Primary Prevention of Sexual Violence Among College Students

Substance Abuse Clinical Trial

Official title:

Primary Prevention of Sexual Violence Among College Students

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03037866
• Other study ID #: R44DA039602-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2015
• Est. completion date: June 2020

Study information

• Verified date: February 2020
• Source: National Health Promotion Associates, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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

1. Fully develop the sexual violence primary prevention skills building curriculum materials;

2. 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;

3. 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;

4. Conduct a process evaluation to document and monitor all Phase II project activities;

5. Disseminate research findings to the scientific and practice communities;

6. Create a provider training mechanism to promote dissemination and sustainability of the intervention;

7. Based on the commercialization plan, implement a marketing strategy for the new primary prevention program aimed at institutions of higher education across the country.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4000
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 20 Years

Eligibility

Inclusion Criteria:

• College students

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Sexual Violence
• Substance Abuse
• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• LifeSkills Training for College
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Health Promotion Associates, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-test (prior to participating in the first session/module of the intervention)
Primary	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.	Post-test (within 2 weeks of completing final session/module of the intervention)
Primary	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.	6-month followup (within 6-7 months of completing final session of intervention)
Primary	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.	12-month followup (within 12-13 months of completing final session of intervention)
Secondary	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.	Pre-test (prior to participating in the first session/module of the intervention)
Secondary	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.	Post-test (within 2 weeks of completing final session/module of the intervention)
Secondary	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.	6-month followup (within 6-7 months of completing final session of intervention)
Secondary	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.	12-month followup (within 12-13 months of completing final session of intervention)