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Alcohol AbusePhase 2NCT00183131

The iHealth Study in College Students

A Phase 2 study testing Brief Personalized Feedback in people with Alcohol Abuse and Alcohol Dependence, run by Boston Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this project was to test the feasibility of electronic mail recruitment and web screening for hazardous drinking, to compare different approaches to encouraging screening, and to estimate the effects of minimal and more extensive feedback in preparation for a future alcohol web-based brief… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Brief Personalized Feedback
How many people
4,300 participants
Where
1 siteUnited States
Study dates
Oct 2004to Nov 2004
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Full time student
  • College freshman

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston University

    Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Internet Screening and Brief Intervention for Hazardous Drinking in College Students: A Pilot Study

The objective of this project was to test the feasibility of electronic mail recruitment and web screening for hazardous drinking, to compare different approaches to encouraging screening, and to estimate the effects of minimal and more extensive feedback in preparation for a future alcohol web-based brief intervention study

Read the detailed description

This pilot study aims to test the feasibility of electronic mail recruitment and web screening for alcohol problems, to compare different approaches to encouraging screening, and to estimate the effects of minimal and more extensive feedback in preparation for a future alcohol web-based brief intervention study. To do so, 4300 freshman adult college students will be randomized to receive an electronic mail request to complete a web alcohol screening test using an alcohol-specific or a general wellness approach. The primary outcome is the proportion of respondents who complete alcohol screening. Additional outcomes include readiness to change drinking, help-seeking, alcohol consumption and consequences. The results of this pilot study will provide information useful to 1) colleges deciding how best to implement universal screening for hazardous alcohol use, and 2) in the preparation of a larger study of web-based screening and brief intervention for hazardous drinking in college students.

Being tested
Brief Personalized Feedback
Keywords
Alcohol, Alcohol abuse, Alcohol dependence, Alcohol consumption, Unhealthy alcohol use, Screening, Brief Intervention, Effectiveness, Electronic intervention, Web-based intervention, College students
Medical subject headings
Alcoholism, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief Personalized FeedbackBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the number of times a subject exceeded per occasion limits

  2. Drinking risky amounts

  3. Heavy episodic drinking

  4. Drinks per day

  5. Hazardous drinking

Secondary outcomes (4)

  1. Abstinence

  2. Readiness to change alcohol use

  3. Help-seeking

  4. Alcohol consequences

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startOct 2004
  3. Study completionNov 2004

Resources

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
Parallel groups
Masking
Single blind
Enrolment
4,300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00183131
Sponsor's protocol ID
NIAAASAI013759
Other IDs
P60AA013759, NIH P60 AA013759
Status last verified
Dec 2007
First submitted
9 Sep 2005
Last updated
6 May 2010
Results posted
No

Publications

  • Saitz R, Helmuth ED, Aromaa SE, Guard A, Belanger M, Rosenbloom DL. Web-based screening and brief intervention for the spectrum of alcohol problems. Prev Med. 2004 Nov;39(5):969-75. doi: 10.1016/j.ypmed.2004.04.011.

    PubMed 15475031

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brief Personalized Feedback in people with Alcohol Abuse and Alcohol Dependence, run by Boston Medical Center 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 3 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 6 May 2010. 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.

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?

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?

Change in the number of times a subject exceeded per occasion limits. The study lists 5 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 NCT00183131, 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 6 May 2010.

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