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

Alcohol-related Disorders Clinical Trial

— AlcoholINET  

Official title:

Evaluation of an Intranet-Based Alcohol Prevention Program in Middle School

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847183
• Other study ID #: AA019671
• Secondary ID: R01AA019671
• Status: Completed
• Phase: Phase 2
• First received: April 25, 2013
• Last updated: October 5, 2016
• Start date: November 2012
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2300
• Est. completion date: June 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol-related Disorders
• Drinking and Driving
• Neurological Impairment

Intervention

Behavioral:
• Click City®: Alcohol
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.

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Research Institute	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?	one week following intervention; one year following intervention: two years following intervention	No
Secondary	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	one week following intervention; one year following intervention: two years following intervention	No

External Links

•   informational website for teachers and parents