Alcohol DrinkingNCT04147520
Reducing Hazardous Alcohol Use in Social Networks Using Targeted Intervention: 21 Rising
A study testing Brief Motivational Interview in people with Alcohol Drinking and Alcohol; Harmful Use, run by Brown University at 1 site in United States.
Trial summary
The primary goal of this study is to determine whether change in alcohol use among college students can be transmitted through social network ties to other members in the network. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol; Harmful Use
- What is being tested?
- Brief Motivational Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,475 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2019to 31 Dec 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be a member of the class of 2021 or 2021.5 at the site university
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The primary goal of this study is to determine whether change in alcohol use among college students can be transmitted through social network ties to other members in the network. Members of one college class at a northeastern university will be enrolled in a longitudinal study in which they will provide self-reported behavioral information and information about their social ties to others in their college class. A subset of heavy drinking participants will be asked to meet in person to complete an interview about their alcohol use - called a Brief Motivational Interview. There is evidence that this sort of interview can reduce harmful alcohol use. The investigators expect that following the Brief Motivational Interview others in their friendship clusters will show reduced harm associated with alcohol use as well.
- Conditions
- Alcohol Drinking, Alcohol; Harmful Use
- Being tested
- Brief Motivational Interview
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational InterviewBehavioural
Single (60 min) session discussion of alcohol use and associated experiences.
| Study group | Role | What they receive |
|---|---|---|
| Brief Motivational Interview | Active comparator | Single-session in person conversation focusing on risks associated with alcohol use. Receives: Behavioral: Brief Motivational Interview |
| Natural History Control | No intervention | No contact. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol use
Average number of drinks per week in the past 30 days
Measured: At each follow up, measure average drinks per week in the past 30 days
Average number of alcohol consequences in the past 30 days
Count of alcohol consequences in the past 30 days
Measured: At each follow up, measure count of alcohol consequences in the past 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start7 Oct 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Nancy Barnett, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147520
- Sponsor's protocol ID
- 1810002247
- Other IDs
- 2R01AA023522
- Status last verified
- Jul 2021
- First submitted
- 23 Oct 2019
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is concern that with information in the dataset, including social ties, individuals could be re-identified.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Hazardous Alcohol Use in Social Networks Using Targeted Intervention: 21 Rising
- ClinicalTrials.gov ID
- NCT04147520
- Acronym / sponsor ID
- 1810002247
- Conditions
- Alcohol Drinking, Alcohol; Harmful Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,475 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Nov 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.
The primary goal of this study is to determine whether change in alcohol use among college students can be transmitted through social network ties to other members in the network. Members of one college class at a northeastern university will be enrolled in a longitudinal study in which they will provide self-reported behavioral information and information about their social ties to others in their college class. A subset of heavy drinking participants will be asked to meet in person to complete an interview about their alcohol use - called a Brief Motivational Interview. There is evidence that this sort of interview can reduce harmful alcohol use. The investigators expect that following the Brief Motivational Interview others in their friendship clusters will show reduced harm associated with alcohol use as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Motivational Interview | Active comparator | Behavioral: Brief Motivational InterviewSingle-session in person conversation focusing on risks associated with alcohol use. |
| Natural History Control | No intervention | –No contact. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be a member of the class of 2021 or 2021.5 at the site university
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Brief Motivational InterviewSingle (60 min) session discussion of alcohol use and associated experiences. | Behavioural | Brief Motivational Interview |
Primary outcome
Alcohol use
Time frame: At each follow up, measure average drinks per week in the past 30 days
Average number of drinks per week in the past 30 days
Average number of alcohol consequences in the past 30 days
Time frame: At each follow up, measure count of alcohol consequences in the past 30 days
Count of alcohol consequences in the past 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No. There is concern that with information in the dataset, including social ties, individuals could be re-identified.
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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.
Nancy Barnett, Ph.D. principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Interview in people with Alcohol Drinking and Alcohol; Harmful Use, run by Brown University 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 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 2 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?
Alcohol use (time frame: At each follow up, measure average drinks per week in the past 30 days). 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 2 Aug 2021.