Intranet-based Tobacco Prevention Program for Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT00680875
First received: May 16, 2008
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Health Promotion
Tobacco Smoking
Behavioral: Click City

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

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Self reported cigarette and smokeless tobacco use [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intention and willingness to smoke cigarettes or chew smokeless tobacco in the future. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 3225
Study Start Date: March 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
5th and 6th grade students who attend schools randomly assigned to the intervention condition.
Behavioral: Click City
School-based intranet delivery of tobacco use prevention program for 5th and 6th graders using interactive and engaging game-like multi-media technology.
Other Name: Tobacco Free Town
No Intervention: Usual Curriculum
5th and 6th grade students attending schools randomly assigned to the usual curriculum control condition.

Detailed Description:

The aims of this randomized trail are as follows:

  • Conduct a randomized trial to assess the effectiveness of the Tobacco Free Town (TFT) program at preventing or delaying initiation of tobacco by 7th grade, and decreasing behavioral intentions and willingness to use tobacco, as compared to the usual tobacco-prevention curriculum implemented in schools. The TFT program consists of 17 effective components delivered in eight sessions over a four-week period in 5th grade with two booster sessions delivered within a one-week period in 6th grade.
  • Develop and test the effectiveness of 7 components to include in the booster sessions in 6th grade using an iterative development process including qualitative evaluation using focus and user groups, and culminating in a quantitative evaluation assessing the effectiveness of individual program components.
  • Develop a program guide for teachers to accompany the program and develop parent newsletters for teachers to send home with students after each session.
  • Examine change from 5th to 7th grade in the mechanisms that the TFT program is designed to target, and assess if these cognitive mechanisms serve to mediate the effects of the program on smoking outcomes.
  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 5th and 6th grade students attending participating public schools in six counties within a one hour drive of Eugene

Exclusion Criteria:

  • Children must be able to read and understand English.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680875

Locations
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Judy A Andrews, Ph.D. Oregon Research Institute
  More Information

No publications provided

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00680875     History of Changes
Other Study ID Numbers: CA98555
Study First Received: May 16, 2008
Last Updated: October 13, 2011
Health Authority: United States: Federal Government

Keywords provided by Oregon Research Institute:
School Based Services
Prevention
Children

ClinicalTrials.gov processed this record on September 22, 2014