
Time frame: Change from baseline in rape myth acceptance to up to twenty months
Proclivity to Perpetrate Sexual Violence
Time frame: Change from baseline in proclivity to perpetrate sexual violence to up to three months
Proclivity to Perpetrate Sexual Violence
Time frame: Change from baseline in proclivity to perpetrate sexual violence to up to six months
Proclivity to Perpetrate Sexual Violence
Time frame: Change from baseline in proclivity to perpetrate sexual violence to up to eight months
Proclivity to Perpetrate Sexual Violence
Time frame: Change from baseline in proclivity to perpetrate sexual violence up to fifteen months
Proclivity to Perpetrate Sexual Violence
Time frame: Change from baseline in proclivity to perpetrate sexual violence to up to twenty months
Sexual Violence Perpetration
Time frame: Change from baseline in sexual violence perpetration to up to three months
Sexual Violence Perpetration
Time frame: Change from baseline in sexual violence perpetration to up to six months
Sexual Violence Perpetration
Time frame: Change from baseline in sexual violence perpetration to up to eight months
Sexual Violence Perpetration
Time frame: Change from baseline in sexual violence perpetration to up to fifteen months
Sexual Violence Perpetration
Time frame: Change from baseline in sexual violence perpetration to up to twenty months

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 11 Mar 2014.
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.
Results publicationMcMahon, S., Hoffman, M., McMahon, S.M., Zucker, S. & Koenick, R.A. (2013). What Would You Do? Strategies for Bystander Intervention to Prevent Sexual Violence by College Students. Journal of College and Character, 14(2), p.141-152.

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.

Sarah McMahon, PhD principal investigator

Rutgers University School of Social Work

Judy Postmus, PhD principal investigator

Rutgers University School of Social Work

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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: finished, as of the sponsor's last update on 11 Mar 2014. 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 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?

Bystander Intentions (time frame: Change from baseline in bystander intentions to up to three months). The study lists 5 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 NCT02083302, which also lists 2 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 11 Mar 2014.