Alcohol UseNCT01694082
Brief Web-Based Alcohol Reduction Intervention for Undergraduates
A study testing THRIVE in people with Alcohol Use and Heavy Drinking, run by Yale University at 1 site in United States.
Trial summary
Tertiary Health Research Intervention Via Email (THRIVE; Kypri et al., 2009), originally utilized with Australian students, is unique in that it contains efficacious components derived from motivational interviewing (e.g., personalized feedback) and cognitive behavioral therapy (protective behavioral strategies), yet… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Heavy Drinking, Negative Consequences of Alcohol Use
- What is being tested?
- THRIVE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jun 2014
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be a current student at Albertus Magnus College in New Haven, CT
Who cannot join
- Under 18 years of age
- 25 years of age or older
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06519
About this study
Official title: Randomized, Controlled Trial of a Brief, Web-Based Alcohol Reduction Intervention for Undergraduates
Tertiary Health Research Intervention Via Email (THRIVE; Kypri et al., 2009), originally utilized with Australian students, is unique in that it contains efficacious components derived from motivational interviewing (e.g., personalized feedback) and cognitive behavioral therapy (protective behavioral strategies), yet is very brief and has established efficacy. This study aims to test versions of THRIVE tailored to American college students. In addition to replicating original results with THRIVE, we will also test versions containing unique subsets of protective behavioral strategies to reduce alcohol consumption. The primary hypothesis is that versions of THRIVE will be associated with lower overall alcohol consumption than an assessment and brief brochure control condition.
- Being tested
- THRIVE, Brief brochure and assessment control
- Keywords
- brief intervention, web-based interventions, computer-based interventions, harm reduction, young adult, college student
- Medical subject headings
- Alcohol Drinking, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVEBehavioural
Also called Tertiary Health Research Intervention Via Email
THRIVE stands for (Tertiary Health Research Intervention Via Email). Participants complete questions related to demographics and their alcohol use and receive brief personalized feedback based on this information, in addition to protective behavioral strategies, facts about alcohol and information about available resources to reduce their alcohol use.
Brief brochure and assessment controlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| THRIVE replication | Experimental | Participants in this condition receive THRIVE with a full list of direct and indirect protective behavioral strategies to reduce alcohol consumption. Receives: Behavioral: THRIVE |
| THRIVE direct strategies | Experimental | Participants in this condition receive THRIVE including a subset of protective behavioral strategies that are directly related to alcohol drinking. Receives: Behavioral: THRIVE |
| THRIVE indirect strategies | Experimental | Participants in this condition receive THRIVE including a subset of protective behavioral strategies that are indirectly related to alcohol drinking. Receives: Behavioral: THRIVE |
| Brief brochure and assessment control | Sham comparator | Participants will answer the same survey questions as participants in the THRIVE conditions, but will receive a brief alcohol-related brochure with only didactic content rather than the intervention components received by participants randomized to THRIVE conditions. Receives: Behavioral: Brief brochure and assessment control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of alcohol use
Measured: 1-month post-intervention
Protective behavioral strategy use
Measured: 1-month post-intervention
Overall Weekly Alcohol Consumption
Measured: 1-month post-intervention
Secondary outcomes (3)
Frequency of heavy drinking days
Measured: 1-month post-intervention
Frequency of alcohol use
Measured: 6-months post-intervention
Overall weekly alcohol consumption
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 posted26 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionJun 2014
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 UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Alcoholic Beverage Medical Research Foundation, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Robert Leeman, Yale University
- Investigators
- Robert F Leeman, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694082
- Sponsor's protocol ID
- 1207010596
- Other IDs
- K01AA019694
- Status last verified
- Jun 2014
- First submitted
- 20 Sep 2012
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Frohe T, Gebru NM, Wilson B, Leeman RF. Is a very brief web-based intervention with focus on protective behavioral strategies efficacious in reducing impaired control over alcohol in undergraduates? Exp Clin Psychopharmacol. 2025 Feb;33(1):1-7. doi: 10.1037/pha0000737. Epub 2024 Aug 15.
PubMed 39146062
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial of a Brief, Web-Based Alcohol Reduction Intervention for Undergraduates
- ClinicalTrials.gov ID
- NCT01694082
- Acronym / sponsor ID
- 1207010596
- Keywords
- brief intervention, web-based interventions, computer-based interventions, harm reduction, young adult, college student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Alcoholic Beverage Medical Research Foundation, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Sep 2012 (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.
Tertiary Health Research Intervention Via Email (THRIVE; Kypri et al., 2009), originally utilized with Australian students, is unique in that it contains efficacious components derived from motivational interviewing (e.g., personalized feedback) and cognitive behavioral therapy (protective behavioral strategies), yet is very brief and has established efficacy. This study aims to test versions of THRIVE tailored to American college students. In addition to replicating original results with THRIVE, we will also test versions containing unique subsets of protective behavioral strategies to reduce alcohol consumption. The primary hypothesis is that versions of THRIVE will be associated with lower overall alcohol consumption than an assessment and brief brochure control condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| THRIVE replication | Experimental | Behavioral: THRIVEParticipants in this condition receive THRIVE with a full list of direct and indirect protective behavioral strategies to reduce alcohol consumption. |
| THRIVE direct strategies | Experimental | Behavioral: THRIVEParticipants in this condition receive THRIVE including a subset of protective behavioral strategies that are directly related to alcohol drinking. |
| THRIVE indirect strategies | Experimental | Behavioral: THRIVEParticipants in this condition receive THRIVE including a subset of protective behavioral strategies that are indirectly related to alcohol drinking. |
| Brief brochure and assessment control | Sham comparator | Behavioral: Brief brochure and assessment controlParticipants will answer the same survey questions as participants in the THRIVE conditions, but will receive a brief alcohol-related brochure with only didactic content rather than the intervention components received by participants randomized to THRIVE conditions. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Must be a current student at Albertus Magnus College in New Haven, CT
Key exclusion criteria (2 listed)
- Under 18 years of age
- 25 years of age or older
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 |
|---|---|---|
| THRIVEAlso: Tertiary Health Research Intervention Via EmailTHRIVE stands for (Tertiary Health Research Intervention Via Email). Participants complete questions related to demographics and their alcohol use and receive brief personalized feedback based on this information, in addition to protective behavioral strategies, facts about alcohol and information about available resources to reduce their alcohol use. | Behavioural | THRIVE direct strategies, THRIVE indirect strategies, THRIVE replication |
| Brief brochure and assessment control | Behavioural | Brief brochure and assessment control |
Primary outcome
Frequency of alcohol use
Time frame: 1-month post-intervention
Protective behavioral strategy use
Time frame: 1-month post-intervention
Overall Weekly Alcohol Consumption
Time frame: 1-month post-intervention
3 secondary outcomes
Frequency of heavy drinking days
Time frame: 1-month post-intervention
Frequency of alcohol use
Time frame: 6-months post-intervention
Overall weekly alcohol consumption
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 16 Jun 2014.
- Derived from this study: PubMed 39146062Frohe T, Gebru NM, Wilson B, Leeman RF. Is a very brief web-based intervention with focus on protective behavioral strategies efficacious in reducing impaired control over alcohol in undergraduates? Exp Clin Psychopharmacol. 2025 Feb;33(1):1-7. doi: 10.1037/pha0000737. Epub 2024 Aug 15.
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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.
Robert F Leeman, Ph.D. principal investigator
Yale 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 THRIVE in people with Alcohol Use and Heavy Drinking, run by Yale 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 2 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 16 Jun 2014. 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. Some participants in this study may receive a placebo. 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?
Frequency of alcohol use (time frame: 1-month post-intervention). 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 NCT01694082, 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 16 Jun 2014.