Brief Online Study Abroad Alcohol Intervention

Alcohol Abuse Clinical Trial

Official title:

Online Intervention to Prevent Risky Behaviors During College Student Study Abroad Experiences

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03928067
• Other study ID #: R01AA025909
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 23, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2021
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2022
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism

Intervention

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

Locations

Country	Name	City	State
United States	RAND	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
RAND	Loyola Marymount University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drinks per week	Total drinks per week in the past 30 days	Past month (30 days)
Primary	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)
Primary	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)
Primary	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)
Primary	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