Alcohol DrinkingNCT05773027
Integrated Alcohol and Sexual Assault Intervention for College Men
A study testing SAFE in people with Alcohol Drinking and Sexual Assault, run by Lifespan at 1 site in United States.
Trial summary
This research will evaluate a new intervention that integrates evidence-based alcohol intervention strategies and promising sexual assault prevention strategies with the goal of decreasing sexual aggression among men who report heavy drinking; a particularly high risk group. Read more about this study
- Who is it for?
- Ages 18 to 22 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Sexual Assault
- What is being tested?
- SAFE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2013to 13 Dec 2017
- 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 22 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Engaging in binge drinking, defined as 5 or more drinks per day for men on the same occasion by the Substance Abuse and Mental Health Services Administration on two or more occasions in the past month.
- Engaging in oral, vaginal, or anal sexual intercourse with a female partner one or more times in the past four months
Who cannot join
- Displaying symptoms consistent with alcohol use withdrawal
- Reporting current suicidal or homicidal ideation
- Meeting criteria consistent with a diagnosis of Antisocial Personality Disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02904
About this study
This research will evaluate a new intervention that integrates evidence-based alcohol intervention strategies and promising sexual assault prevention strategies with the goal of decreasing sexual aggression among men who report heavy drinking; a particularly high risk group. Specifically, this study will conduct a randomized controlled pilot trial with college men who report heavy drinking to demonstrate the feasibility and acceptability of the proposed intervention. The main questions the study will answer are: 1) what is the feasibility of the recruitment plans, research design, intervention training methods, and delivery of the program?; and 2) does the intervention, relative to a mindfulness-based control condition, produce reductions in the quantity and frequency of alcohol use, perpetration of sexual aggression, and attitudes associated with sexual aggression over the 2- and 6-month follow-up. Follow-up assessments are completed at 2- and 6-months following the program. The intervention is compared to the mindfulness-based control group.
- Conditions
- Alcohol Drinking, Sexual Assault
- Being tested
- SAFE, Mindfulness-Based Control Condition
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFEBehavioural
SAFE includes a motivational interviewing session addressing alcohol use and risk for sexual aggression, a workshop addressing alcohol use and sexual aggression, and a booster session review.
Mindfulness-Based Control ConditionBehavioural
The program includes the same amount of contacts as SAFE, including an individual session focused on mindfulness and stress, a group session, and a booster session review.
| Study group | Role | What they receive |
|---|---|---|
| Sexual Assault and Alcohol Feedback and Education (SAFE) | Experimental | SAFE includes a motivational interviewing session addressing alcohol use and risk for sexual aggression, a workshop addressing alcohol use and sexual aggression, and a booster session review. Receives: Behavioral: SAFE |
| Mindfulness-Based Control Condition | Active comparator | The program includes the same amount of contacts as SAFE, including an individual session focused on mindfulness and stress, a group session, and a booster session review. Receives: Behavioral: Mindfulness-Based Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use, heavy drinking quantity
Number of heavy drinking days in the past month (Minimum = 0, Maximum = 31), assessed via the timeline follow-back. Greater scores mean worse outcomes.
Measured: Change from baseline alcohol use at 6 months.
Alcohol use, drinks per week
The average number of drinks per week (Minimum = 0, Maximum = unspecified), assessed via the timeline follow-back. Greater scores mean worse outcomes.
Measured: Change from baseline alcohol use at 6 months.
Sexual aggression perpetration
Assessed via the sexual experiences survey. Scored based on frequency and severity (Minimum = 0, Maximum = 63). Higher scores mean worse outcomes.
Measured: Change in severity and frequency in comparison to control at 6-months.
Secondary outcomes (11)
Protective behavioral strategies
Assessed via the Self Control Questionnaire (Minimum = 37, Maximum = 185). Higher scores mean more positive outcomes.
Measured: Change in protective behavioral strategy use in comparison to control at 6-months.
Perceived peer drinking norms
Assessed via the drinking norms rating form (Minimum = 0, Maximum = unspecified). Higher scores mean worse outcomes.
Measured: Change in perceived peer norms relative to control at 6-months.
Perceived peer norms regarding sexual aggression: Perceived peer bystander intervention
Assessed via the sexual social norms inventory, perceived peer bystander intervention (Minimum = 8, Maximum = 40, higher scores better outcomes).
Measured: Change in perceived peer bystander intervention in comparison to control at 6-months.
Perceived peer norms regarding sexual aggression: Perceived peer engagement in sexual coercion
Assessed via the sexual social norms inventory, regarding perceived peer engagement in sexual coercion (Minimum = 7, Maximum = 35, lower are better outcomes).
Measured: Change in perceived peer engagement in comparison to control at 6-months.
Perceived peer norms regarding sexual aggression: Peer comfort with sexual aggression
Assessed via the sexual social norms inventory, perception of peer comfort with sexual aggression (Minimum = 7 , Maximum = 35, lower are better outcomes).
Measured: Change in peer comfort with sexual aggression relative to control at 6-months.
Attitudes relating to sexual aggression: Rape myth acceptance
Assessed via the rape myth acceptance scale (Minimum = 7, Maximum = 140, higher are worse outcomes).
Measured: Change in rape myth acceptance relative to control at 6-months.
Attitudes relating to sexual aggression: Hyper gender ideology
Assessed via the hyper gender ideology scale (Minimum = 19, Maximum = 114, higher scores are worse outcomes).
Measured: Change in hyper gender ideology and increases relative to control at 6-months.
Attitudes relating to sexual aggression: Labeling of consent
Assessed via the labeling of consent scenarios (Minimum = 1, Maximum= 10, higher scores are better outcomes).
Measured: Change in labeling of consent relative to control at 6-months.
Bystander intervention intention to help strangers
Assessed via the intentions to help strangers scale (Minimum = 0, Maximum = 800, higher scores are better outcomes).
Measured: Change in intention to help strangers relative to control at 6-months.
Bystander intervention intention to help friends
Assessed via the bystander intentions to help friends scale (Minimum = 0, Maximum = 1000, higher scores are better outcomes).
Measured: Change in intent to help friends relative to control at 6-months.
Bystander intervention attitudes
Assessed via the bystander attitudes scale (Minimum = 51, Maximum = 255, higher scores are better outcomes).
Measured: Change in bystander attitudes relative to control at 6-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start17 Oct 2013
- Primary completion13 Dec 2017
- Study completion13 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Orchowski Ph.D., Lifespan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773027
- Sponsor's protocol ID
- R34AA020852
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing requests can be made by contacting the study PI.
Publications
Orchowski LM, Merrill JE, Oesterle DW, Barnett NP, Borsari B, Zlotnick C, Haikalis MP, Bekowitz AD. Integrated Alcohol Use and Sexual Assault Prevention Program for College Men Who Engage in Heavy Drinking: Randomized Pilot Study. JMIR Form Res. 2023 Nov 23;7:e47354. doi: 10.2196/47354.
PubMed 37995129
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Alcohol and Sexual Assault Intervention for College Men
- ClinicalTrials.gov ID
- NCT05773027
- Acronym / sponsor ID
- R34AA020852
- Conditions
- Alcohol Drinking, Sexual Assault
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- LifespanUniversity, hospital or other
- Study start
- 17 Oct 2013 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 17 Mar 2023 (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 research will evaluate a new intervention that integrates evidence-based alcohol intervention strategies and promising sexual assault prevention strategies with the goal of decreasing sexual aggression among men who report heavy drinking; a particularly high risk group. Specifically, this study will conduct a randomized controlled pilot trial with college men who report heavy drinking to demonstrate the feasibility and acceptability of the proposed intervention. The main questions the study will answer are: 1) what is the feasibility of the recruitment plans, research design, intervention training methods, and delivery of the program?; and 2) does the intervention, relative to a mindfulness-based control condition, produce reductions in the quantity and frequency of alcohol use, perpetration of sexual aggression, and attitudes associated with sexual aggression over the 2- and 6-month follow-up. Follow-up assessments are completed at 2- and 6-months following the program. The intervention is compared to the mindfulness-based control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sexual Assault and Alcohol Feedback and Education (SAFE) | Experimental | Behavioral: SAFESAFE includes a motivational interviewing session addressing alcohol use and risk for sexual aggression, a workshop addressing alcohol use and sexual aggression, and a booster session review. |
| Mindfulness-Based Control Condition | Active comparator | Behavioral: Mindfulness-Based Control ConditionThe program includes the same amount of contacts as SAFE, including an individual session focused on mindfulness and stress, a group session, and a booster session review. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Engaging in binge drinking, defined as 5 or more drinks per day for men on the same occasion by the Substance Abuse and Mental Health Services Administration on two or more occasions in the past month.
- Engaging in oral, vaginal, or anal sexual intercourse with a female partner one or more times in the past four months
Key exclusion criteria (3 listed)
- Displaying symptoms consistent with alcohol use withdrawal
- Reporting current suicidal or homicidal ideation
- Meeting criteria consistent with a diagnosis of Antisocial Personality Disorder
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 |
|---|---|---|
| SAFESAFE includes a motivational interviewing session addressing alcohol use and risk for sexual aggression, a workshop addressing alcohol use and sexual aggression, and a booster session review. | Behavioural | Sexual Assault and Alcohol Feedback and Education (SAFE) |
| Mindfulness-Based Control ConditionThe program includes the same amount of contacts as SAFE, including an individual session focused on mindfulness and stress, a group session, and a booster session review. | Behavioural | Mindfulness-Based Control Condition |
Primary outcome
Alcohol use, heavy drinking quantity
Time frame: Change from baseline alcohol use at 6 months.
Number of heavy drinking days in the past month (Minimum = 0, Maximum = 31), assessed via the timeline follow-back. Greater scores mean worse outcomes.
Alcohol use, drinks per week
Time frame: Change from baseline alcohol use at 6 months.
The average number of drinks per week (Minimum = 0, Maximum = unspecified), assessed via the timeline follow-back. Greater scores mean worse outcomes.
Sexual aggression perpetration
Time frame: Change in severity and frequency in comparison to control at 6-months.
Assessed via the sexual experiences survey. Scored based on frequency and severity (Minimum = 0, Maximum = 63). Higher scores mean worse outcomes.
11 secondary outcomes
Protective behavioral strategies
Time frame: Change in protective behavioral strategy use in comparison to control at 6-months.
Perceived peer drinking norms
Time frame: Change in perceived peer norms relative to control at 6-months.
Perceived peer norms regarding sexual aggression: Perceived peer bystander intervention
Time frame: Change in perceived peer bystander intervention in comparison to control at 6-months.
Perceived peer norms regarding sexual aggression: Perceived peer engagement in sexual coercion
Time frame: Change in perceived peer engagement in comparison to control at 6-months.
Perceived peer norms regarding sexual aggression: Peer comfort with sexual aggression
Time frame: Change in peer comfort with sexual aggression relative to control at 6-months.
Attitudes relating to sexual aggression: Rape myth acceptance
Time frame: Change in rape myth acceptance relative to control at 6-months.
Attitudes relating to sexual aggression: Hyper gender ideology
Time frame: Change in hyper gender ideology and increases relative to control at 6-months.
Attitudes relating to sexual aggression: Labeling of consent
Time frame: Change in labeling of consent relative to control at 6-months.
Bystander intervention intention to help strangers
Time frame: Change in intention to help strangers relative to control at 6-months.
Bystander intervention intention to help friends
Time frame: Change in intent to help friends relative to control at 6-months.
Bystander intervention attitudes
Time frame: Change in bystander attitudes relative to control at 6-months.
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 17 Mar 2023.
- Derived from this study: PubMed 37995129Orchowski LM, Merrill JE, Oesterle DW, Barnett NP, Borsari B, Zlotnick C, Haikalis MP, Bekowitz AD. Integrated Alcohol Use and Sexual Assault Prevention Program for College Men Who Engage in Heavy Drinking: Randomized Pilot Study. JMIR Form Res. 2023 Nov 23;7:e47354. doi: 10.2196/47354.
- Individual participant dataSharing planned: Yes. Data sharing requests can be made by contacting the study PI.
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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 SAFE in people with Alcohol Drinking and Sexual Assault, run by Lifespan 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 2 inclusion and 3 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 17 Mar 2023. 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?
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?
Alcohol use, heavy drinking quantity (time frame: Change from baseline alcohol use at 6 months.). The study lists 3 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 NCT05773027, which also lists 1 linked publication.
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 Mar 2023.