NCT00670995

Brief Summary

There have been a number of tobacco prevention programs developed and tested in the past few years, and some of the comprehensive programs have been promoted by the Office on Smoking and Health at the Centers for Disease Control (CDC). However, the use of these programs and integration into school-based curriculum has been lacking due to a number of factors. We are proposing to develop an interactive computer-based program for tobacco prevention aimed at middle school students. The CD-ROM is designed to be an adjunct to the existing health education curriculum provided for 6th through 8th grade students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,864

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 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

First Submitted

Initial submission to the registry

April 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2008

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

10 months

First QC Date

April 29, 2008

Last Update Submit

February 16, 2012

Conditions

Tobacco Use Disorder

Keywords

Tobacco use among middle and junior high school students remains a concern among health educators.The use of tobacco prevention programs and their integration into school-based curricula has been lacking due to a number of factors.

Outcome Measures

Primary Outcomes (1)

  • Increase perceived behavioral control (self-efficacy)

    pre and post

Secondary Outcomes (2)

  • Decrease willingness to use tobacco

    pre and post

  • Decrease intentions to use tobacco

    pre and post

Interventions

Interactive Tobacco EducationBEHAVIORAL

Increase perceived behavioral control (self-efficacy) Decrease willingness to use tobacco Decrease intentions to use tobacco

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Middle school students in 6th or 7th or 8th grade in Oregon and New York City whose parents have consented to have their child participate;
  • Middle school health education teachers in Oregon and New York City

You may not qualify if:

  • Students unable to understand English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deschutes Research Inc

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Herbert H Severson, PhD

    Deschutes Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2008

First Posted

May 2, 2008

Study Start

November 1, 2009

Primary Completion

September 1, 2010

Study Completion

November 1, 2010

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations

US(1)