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Brief Online Study Abroad Alcohol Intervention

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ClinicalTrials.gov Identifier: NCT03928067
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
Loyola Marymount University
Information provided by (Responsible Party):
RAND

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.


Condition or disease Intervention/treatment Phase
Alcohol Abuse Behavioral: PNF + SAF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Masking of participants not possible
Primary Purpose: Prevention
Official Title: Online Intervention to Prevent Risky Behaviors During College Student Study Abroad Experiences
Actual Study Start Date : May 23, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: TREK Study Abroad Program
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.
Behavioral: PNF + SAF
Personalized normative feedback (PNF) to correct misperceived peer drinking norms abroad + sojourner adjustment feedback (SAF) to promote cultural engagement abroad.
Other Name: TREK

No Intervention: Control
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.



Primary Outcome Measures :
  1. Drinks per week [ Time Frame: Past month (30 days) ]
    Total drinks per week in the past 30 days

  2. Binge drinking frequency [ Time Frame: Past month (30 days) ]
    Frequency of binge drinking (5+ drinks on one occasion for males; 4+ drinks on one occasion for females)

  3. Alcohol-related consequences [ Time Frame: Past month (30 days) ]
    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)

  4. Risky sexual behaviors [ Time Frame: Past month (30 days) ]
    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).

  5. Sexual violence victimization [ 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 ]
    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



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928067


Contacts
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Contact: Eric R Pedersen, Ph.D. 310-393-0411 ext 6078 ericp@rand.org

Locations
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United States, California
RAND Recruiting
Santa Monica, California, United States, 90407
Contact: Eric R Pedersen, PhD    310-393-0411 ext 6078    ericp@rand.org   
Principal Investigator: Eric R Pedersen, PhD         
Sponsors and Collaborators
RAND
Loyola Marymount University

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Responsible Party: RAND
ClinicalTrials.gov Identifier: NCT03928067     History of Changes
Other Study ID Numbers: R01AA025909 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RAND:
alcohol
sexual violence
risky sex
college students

Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders