- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01847183
Evaluation of an School-based Alcohol Prevention Program for Middle School Students (AlcoholINET)
Evaluation of an Intranet-Based Alcohol Prevention Program in Middle School
The purpose of this research is to create and evaluate the efficacy of an exciting (fun to use), and potentially disseminable computer-based prevention program, Click City®: Alcohol, for use by 7th graders with a booster in 8th grade students. The ultimate goal of Click City®: Alcohol is to prevent the onset of heavy drinking during high school and post-high school. Secondary goals of the program include decreasing students' intentions and willingness to engage in heavy drinking in high school. The proposed program is unique both in its delivery system and the development process.
Aim 1: The investigators plan to develop and test approximately 24 components over the first two years of the study.
Aim 2: The final Click City®: Alcohol program will consist of 12 effective components delivered in six sessions over a three-week period in 7th grade. This is followed by two booster sessions, consisting of a total of 5 components delivered over a one-week period in 8th grade. Educational newsletters to parents and teacher guides will accompany the program.
Aim 3: Following development, the investigators will conduct a group randomized trial to evaluate the efficacy of this program as compared to schools' usual alcohol prevention curriculum. The investigators plan to recruit, stratify and randomly assign 26 middle schools to one of the two conditions, Click City®: Alcohol and Usual Curriculum (UC). Students in the Click City®: Alcohol and yoked UC schools will be assessed prior to the beginning of the 7th grade program, following the 7th grade program, following the 8th grade booster, which would occur approximately one year after the 7th grade program, and a follow-up assessment in the 9th grade to assess long-term outcomes, one year after the 8th grade assessment.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Oregon
-
Eugene, Oregon, United States, 97403
- Oregon Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- parents give passive consent for their students to participate. Students must attend a participating school.
Exclusion Criteria:
- non-English speakers, some special Ed students
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Click City®: Alcohol
Receive the Click City®: Alcohol program as part of their school curriculum.
|
A school based program, Click City®: Alcohol consists of 12 effective components delivered in 7th grade and a booster of 5 effective components delivered in 8th grade.
|
NO_INTERVENTION: Usual Curriculum
Students receive their usual alcohol curriculum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease intentions to get drunk from baseline to one week follow-up; from baseline to one-year follow-up and from baseline to two-year followup.
Time Frame: one week following intervention; one year following intervention: two years following intervention
|
Intention is measured by two items: Do you think you will get drunk (from drinking too much alcohol) when you are in high school? Do you think you will get drunk (from drinking too much alcohol) when you are older? |
one week following intervention; one year following intervention: two years following intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease willingness to get drink alcohol from baseline
Time Frame: one week following intervention; one year following intervention: two years following intervention
|
Willingness is measured by: This is a "suppose" question. Think about yourself in this situation. We are not saying that you would be in this situation. We just want you to think about it, then tell us how you would act. Suppose you were with a group of friends and there was some alcohol there and you could have it if you wanted. How willing would you be to do each of the following: (check on Not at all willing, a little willing, kind of willing, pretty willing, very willing)
|
one week following intervention; one year following intervention: two years following intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Judy Andrews, Ph.D., Oregon Research Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA019671
- R01AA019671 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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