Alcohol DrinkingPhase 2NCT02603978
Interventions for Sanctioned Ohio University Students
A Phase 2 study testing BASICS, Bystander and Social Norms and Combined BASICS and Bystander in people with Alcohol Drinking, run by Ohio University.
Trial summary
The purpose of this study is to determine whether (a) a brief alcohol intervention, (b) a brief bystander and social norms intervention, or (c) a brief alcohol and a brief bystander and social norms intervention are effective at reducing alcohol use and sexual-related behaviors among college men mandated to receive an… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- BASICS, Bystander and Social Norms and Combined BASICS and Bystander
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jun 2019
- Phase
- Phase 2
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be 18 or older; must be an ohio university student; must be male; must be sanctioned to receive an alcohol intervention by Ohio University
Who cannot join
- Under the age of 18; not attending the main Ohio University campus (Athens)
About this study
Official title: Examining the Efficacy of Interventions for Sexual Assault: A Preliminary Randomized Controlled Trial
The purpose of this study is to determine whether (a) a brief alcohol intervention, (b) a brief bystander and social norms intervention, or (c) a brief alcohol and a brief bystander and social norms intervention are effective at reducing alcohol use and sexual-related behaviors among college men mandated to receive an alcohol intervention by their university.
- Conditions
- Alcohol Drinking
- Being tested
- BASICS, Bystander and Social Norms, Combined BASICS and Bystander
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASICSBehavioural
A 2-hour group intervention focused on reducing alcohol use with the use of motivational interviewing
Bystander and Social NormsBehavioural
A 2-hour group intervention focused on increasing healthy sexual behaviors and prosocial bystander behavior
Combined BASICS and BystanderBehavioural
A 2-session, 4-hour group that consists of both BASICS and the Bystander intervention
| Study group | Role | What they receive |
|---|---|---|
| Wait-list | No intervention | This arm will receive no intervention for the first 6 months. At the conclusion of the 6-month period, this group will receive a brief alcohol intervention |
| Brief Alcohol Intervention | Active comparator | This arm will receive a brief (2-hour) alcohol intervention based on motivational interviewing Receives: Behavioral: BASICS |
| Bystander and Social Norms Intervention | Active comparator | This arm will receive a brief (2-hour) bystander and social norms intervention designed to increase healthy sexual behaviors Receives: Behavioral: Bystander and Social Norms |
| Combined Alcohol and Bystander Intervention | Active comparator | This arm will receive a combined (4-hour) alcohol and bystander/social norms intervention to target both alcohol and sexual behavior Receives: Behavioral: Combined BASICS and Bystander |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Alcohol Use Disorders Identification Test
A self-report measure that examines alcohol use and problems. This measure produces one total score that is interpreted as "alcohol use and problems."
Measured: 6 months post-intervention
Bystander Behavior Scale
A self-report measure that examines opportunities and engagement in prosocial bystander behavior. A single total score is obtained by calculating the percentage of times individuals engaged in bystander behavior based on the number of opportunities they had for such behavior.
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation
- Responsible party
- Principal investigator, Ryan Shorey, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603978
- Sponsor's protocol ID
- 15F018
- Status last verified
- Sep 2017
- First submitted
- 6 Nov 2015
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of Interventions for Sexual Assault: A Preliminary Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02603978
- Acronym / sponsor ID
- 15F018
- Conditions
- Alcohol Drinking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- American Psychological Foundation
- Study start
- Aug 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 13 Nov 2015 (estimated)
- 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.
The purpose of this study is to determine whether (a) a brief alcohol intervention, (b) a brief bystander and social norms intervention, or (c) a brief alcohol and a brief bystander and social norms intervention are effective at reducing alcohol use and sexual-related behaviors among college men mandated to receive an alcohol intervention by their university.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Wait-list | No intervention | –This arm will receive no intervention for the first 6 months. At the conclusion of the 6-month period, this group will receive a brief alcohol intervention |
| Brief Alcohol Intervention | Active comparator | Behavioral: BASICSThis arm will receive a brief (2-hour) alcohol intervention based on motivational interviewing |
| Bystander and Social Norms Intervention | Active comparator | Behavioral: Bystander and Social NormsThis arm will receive a brief (2-hour) bystander and social norms intervention designed to increase healthy sexual behaviors |
| Combined Alcohol and Bystander Intervention | Active comparator | Behavioral: Combined BASICS and BystanderThis arm will receive a combined (4-hour) alcohol and bystander/social norms intervention to target both alcohol and sexual behavior |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be 18 or older; must be an ohio university student; must be male; must be sanctioned to receive an alcohol intervention by Ohio University
Key exclusion criteria (1 listed)
- Under the age of 18; not attending the main Ohio University campus (Athens)
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 |
|---|---|---|
| BASICSA 2-hour group intervention focused on reducing alcohol use with the use of motivational interviewing | Behavioural | Brief Alcohol Intervention |
| Bystander and Social NormsA 2-hour group intervention focused on increasing healthy sexual behaviors and prosocial bystander behavior | Behavioural | Bystander and Social Norms Intervention |
| Combined BASICS and BystanderA 2-session, 4-hour group that consists of both BASICS and the Bystander intervention | Behavioural | Combined Alcohol and Bystander Intervention |
Primary outcome
The Alcohol Use Disorders Identification Test
Time frame: 6 months post-intervention
A self-report measure that examines alcohol use and problems. This measure produces one total score that is interpreted as "alcohol use and problems."
Bystander Behavior Scale
Time frame: 6 months post-intervention
A self-report measure that examines opportunities and engagement in prosocial bystander behavior. A single total score is obtained by calculating the percentage of times individuals engaged in bystander behavior based on the number of opportunities they had for such behavior.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BASICS, Bystander and Social Norms and Combined BASICS and Bystander in people with Alcohol Drinking, run by Ohio University.
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 1 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 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The Alcohol Use Disorders Identification Test (time frame: 6 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2017.