Bystander BehaviorNCT03056560
Evaluating a Video Bystander Program for First-Year College Students
A study testing TakeCARE (video bystander program) in people with Bystander Behavior, run by Southern Methodist University at 1 site in United States.
Trial summary
This study will evaluate an innovative video bystander program, which has the potential to be implemented broadly and cost-effectively across college campuses. Half of the participants will receive the video bystander program, and the other half will not. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bystander Behavior
- What is being tested?
- TakeCARE (video bystander program)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Mar 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- first-year college students
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TakeCARE: A Video Bystander Program to Prevent Sexual Violence on College Campuses
This study will evaluate an innovative video bystander program, which has the potential to be implemented broadly and cost-effectively across college campuses. Half of the participants will receive the video bystander program, and the other half will not.
Read the detailed description
Sexual violence, which includes both sexual coercion and assault, is a significant problem on college campuses due to its high prevalence and adverse consequences. This research will evaluate an innovative video bystander program, which has the potential to be implemented broadly and cost-effectively across college campuses. We will recruit first-year college students from each of 4 college campuses (Southern Methodist University, Marquette University, William Paterson University, and Stony Brook University).
The video bystander program (TakeCARE) starts with a narrator acknowledging the various demands placed on students in attempting to balance adult responsibilities with the social opportunities of college, as well as the importance of keeping safe while engaging in these social activities. The program describes how likely it is that people they know may become a victim of sexual violence and how they can help "take care of their friends" to help prevent victimization. TakeCARE includes 3 video vignettes that demonstrate ways that students can intervene when they see sexual coercion, relationship violence, or other situations that might result in harm.
After a baseline assessment, students will be randomly assigned to view one of two video programs: TakeCARE (the video bystander program) or a control video program. A post-treatment assessment will be completed within a week of viewing the video program, and follow-up assessments will be completed 2 months and 6 months after baseline.
- Conditions
- Bystander Behavior
- Being tested
- TakeCARE (video bystander program)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TakeCARE (video bystander program)Behavioural
brief video encouraging active responses to high-risk situations for campus violence
| Study group | Role | What they receive |
|---|---|---|
| Video Bystander Program | Experimental | TakeCARE video Receives: Behavioral: TakeCARE (video bystander program) |
| Control Video | No intervention | Study Skills Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bystander behavior
Self-report measure: Bystander Behavior Scale
Measured: Baseline and 2 months
Secondary outcomes (2)
Change in bystander behavior
Observations using virtual reality protocol
Measured: Baseline and 2 months
Change in bystander efficacy
Self-report measure: Bystander Efficacy Scale
Measured: Baseline and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study startAug 2016
- Primary completionJul 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bystander 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Methodist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernest Jouriles, Southern Methodist University
- Investigators
- Ernest Jouriles, Ph.D., Principal investigator, Southern Methodist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056560
- Sponsor's protocol ID
- 5R21HD085063
- Status last verified
- May 2018
- First submitted
- 13 Feb 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TakeCARE: A Video Bystander Program to Prevent Sexual Violence on College Campuses
- ClinicalTrials.gov ID
- NCT03056560
- Acronym / sponsor ID
- 5R21HD085063
- Conditions
- Bystander Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Southern Methodist UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 17 Feb 2017 (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.
This study will evaluate an innovative video bystander program, which has the potential to be implemented broadly and cost-effectively across college campuses. Half of the participants will receive the video bystander program, and the other half will not.
Detailed description
Sexual violence, which includes both sexual coercion and assault, is a significant problem on college campuses due to its high prevalence and adverse consequences. This research will evaluate an innovative video bystander program, which has the potential to be implemented broadly and cost-effectively across college campuses. We will recruit first-year college students from each of 4 college campuses (Southern Methodist University, Marquette University, William Paterson University, and Stony Brook University).
The video bystander program (TakeCARE) starts with a narrator acknowledging the various demands placed on students in attempting to balance adult responsibilities with the social opportunities of college, as well as the importance of keeping safe while engaging in these social activities. The program describes how likely it is that people they know may become a victim of sexual violence and how they can help "take care of their friends" to help prevent victimization. TakeCARE includes 3 video vignettes that demonstrate ways that students can intervene when they see sexual coercion, relationship violence, or other situations that might result in harm.
After a baseline assessment, students will be randomly assigned to view one of two video programs: TakeCARE (the video bystander program) or a control video program. A post-treatment assessment will be completed within a week of viewing the video program, and follow-up assessments will be completed 2 months and 6 months after baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Bystander Program | Experimental | Behavioral: TakeCARE (video bystander program)TakeCARE video |
| Control Video | No intervention | –Study Skills Video |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- first-year college students
Key exclusion criteria (1 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 |
|---|---|---|
| TakeCARE (video bystander program)brief video encouraging active responses to high-risk situations for campus violence | Behavioural | Video Bystander Program |
Primary outcome
Change in bystander behavior
Time frame: Baseline and 2 months
Self-report measure: Bystander Behavior Scale
2 secondary outcomes
Change in bystander behavior
Time frame: Baseline and 2 months
Change in bystander efficacy
Time frame: Baseline and 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: No
Related trials for Bystander Behavior
Recruiting
EAT: A Reliable Eating Assessment Technology for Free-living Individuals
Wearable Electronic Device
Recruiting
Motivations, Attitudes, and Perceptions Study
Alcohol Drinking, Sexual Violence
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.
Ernest Jouriles, Ph.D. principal investigator
Southern Methodist University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TakeCARE (video bystander program) in people with Bystander Behavior, run by Southern Methodist 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 1 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: status not confirmed, as of the sponsor's last update on 3 May 2018. 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?
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 in bystander behavior (time frame: Baseline and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2018.