Alcohol AbuseNCT03928067
Brief Online Study Abroad Alcohol Intervention
A study testing PNF + SAF in people with Alcohol Abuse, run by RAND at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Abuse
- What is being tested?
- PNF + SAF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- None except not meeting eligibility criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Online Intervention to Prevent Risky Behaviors During College Student Study Abroad Experiences
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.
- Conditions
- Alcohol Abuse
- Being tested
- PNF + SAF
- Keywords
- alcohol, sexual violence, risky sex, college students
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF + SAFBehavioural
Also called TREK
Personalized normative feedback (PNF) to correct misperceived peer drinking norms abroad + sojourner adjustment feedback (SAF) to promote cultural engagement abroad.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinks per week
Total drinks per week in the past 30 days
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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
Measured: Change in any sexual violence victimization experiences from before study abroad trip through the three months following the completion of the study abroad trip
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start23 May 2019
- Primary completion30 Mar 2021
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola Marymount University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928067
- Sponsor's protocol ID
- R01AA025909
- Status last verified
- Aug 2021
- First submitted
- 22 Apr 2019
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36880917Pedersen 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.
PubMed 31429802
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Intervention to Prevent Risky Behaviors During College Student Study Abroad Experiences
- ClinicalTrials.gov ID
- NCT03928067
- Acronym / sponsor ID
- R01AA025909
- Conditions
- Alcohol Abuse
- Keywords
- alcohol, sexual violence, risky sex, college students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- Loyola Marymount University
- Study start
- 23 May 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TREK Study Abroad Program | Experimental | Behavioral: PNF + SAFOn-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 | 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None except not meeting eligibility criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNF + SAFAlso: TREKPersonalized normative feedback (PNF) to correct misperceived peer drinking norms abroad + sojourner adjustment feedback (SAF) to promote cultural engagement abroad. | Behavioural | TREK Study Abroad Program |
Primary outcome
Drinks per week
Time frame: Past month (30 days)
Total drinks per week in the past 30 days
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)
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)
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).
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Derived from this study: PubMed 36880917Pedersen 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.
- Derived from this study: PubMed 31429802Pedersen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF + SAF in people with Alcohol Abuse, run by RAND at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinks per week (time frame: Past month (30 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03928067, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.