Primary Prevention of Sexual Violence Among College Students

NCT03037866 | Unknown DMC

• 1 other identifier: R44DA039602-01
• Study Type: interventional
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sexual Violence; Substance Use; Substance Abuse

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (4)

• Substance use and abuse behaviors, norms, and attitudes at baseline

  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

  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

  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

  12-month followup (within 12-13 months of completing final session of intervention)

Study Arms (2)

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).

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.

Interventions

LifeSkills Training for College BEHAVIORAL

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.

Also known as: LifeSkills Training, LST

LifeSkills Training for College

Eligibility Criteria

• Age: 18 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• College students

You may not qualify if:

• 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

Sponsors & Collaborators

• National Health Promotion Associates, Inc.: lead

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kenneth W Griffin, PhD

  National Health Promotion Associates, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 31, 2017
• Study Start: May 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share