NCT03928067

Brief Online Study Abroad Alcohol Intervention

Status unknown NA Last updated 17 August 2021

What this trial tests

NA trial testing PNF + SAF in Alcohol Abuse in 1,200 participants. Status unknown.

Timeline

23 May 2019

Primary endpoint
30 March 2021

30 June 2022

Quick facts

Lead sponsor	RAND
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,200
Start date	23 May 2019
Primary completion	30 March 2021
Estimated completion	30 June 2022
Sites	1 location across United States

Drugs / interventions tested

• PNF + SAF

Conditions studied

• Alcohol Abuse — all drugs for Alcohol Abuse →

Sponsor

RAND — full company profile →

Who can join

Adults 18 to 25, any sex, with Alcohol Abuse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. An online alcohol and risky sex prevention program for college students studying abroad: study protocol for a randomized controlled trial.
   Pedersen ER, D'Amico EJ, LaBrie JW, Farris C, et al · · 2019 · cited 12× · PMID 31429802 · DOI 10.1186/s13722-019-0162-4
2. A randomized controlled trial of an online alcohol and sexual risk prevention program for college students studying abroad.
   Pedersen ER, D'Amico EJ, LaBrie JW, Klein DJ, et al · · 2023 · cited 1× · PMID 36880917 · DOI 10.1016/j.josat.2023.208951