NCT00680875

Brief Summary

The purpose of this research is to create an effective, disseminable, and exciting computer-based tobacco prevention program for 5th and 6th grade students. The goal of this school-based program is to decrease children's behavioral intentions and willingness to use tobacco, and to prevent or delay their initiation of tobacco use. We will augment the 5th grade program with a booster program in 6th grade, and evaluate the long-term efficacy of the entire tobacco prevention program by conducting a randomized controlled trial in elementary and middle schools.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

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

March 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

October 14, 2011

Status Verified

October 1, 2011

Enrollment Period

4.2 years

First QC Date

May 16, 2008

Last Update Submit

October 13, 2011

Conditions

Health PromotionTobacco Smoking

Keywords

School Based ServicesPreventionChildren

Outcome Measures

Primary Outcomes (1)

  • Self reported cigarette and smokeless tobacco use

    2 years

Secondary Outcomes (1)

  • Intention and willingness to smoke cigarettes or chew smokeless tobacco in the future.

    2 years

Study Arms (2)

Intervention

EXPERIMENTAL

5th and 6th grade students who attend schools randomly assigned to the intervention condition.

Behavioral: Click City

Usual Curriculum

NO INTERVENTION

5th and 6th grade students attending schools randomly assigned to the usual curriculum control condition.

Interventions

Click CityBEHAVIORAL

School-based intranet delivery of tobacco use prevention program for 5th and 6th graders using interactive and engaging game-like multi-media technology.

Also known as: Tobacco Free Town
Intervention

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • th and 6th grade students attending participating public schools in six counties within a one hour drive of Eugene

You may not qualify if:

  • Children must be able to read and understand English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco Use

Study Officials

  • Judy A Andrews, Ph.D.

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 20, 2008

Study Start

March 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

October 14, 2011

Record last verified: 2011-10

Locations

US(1)