Sexual ViolenceNCT03037866
Primary Prevention of Sexual Violence Among College Students
A study testing LifeSkills Training for College in people with Sexual Violence and Substance Use, run by National Health Promotion Associates, Inc..
Trial summary
This project is designed to address the urgent need for an effective primary prevention approach to the problem of sexual violence among college students. The project involves developing, feasibility testing, and testing for effectiveness an innovative new approach to the primary prevention of sexual violence… Read more about this study
- Who is it for?
- Ages 18 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Violence, Substance Use, Substance Abuse
- What is being tested?
- LifeSkills Training for College
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jun 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 18 to 20 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- College students
Who cannot join
- Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
- Any previous experience with the intervention program will also exclude adolescents from participating
About this study
This project is designed to address the urgent need for an effective primary prevention approach to the problem of sexual violence among college students. The project involves developing, feasibility testing, and testing for effectiveness an innovative new approach to the primary prevention of sexual violence, alcohol, and drug abuse among college students utilizing both online e-learning and small group facilitator-led intervention modalities. The intervention is an adaptation of the successful evidence-based substance abuse and violence prevention approach called Life Skills Training (LST). The adapted intervention is designed to address the relationship between sexual violence and substance abuse; positively change social norms surrounding alcohol/drug abuse and sexual violence; train bystanders to identify and appropriately respond to problematic situations; and build social, self-regulation, and relationship skills through interactive learning and behavioral rehearsal scenarios. At the conclusion of the study, the investigators expect to be able to widely disseminate and market a new evidence-based primary prevention intervention for sexual violence for use in a variety of higher educational settings.
Read the detailed description
This proposal is designed to address the urgent need for an effective primary prevention approach to the problem of sexual violence among college students. It is estimated that 1 in every 5 college women has been sexually assaulted while in college. There is a dearth of primary prevention strategies that have demonstrated significant reductions in sexual violence in college students as part of a rigorously designed evaluation. Research shows that many victims of sexual assault are abused while drunk, under the influence of drugs, or otherwise incapacitated, and that incidents of sexual violence typically occur in college party settings where the victim knows the perpetrator and the perpetrator has been drinking or using drugs. In Phase I of this study, the investigators established the feasibility, relevance, and appeal of the new primary prevention program for sexual violence, alcohol, and drug abuse for incoming college students. The program is an adaptation of a successful evidence-based substance abuse and violence prevention approach called Life Skills Training (LST). The LST approach is designed to build personal self-management skills, social skills, and other life skills needed to reduce substance abuse and violence, increase resilience, and successfully navigate developmental tasks. In Phase I, the investigators developed the full scope and sequence of the program which outlines the learning objectives and activities of the of the online e-learning modules and small group facilitator-led sessions; developed relevant prototype materials to represent a subset of the full program; conducted formative research to establish the feasibility, relevance, and appeal of the intervention through a series of focus groups with college students and key informant interviews with college prevention staff; and recruited over 40 colleges and universities to participate in Phase II of the project. In Phase II, the investigators will fully develop the skills building curriculum materials and conduct a rigorous randomized controlled trial to examine the impact of the intervention. Forty colleges will be randomized into either an intervention group that will receive the new intervention or a treatment-as-usual control group that will receive the existing information on sexual violence provided at the school. At the end of a two-month intervention period, and at 6- and 12month follow-up assessments, the investigators will compare changes in behaviors, norms, attitudes, and knowledge regarding alcohol, drug abuse, and sexual violence. The ultimate intervention holds promise for wide dissemination as an evidence-based primary prevention approach for sexual violence to four-year colleges, community or junior colleges, universities, graduate and professional schools, for-profit schools, trade schools, and career and technical schools.
Phase II Specific Aims
- Fully develop the sexual violence primary prevention skills building curriculum materials;
- Conduct a randomized controlled trial to examine the impact of the intervention; randomize 40 colleges into either an intervention group that will receive the new intervention or a treatment-as-usual control group that will receive the existing information on sexual violence provided at the school;
- Conduct an outcome evaluation by assessing changes in the two experimental conditions with regards to behaviors, norms, attitudes, and knowledge regarding alcohol, drug abuse, and sexual violence at the end of the two-month intervention period, and at 6- and 12-month follow-up assessments;
- Conduct a process evaluation to document and monitor all Phase II project activities;
- Disseminate research findings to the scientific and practice communities;
- Create a provider training mechanism to promote dissemination and sustainability of the intervention;
- Based on the commercialization plan, implement a marketing strategy for the new primary prevention program aimed at institutions of higher education across the country.
- Conditions
- Sexual Violence, Substance Use, Substance Abuse
- Being tested
- LifeSkills Training for College
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeSkills Training for CollegeBehavioural
Also called LifeSkills Training, LST
The intervention will consist of e-learning modules (self-guided) and small-group sessions (facilitator led). The intervention is designed for new college students and is aimed at providing tools and strategies to help them maximize opportunities and adeptly handle the challenges ahead. The intervention will teach them the knowledge and skills needed to stay safe from problems that are prevalent among new students on college campuses, such as alcohol and drug abuse and sexual violence.
| Study group | Role | What they receive |
|---|---|---|
| LifeSkills Training for College | Experimental | All students who consent to participate in the proposed study will complete pre, post, six- and 12-month follow-up surveys. Those randomized to the intervention group (n=2000) will participate in the LST program adapted for college which consists of six 30-minute online sessions (content-specific instruction and skills building activities along with opportunities to apply newly acquired knowledge and practice new skills) and three 60-minute small groups sessions (facilitator-led sessions with fellow incoming students that complement the online modules). Receives: Behavioral: LifeSkills Training for College |
| Treatment as Usual (Control) | No intervention | All students who consent to participate in the proposed study will complete pre, post, six- and 12-month follow-up surveys. Those randomized to the control group (n=2000) will not participate in LST but will receive the sexual violence and substance abuse educational content normally provided by their schools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual violence behaviors, norms, and attitudes at baseline
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Measured: Pre-test (prior to participating in the first session/module of the intervention)
Change in baseline sexual violence behaviors, norms, and attitudes at post-intervention
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Measured: Post-test (within 2 weeks of completing final session/module of the intervention)
Change in baseline sexual violence behaviors, norms, and attitudes at 6-months
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Measured: 6-month followup (within 6-7 months of completing final session of intervention)
Change in baseline sexual violence behaviors, norms, and attitudes at 12-months
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Measured: 12-month followup (within 12-13 months of completing final session of intervention)
Secondary outcomes (4)
Substance use and abuse behaviors, norms, and attitudes at baseline
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Measured: Pre-test (prior to participating in the first session/module of the intervention)
Change in baseline substance use and abuse behaviors, norms, and attitudes at post-intervention
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Measured: Post-test (within 2 weeks of completing final session/module of the intervention)
Change in baseline substance use and abuse behaviors, norms, and attitudes at 6-months
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Measured: 6-month followup (within 6-7 months of completing final session of intervention)
Change in baseline substance use and abuse behaviors, norms, and attitudes at 12-months
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding alcohol and drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Measured: 12-month followup (within 12-13 months of completing final session of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startMay 2015
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual ViolenceStudies 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Promotion Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Kenneth W Griffin, National Health Promotion Associates, Inc.
- Investigators
- Kenneth W Griffin, PhD, Principal investigator, National Health Promotion Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037866
- Sponsor's protocol ID
- R44DA039602-01
- Status last verified
- Feb 2020
- First submitted
- 24 Jan 2017
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Sexual Violence Among College Students
- ClinicalTrials.gov ID
- NCT03037866
- Acronym / sponsor ID
- R44DA039602-01
- Conditions
- Sexual Violence, Substance Use, Substance Abuse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- National Health Promotion Associates, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 31 Jan 2017 (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.
This project is designed to address the urgent need for an effective primary prevention approach to the problem of sexual violence among college students. The project involves developing, feasibility testing, and testing for effectiveness an innovative new approach to the primary prevention of sexual violence, alcohol, and drug abuse among college students utilizing both online e-learning and small group facilitator-led intervention modalities. The intervention is an adaptation of the successful evidence-based substance abuse and violence prevention approach called Life Skills Training (LST). The adapted intervention is designed to address the relationship between sexual violence and substance abuse; positively change social norms surrounding alcohol/drug abuse and sexual violence; train bystanders to identify and appropriately respond to problematic situations; and build social, self-regulation, and relationship skills through interactive learning and behavioral rehearsal scenarios. At the conclusion of the study, the investigators expect to be able to widely disseminate and market a new evidence-based primary prevention intervention for sexual violence for use in a variety of higher educational settings.
Detailed description
This proposal is designed to address the urgent need for an effective primary prevention approach to the problem of sexual violence among college students. It is estimated that 1 in every 5 college women has been sexually assaulted while in college. There is a dearth of primary prevention strategies that have demonstrated significant reductions in sexual violence in college students as part of a rigorously designed evaluation. Research shows that many victims of sexual assault are abused while drunk, under the influence of drugs, or otherwise incapacitated, and that incidents of sexual violence typically occur in college party settings where the victim knows the perpetrator and the perpetrator has been drinking or using drugs. In Phase I of this study, the investigators established the feasibility, relevance, and appeal of the new primary prevention program for sexual violence, alcohol, and drug abuse for incoming college students. The program is an adaptation of a successful evidence-based substance abuse and violence prevention approach called Life Skills Training (LST). The LST approach is designed to build personal self-management skills, social skills, and other life skills needed to reduce substance abuse and violence, increase resilience, and successfully navigate developmental tasks. In Phase I, the investigators developed the full scope and sequence of the program which outlines the learning objectives and activities of the of the online e-learning modules and small group facilitator-led sessions; developed relevant prototype materials to represent a subset of the full program; conducted formative research to establish the feasibility, relevance, and appeal of the intervention through a series of focus groups with college students and key informant interviews with college prevention staff; and recruited over 40 colleges and universities to participate in Phase II of the project. In Phase II, the investigators will fully develop the skills building curriculum materials and conduct a rigorous randomized controlled trial to examine the impact of the intervention. Forty colleges will be randomized into either an intervention group that will receive the new intervention or a treatment-as-usual control group that will receive the existing information on sexual violence provided at the school. At the end of a two-month intervention period, and at 6- and 12month follow-up assessments, the investigators will compare changes in behaviors, norms, attitudes, and knowledge regarding alcohol, drug abuse, and sexual violence. The ultimate intervention holds promise for wide dissemination as an evidence-based primary prevention approach for sexual violence to four-year colleges, community or junior colleges, universities, graduate and professional schools, for-profit schools, trade schools, and career and technical schools.
Phase II Specific Aims
- Fully develop the sexual violence primary prevention skills building curriculum materials;
- Conduct a randomized controlled trial to examine the impact of the intervention; randomize 40 colleges into either an intervention group that will receive the new intervention or a treatment-as-usual control group that will receive the existing information on sexual violence provided at the school;
- Conduct an outcome evaluation by assessing changes in the two experimental conditions with regards to behaviors, norms, attitudes, and knowledge regarding alcohol, drug abuse, and sexual violence at the end of the two-month intervention period, and at 6- and 12-month follow-up assessments;
- Conduct a process evaluation to document and monitor all Phase II project activities;
- Disseminate research findings to the scientific and practice communities;
- Create a provider training mechanism to promote dissemination and sustainability of the intervention;
- Based on the commercialization plan, implement a marketing strategy for the new primary prevention program aimed at institutions of higher education across the country.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LifeSkills Training for College | Experimental | Behavioral: LifeSkills Training for CollegeAll students who consent to participate in the proposed study will complete pre, post, six- and 12-month follow-up surveys. Those randomized to the intervention group (n=2000) will participate in the LST program adapted for college which consists of six 30-minute online sessions (content-specific instruction and skills building activities along with opportunities to apply newly acquired knowledge and practice new skills) and three 60-minute small groups sessions (facilitator-led sessions with fellow incoming students that complement the online modules). |
| Treatment as Usual (Control) | No intervention | –All students who consent to participate in the proposed study will complete pre, post, six- and 12-month follow-up surveys. Those randomized to the control group (n=2000) will not participate in LST but will receive the sexual violence and substance abuse educational content normally provided by their schools. |
Who may qualify
- Ages
- 18 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- College students
Key exclusion criteria (2 listed)
- Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
- Any previous experience with the intervention program will also exclude adolescents from participating
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 |
|---|---|---|
| LifeSkills Training for CollegeAlso: LifeSkills Training, LSTThe intervention will consist of e-learning modules (self-guided) and small-group sessions (facilitator led). The intervention is designed for new college students and is aimed at providing tools and strategies to help them maximize opportunities and adeptly handle the challenges ahead. The intervention will teach them the knowledge and skills needed to stay safe from problems that are prevalent among new students on college campuses, such as alcohol and drug abuse and sexual violence. | Behavioural | LifeSkills Training for College |
Primary outcome
Sexual violence behaviors, norms, and attitudes at baseline
Time frame: Pre-test (prior to participating in the first session/module of the intervention)
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Change in baseline sexual violence behaviors, norms, and attitudes at post-intervention
Time frame: Post-test (within 2 weeks of completing final session/module of the intervention)
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Change in baseline sexual violence behaviors, norms, and attitudes at 6-months
Time frame: 6-month followup (within 6-7 months of completing final session of intervention)
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
Change in baseline sexual violence behaviors, norms, and attitudes at 12-months
Time frame: 12-month followup (within 12-13 months of completing final session of intervention)
The investigators will assess (via questionnaire) key study variables including behaviors, norms, attitudes, and knowledge regarding sexual violence and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group.
4 secondary outcomes
Substance use and abuse behaviors, norms, and attitudes at baseline
Time frame: Pre-test (prior to participating in the first session/module of the intervention)
Change in baseline substance use and abuse behaviors, norms, and attitudes at post-intervention
Time frame: Post-test (within 2 weeks of completing final session/module of the intervention)
Change in baseline substance use and abuse behaviors, norms, and attitudes at 6-months
Time frame: 6-month followup (within 6-7 months of completing final session of intervention)
Change in baseline substance use and abuse behaviors, norms, and attitudes at 12-months
Time frame: 12-month followup (within 12-13 months of completing final session of intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Sexual Violence
Active, not recruiting
What Works to Prevent Violence Against Women and Girls in Madagascar
Comprehensive Sexual Education
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
RecruitingPhase 2
Study of Cross-Cutting E-Health Prevention Approaches
Alcohol Misuse Prevention, Sexual Violence Prevention
Enrolling by invitation
The Effectiveness of a Brief Early Intervention of Acute Stress Syndrome Stabilization Protocol for Victims of Sexual Violence (ASSYST-SV).
Acute Stress Symptoms, Sexual Violence
Recruiting
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
Substance Abuse, Intimate Partner Violence (IPV)
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.
Kenneth W Griffin, PhD principal investigator
National Health Promotion Associates, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing LifeSkills Training for College in people with Sexual Violence and Substance Use, run by National Health Promotion Associates, Inc..
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: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Sexual violence behaviors, norms, and attitudes at baseline (time frame: Pre-test (prior to participating in the first session/module of the intervention)). The study lists 4 primary outcomes in all. 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 25 Feb 2020.