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Brief Online Study Abroad Alcohol Intervention

Primary Purpose

Alcohol Abuse

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PNF + SAF
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Abuse focused on measuring alcohol, sexual violence, risky sex, college students

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between the ages of 18 and 25
  • Signed up to study abroad in one of the 12 most popular destinations (i.e., United Kingdom, Italy, Spain, France, Germany, China, Ireland, Australia, Costa Rica, Japan, South Africa, and Mexico
  • Plan to study abroad for between 8 and 21 weeks (approximately one quarter/semester)
  • Have a working email address

Exclusion Criteria:

  • None except not meeting eligibility criteria

Sites / Locations

  • RAND

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TREK Study Abroad Program

Control

Arm Description

On-screen personalized normative feedback (PNF) will contain information on the drinking behavior and attitudes about gender- and country-specific study abroad peers. Participants will view text-based tips and strategies and watch clips of prior student abroad students discussing how they met their cultural engagement goals while abroad (Sojourner Adjustment Feedback or SAF). Content focuses around the four aspects of positive sojourner adjustment (social interaction with host nationals, cultural understanding and participation, language development and use, host culture identification) and the two negative sojourner adjustment factors while abroad (i.e., social interaction with co-nationals, homesickness/feeling out of place). The intervention will also contain text- and video-based tips and strategies for protective strategies used abroad to limit experience of risk sex and sexual violence victimization.

Control participants will receive a link to a general website offering study abroad advice (www.studyabroad.com) and will be asked to spend at least 20 to 30 minutes reviewing their institution's study abroad website content, including policies for drinking abroad. This control condition was selected as a form of "treatment as usual" as our conversations with study abroad personnel indicate this is the extent of typical information students receive about alcohol use abroad.

Outcomes

Primary Outcome Measures

Drinks per week
Total drinks per week in the past 30 days
Binge drinking frequency
Frequency of binge drinking (5+ drinks on one occasion for males; 4+ drinks on one occasion for females)
Alcohol-related consequences
24-item Brief Young Adult Alcohol Consequences Questionnaire, a measure of negative consequences often used with the college population. The scale contains 24 yes/no items that when summed gives a score from 0 to 24 (score of 24 indicates experience of all 24 alcohol consequences in the past 30 days)
Risky sexual behaviors
Sexual Risk Survey, a 23-item measure designed for and validated with college student samples. The scale yields an overall sexual risk behaviors score based on responses to the 23 items. The scale allows for open-ended responses that are then recoded into ordinal categories for generating an overall score from 0 to 92 (higher scores = higher risk).
Sexual violence victimization
A scale to assess any sexual violence victimization was created from items modified and informed by items from the Sexual Experiences Survey and the National Drug-Facilitated, Incapacitated, and Forcible Rape study. The items are gender-specific (i.e., separate wording of items for those that identify as men, women, and gender-neutral) and contains 12 items with a yes/no format. Endorsement of any yes response yields an affirmative response to the outcome of experience of any sexual violence

Secondary Outcome Measures

Full Information

First Posted
April 22, 2019
Last Updated
August 15, 2021
Sponsor
RAND
Collaborators
Loyola Marymount University
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1. Study Identification

Unique Protocol Identification Number
NCT03928067
Brief Title
Brief Online Study Abroad Alcohol Intervention
Official Title
Online Intervention to Prevent Risky Behaviors During College Student Study Abroad Experiences
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
Loyola Marymount University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study involves a randomized controlled trial that builds upon a successful pilot intervention study to address problematic and dangerous drinking among young adult college students studying abroad in foreign environments. Despite universities and colleges citing alcohol misuse as the most concerning issue for their students abroad, most institutions offer no empirically-based prevention efforts tailored to this at-risk population. The proposed intervention attempts to fill a major gap for the nearly 333,000 students completing study abroad programs each year by addressing empirically-based and theoretically-informed risk and protective factors of correcting misperceived peer drinking norms and promoting cultural engagement abroad. In addition to preventing heavy and problematic drinking, the intervention seeks to prevent risky behaviors and experience of sexual violence victimization, which are strikingly common among study abroad students and have the potential for lasting physical and psychological effects upon return home. The investigators will conduct a randomized controlled trial of a developed intervention with a sample of 1,200 college students studying abroad from 35 U.S. universities and colleges. The brief, online intervention is text and video based and contains evidence-based components of personalized normative feedback to correct students' misperceived drinking norms, content to promote engagement with the cultural experience abroad and addressed difficulties adjusting to life in the foreign environment, and tips and strategies to prevent risky sexual behaviors and sexual violence victimization abroad. Participants will complete online surveys at five time points (predeparture, first month abroad, last month abroad, one-month post-return, and three-months post-return) to assess for intervention effects on drinking, risky sex, and sexual violence outcomes. The investigators will examine whether the mechanisms targeted by the intervention (changes in perceived norms, engagement in the cultural experience abroad) serve as mediators of intervention efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
alcohol, sexual violence, risky sex, college students

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Masking of participants not possible
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TREK Study Abroad Program
Arm Type
Experimental
Arm Description
On-screen personalized normative feedback (PNF) will contain information on the drinking behavior and attitudes about gender- and country-specific study abroad peers. Participants will view text-based tips and strategies and watch clips of prior student abroad students discussing how they met their cultural engagement goals while abroad (Sojourner Adjustment Feedback or SAF). Content focuses around the four aspects of positive sojourner adjustment (social interaction with host nationals, cultural understanding and participation, language development and use, host culture identification) and the two negative sojourner adjustment factors while abroad (i.e., social interaction with co-nationals, homesickness/feeling out of place). The intervention will also contain text- and video-based tips and strategies for protective strategies used abroad to limit experience of risk sex and sexual violence victimization.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control participants will receive a link to a general website offering study abroad advice (www.studyabroad.com) and will be asked to spend at least 20 to 30 minutes reviewing their institution's study abroad website content, including policies for drinking abroad. This control condition was selected as a form of "treatment as usual" as our conversations with study abroad personnel indicate this is the extent of typical information students receive about alcohol use abroad.
Intervention Type
Behavioral
Intervention Name(s)
PNF + SAF
Other Intervention Name(s)
TREK
Intervention Description
Personalized normative feedback (PNF) to correct misperceived peer drinking norms abroad + sojourner adjustment feedback (SAF) to promote cultural engagement abroad.
Primary Outcome Measure Information:
Title
Drinks per week
Description
Total drinks per week in the past 30 days
Time Frame
Past month (30 days)
Title
Binge drinking frequency
Description
Frequency of binge drinking (5+ drinks on one occasion for males; 4+ drinks on one occasion for females)
Time Frame
Past month (30 days)
Title
Alcohol-related consequences
Description
24-item Brief Young Adult Alcohol Consequences Questionnaire, a measure of negative consequences often used with the college population. The scale contains 24 yes/no items that when summed gives a score from 0 to 24 (score of 24 indicates experience of all 24 alcohol consequences in the past 30 days)
Time Frame
Past month (30 days)
Title
Risky sexual behaviors
Description
Sexual Risk Survey, a 23-item measure designed for and validated with college student samples. The scale yields an overall sexual risk behaviors score based on responses to the 23 items. The scale allows for open-ended responses that are then recoded into ordinal categories for generating an overall score from 0 to 92 (higher scores = higher risk).
Time Frame
Past month (30 days)
Title
Sexual violence victimization
Description
A scale to assess any sexual violence victimization was created from items modified and informed by items from the Sexual Experiences Survey and the National Drug-Facilitated, Incapacitated, and Forcible Rape study. The items are gender-specific (i.e., separate wording of items for those that identify as men, women, and gender-neutral) and contains 12 items with a yes/no format. Endorsement of any yes response yields an affirmative response to the outcome of experience of any sexual violence
Time Frame
Change in any sexual violence victimization experiences from before study abroad trip through the three months following the completion of the study abroad trip

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between the ages of 18 and 25 Signed up to study abroad in one of the 12 most popular destinations (i.e., United Kingdom, Italy, Spain, France, Germany, China, Ireland, Australia, Costa Rica, Japan, South Africa, and Mexico Plan to study abroad for between 8 and 21 weeks (approximately one quarter/semester) Have a working email address Exclusion Criteria: None except not meeting eligibility criteria
Facility Information:
Facility Name
RAND
City
Santa Monica
State/Province
California
ZIP/Postal Code
90407
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31429802
Citation
Pedersen ER, D'Amico EJ, LaBrie JW, Farris C, Klein DJ, Griffin BA. An online alcohol and risky sex prevention program for college students studying abroad: study protocol for a randomized controlled trial. Addict Sci Clin Pract. 2019 Aug 20;14(1):32. doi: 10.1186/s13722-019-0162-4.
Results Reference
derived

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Brief Online Study Abroad Alcohol Intervention

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