Alcohol DrinkingNCT02983864
Group Alcohol Interventions for College Men
A study testing BASICS, Integrated BASICS and Relaxation in people with Alcohol Drinking and Sexual Behavior, run by Ohio University.
Trial summary
The objective of the proposed project is to conduct a randomized controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention only to men who receive a group integrated alcohol and sexual assault… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Alcohol Drinking, Sexual Behavior
- What is being tested?
- BASICS, Integrated BASICS and Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Nov 2019
- 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 years and older
- Men only
- No healthy volunteers
- 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
About this study
Official title: Examining an Integrated Bystander and Alcohol Program for Sexual Assault Perpetration: A Preliminary Randomized Controlled Trial
The objective of the proposed project is to conduct a randomized controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention only to men who receive a group integrated alcohol and sexual assault intervention.
Read the detailed description
Although research suggests that sexual assault interventions based on Bystander and Social Norms theory help to reduce sexual assault among college men, these programs do not completely eliminate sexual assault and their effects tend to fade over time. Unfortunately, there is minimal research on whether (1) decreasing alcohol use concurrently decreases sexual assault perpetration among college men and (2) whether alcohol interventions can be incorporated into existing sexual assault programs for college men (i.e., Bystander/Social Norms programs). Therefore, the objective of the proposed project is to conduct a randomized controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention only to men who receive a group integrated alcohol and sexual assault intervention. Specifically, the alcohol only intervention will consist of the Brief Alcohol Screening and Intervention for College Students (BASICS), an empirically-supported intervention for college student drinking. The integrated alcohol and sexual assault intervention, which we have termed Ohio University's Combined Alcohol and Normative Intervention program (OU CAN), will be modeled after BASICS and empirically-supported Bystander and Social Norms interventions for sexual assault. The current study will recruit 100 college men who are sanctioned by their university to receive an alcohol intervention for violating a campus alcohol policy: by definition an indicated and at-risk population for sexual assault perpetration. Men will be followed for 6 months to determine the effects of the intervention on sexual assault perpetration and other primary outcomes (e.g., bystander behavior).
- Conditions
- Alcohol Drinking, Sexual Behavior
- Being tested
- BASICS, Integrated BASICS, Relaxation, Integrated Bystander
- Medical subject headings
- Alcohol Drinking, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASICSBehavioural
A one session intervention focused on reducing drinking with motivational interviewing
Integrated BASICSBehavioural
A one session intervention focused on reducing drinking and sexual behavior while drinking
RelaxationBehavioural
A one session intervention focused on increasing relaxation skills
Integrated BystanderBehavioural
A one session intervention focused on reducing sexual assault with a focus on the role of alcohol
| Study group | Role | What they receive |
|---|---|---|
| Alcohol and Relaxation | Active comparator | This arm will receive a brief (2-hour) alcohol intervention based on motivational interviewing termed BASICS and a brief (1.5 hour) relaxation intervention Receives: Behavioral: BASICS; Behavioral: Relaxation |
| Alcohol and Relationships | Active comparator | This arm will receive a brief (4-hour), two session, integrated alcohol and relationship intervention based on motivational interviewing designed to increase healthy alcohol use and sexual behavior. The interventions are based on an integrated BASICS and integrated Bystander protocols Receives: Behavioral: Integrated BASICS; Behavioral: Integrated Bystander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Experiences Survey
A self-report measure that examines potential sexual assault behaviors
Measured: 6 months post-intervention
Secondary outcomes (5)
Bystander Behavior Scale
A self-report measure that examines opportunities and engagement in prosocial bystander behavior.
Measured: 6 months post-intervention
Illinois Rape Myth Acceptance Scale
A self-report measure that examines rape supportive beliefs
Measured: 6 months post-intervention
Sexual Social Norms Inventory
A self-report measure that examines sexual normative beliefs
Measured: 6 months post-intervention
Alcohol use Disorders Identification Test
A self-report measure that examines alcohol use
Measured: 6 months post-intervention
Comprehensive Effects of Alcohol
A self-report measure that examines expectancies of alcohol use
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 posted6 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionNov 2019
- Study completionNov 2019
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Justice
- Responsible party
- Sponsor
- Investigators
- Brian T Wymbs, PhD, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983864
- Sponsor's protocol ID
- 16-F-33
- Status last verified
- Mar 2020
- First submitted
- 1 Dec 2016
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining an Integrated Bystander and Alcohol Program for Sexual Assault Perpetration: A Preliminary Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02983864
- Acronym / sponsor ID
- 16-F-33
- Conditions
- Alcohol Drinking, Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- U.S. Department of Justice
- Study start
- Jan 2017
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 6 Dec 2016 (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 objective of the proposed project is to conduct a randomized controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention only to men who receive a group integrated alcohol and sexual assault intervention.
Detailed description
Although research suggests that sexual assault interventions based on Bystander and Social Norms theory help to reduce sexual assault among college men, these programs do not completely eliminate sexual assault and their effects tend to fade over time. Unfortunately, there is minimal research on whether (1) decreasing alcohol use concurrently decreases sexual assault perpetration among college men and (2) whether alcohol interventions can be incorporated into existing sexual assault programs for college men (i.e., Bystander/Social Norms programs). Therefore, the objective of the proposed project is to conduct a randomized controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention only to men who receive a group integrated alcohol and sexual assault intervention. Specifically, the alcohol only intervention will consist of the Brief Alcohol Screening and Intervention for College Students (BASICS), an empirically-supported intervention for college student drinking. The integrated alcohol and sexual assault intervention, which we have termed Ohio University's Combined Alcohol and Normative Intervention program (OU CAN), will be modeled after BASICS and empirically-supported Bystander and Social Norms interventions for sexual assault. The current study will recruit 100 college men who are sanctioned by their university to receive an alcohol intervention for violating a campus alcohol policy: by definition an indicated and at-risk population for sexual assault perpetration. Men will be followed for 6 months to determine the effects of the intervention on sexual assault perpetration and other primary outcomes (e.g., bystander behavior).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol and Relaxation | Active comparator | Behavioral: BASICS, Behavioral: RelaxationThis arm will receive a brief (2-hour) alcohol intervention based on motivational interviewing termed BASICS and a brief (1.5 hour) relaxation intervention |
| Alcohol and Relationships | Active comparator | Behavioral: Integrated BASICS, Behavioral: Integrated BystanderThis arm will receive a brief (4-hour), two session, integrated alcohol and relationship intervention based on motivational interviewing designed to increase healthy alcohol use and sexual behavior. The interventions are based on an integrated BASICS and integrated Bystander protocols |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not 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
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 one session intervention focused on reducing drinking with motivational interviewing | Behavioural | Alcohol and Relaxation |
| Integrated BASICSA one session intervention focused on reducing drinking and sexual behavior while drinking | Behavioural | Alcohol and Relationships |
| RelaxationA one session intervention focused on increasing relaxation skills | Behavioural | Alcohol and Relaxation |
| Integrated BystanderA one session intervention focused on reducing sexual assault with a focus on the role of alcohol | Behavioural | Alcohol and Relationships |
Primary outcome
Sexual Experiences Survey
Time frame: 6 months post-intervention
A self-report measure that examines potential sexual assault behaviors
5 secondary outcomes
Bystander Behavior Scale
Time frame: 6 months post-intervention
Illinois Rape Myth Acceptance Scale
Time frame: 6 months post-intervention
Sexual Social Norms Inventory
Time frame: 6 months post-intervention
Alcohol use Disorders Identification Test
Time frame: 6 months post-intervention
Comprehensive Effects of Alcohol
Time frame: 6 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Brian T Wymbs, PhD principal investigator
Ohio University
Questions about this trial
What is this clinical trial studying?
A study testing BASICS, Integrated BASICS and Relaxation in people with Alcohol Drinking and Sexual Behavior, 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: finished, as of the sponsor's last update on 5 Mar 2020. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sexual Experiences Survey (time frame: 6 months post-intervention). 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 5 Mar 2020.