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Evaluation of an School-based Alcohol Prevention Program for Middle School Students (AlcoholINET)

Primary Purpose

Alcohol-related Disorders, Drinking and Driving, Neurological Impairment

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Click City®: Alcohol
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol-related Disorders focused on measuring heavy drinking, prevention, high school, adolescence

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Click City®: Alcohol

Usual Curriculum

Arm Description

Receive the Click City®: Alcohol program as part of their school curriculum.

Students receive their usual alcohol curriculum

Outcomes

Primary Outcome Measures

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.
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?

Secondary Outcome Measures

Decrease willingness to get drink alcohol from baseline
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) Drink one drink Drink more than one drink Drink enough to get buzzed Drink enough to get drunk

Full Information

First Posted
April 25, 2013
Last Updated
October 5, 2016
Sponsor
Oregon Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01847183
Brief Title
Evaluation of an School-based Alcohol Prevention Program for Middle School Students
Acronym
AlcoholINET
Official Title
Evaluation of an Intranet-Based Alcohol Prevention Program in Middle School
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
The proposed program is unique both in its delivery system and the development process. The program will be delivered in a computer game like format over a school-based intranet system (i.e., networked computers linked to a school-based server), which enables users to interact individually with the program and to share their experiences by receiving immediate feedback on both their own responses and those of their classmates' collective responses. The delivery of this computer-based programs assures fidelity of implementation. Each activity (component) ultimately included in the program will be continually developed and tested to assure that it is effective at changing the targeted theoretically based etiological mechanism (risk factor). Development will include an experimental assessment to evaluate the effectiveness of each component and only effective components will be included in the program. The 7th grade version of Click City®: Alcohol program will consist of 12 effective components delivered in six sessions over a three-week period. This will be followed by two 8th grade booster sessions, consisting of a total of 5 components delivered over a one-week period. Educational newsletters to parents and teacher guides will be developed to accompany the program. The investigators will conduct a randomized efficacy trial with 26 middle schools. Half of the schools will use the newly developed program and the other half will use the programs that they usually do to teach about Alcohol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-related Disorders, Drinking and Driving, Neurological Impairment
Keywords
heavy drinking, prevention, high school, adolescence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Click City®: Alcohol
Arm Type
Experimental
Arm Description
Receive the Click City®: Alcohol program as part of their school curriculum.
Arm Title
Usual Curriculum
Arm Type
No Intervention
Arm Description
Students receive their usual alcohol curriculum
Intervention Type
Behavioral
Intervention Name(s)
Click City®: Alcohol
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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?
Time Frame
one week following intervention; one year following intervention: two years following intervention
Secondary Outcome Measure Information:
Title
Decrease willingness to get drink alcohol from baseline
Description
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) Drink one drink Drink more than one drink Drink enough to get buzzed Drink enough to get drunk
Time Frame
one week following intervention; one year following intervention: two years following intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Andrews, Ph.D.
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ori.org/clickcityalcohol
Description
informational website for teachers and parents

Learn more about this trial

Evaluation of an School-based Alcohol Prevention Program for Middle School Students

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