NCT03928067

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

May 23, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

April 22, 2019

Last Update Submit

August 15, 2021

Conditions

Keywords

alcoholsexual violencerisky sexcollege students

Outcome Measures

Primary Outcomes (5)

  • Drinks per week

    Total drinks per week in the past 30 days

    Past month (30 days)

  • Binge drinking frequency

    Frequency of binge drinking (5+ drinks on one occasion for males; 4+ drinks on one occasion for females)

    Past month (30 days)

  • 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)

    Past month (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).

    Past month (30 days)

  • 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

    Change in any sexual violence victimization experiences from before study abroad trip through the three months following the completion of the study abroad trip

Study Arms (2)

TREK Study Abroad Program

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

PNF + SAFBEHAVIORAL

Personalized normative feedback (PNF) to correct misperceived peer drinking norms abroad + sojourner adjustment feedback (SAF) to promote cultural engagement abroad.

Also known as: TREK
TREK Study Abroad Program

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • None except not meeting eligibility criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAND

Santa Monica, California, 90407, United States

Location

Related Publications (2)

  • Pedersen ER, D'Amico EJ, LaBrie JW, Klein DJ, Farris C, Griffin BA. A randomized controlled trial of an online alcohol and sexual risk prevention program for college students studying abroad. J Subst Use Addict Treat. 2023 Feb;145:208951. doi: 10.1016/j.josat.2023.208951. Epub 2023 Jan 13.

  • 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.

MeSH Terms

Conditions

Alcoholism

Interventions

Syntex adjuvant formulation

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking of participants not possible
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 25, 2019

Study Start

May 23, 2019

Primary Completion

March 30, 2021

Study Completion

June 30, 2022

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations