NCT01847183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 6, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

April 25, 2013

Last Update Submit

October 5, 2016

Conditions

Keywords

heavy drinkingpreventionhigh schooladolescence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Decrease willingness to get drink alcohol from baseline

    one week following intervention; one year following intervention: two years following intervention

Study Arms (2)

Click City®: Alcohol

EXPERIMENTAL

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

Behavioral: Click City®: Alcohol

Usual Curriculum

NO INTERVENTION

Students receive their usual alcohol curriculum

Interventions

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.

Click City®: Alcohol

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • parents give passive consent for their students to participate. Students must attend a participating school.

You may not qualify if:

  • non-English speakers, some special Ed students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Alcohol-Related DisordersDriving Under the InfluenceNeurologic Manifestations

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersCriminal BehaviorBehaviorDangerous BehaviorNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Judy Andrews, Ph.D.

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2013

First Posted

May 6, 2013

Study Start

November 1, 2012

Primary Completion

November 1, 2015

Study Completion

June 1, 2016

Last Updated

October 6, 2016

Record last verified: 2016-10

Locations