Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 9 of 21 for:    E-cigarettes youth

Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03682900
Recruitment Status : Not yet recruiting
First Posted : September 25, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Oregon Research Behavioral Intervention Strategies, Inc.

Brief Summary:

The overarching goal of the proposed Phase II research is to demonstrate the short-term effectiveness of the modification of an existing, effective, computer-based, tobacco prevention program, Click City®: Tobacco, to prevent the initiation of e-cig use among youth.

A secondary goal is to modify the program to increase marketability by expanding the range of devices on which the program can be delivered (e.g., tablets to desktops), simplifying the student user interface, and providing more robust teacher/administrator functionality.


Condition or disease Intervention/treatment Phase
Tobacco Use Other: Click City Tobacco Prevention Program Not Applicable

Detailed Description:

In a previous research study the investigators developed and tested an effective tobacco prevention program to be used in 5th and 6th grade classrooms as tobacco prevention curriculum. The prevalence of e-cigarette (e-cig) use has recently increased dramatically, greatly exceeding that of cigarette use. Considering the health effects of e-cigs, and the increased probability that adolescents will become addicted to nicotine through the use of e-cigs a crucial need was recognized for the incorporation of e-cigs into the original tobacco prevention program. In Phase I the investigators were able to create two new activities that changed specific risk factors predictive of e-cig use. Two existing activities were modified to target not only risk factors related to smoking but also to e-cigarette use. Phase II will develop additional content targeting e-cigs and modify graphics and language throughout the program to include e-cigs. The finished program will contain 10 lessons to be used in fifth grade classrooms and a booster containing 6 activities to be used in sixth grade classrooms.

This project, which targets 5th graders with a booster in 6th grade, aims to prevent the initiation of the use of tobacco products including e-cigs, later in adolescence. This school-based, internet delivered program targets established risk factors predictive of youth's behavioral intentions and willingness to use tobacco products, both predictors of subsequent use.

This Phase II project proposes to complete development of the product by creating and integrating content that specifically targets risk factors/mechanisms predictive of e-cig use into all existing activities that previously targeted only conventional tobacco use. These modified activities will be integrated into a 10-lesson program and will be based on insights gathering during Phase I. The student user interface and teacher and administrative portals will be modified to increase ease of use. The entire program will be updated to contemporary web standards (e.g. HTML5/CSS/JavaScript) to allow for better integration into a broad range of school environments representing diverse hardware and software platforms. The resulting program will be assessed on both the effectiveness of decreasing youth's intentions and willingness to use both e-cigs and conventional cigarettes

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3636 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: Click City Tobacco Prevention Program
Click City program used as part of school curriculum
Other: Click City Tobacco Prevention Program
Fifth and sixth grade classroom tobacco prevention computer activities designed to postpone or prevent youth smoking, through changing theoretically-based risk factors predictive of subsequent use.

No Intervention: Usual Tobacco Prevention Curriculum
Will vary by school district.



Primary Outcome Measures :
  1. Change intentions to smoke [ Time Frame: Baseline, up to week 10 ]
    Intentions to smoke in the next year and in the future will be assessed on a 1-5 scale (from "definitely not" to "definitely will").

  2. Change intentions to use e-cigarettes [ Time Frame: Baseline, up to week 10 ]
    Intentions to use e-cigarettes in the next year and in the future will be assessed on a 1-5 scale (from "definitely not" to "definitely will").


Secondary Outcome Measures :
  1. Change willingness to smoke [ Time Frame: Baseline, up to week 10 ]
    6 scales to measure willingness to smoke if the opportunity arose, including if offered and if available with response items ranging from 'not at all willing' (=1) to 'very willing' (=5).

  2. Change willingness to use e-cigarettes [ Time Frame: Baseline, up to week 10 ]
    6 scales to measure willingness to use e-cigarettes if the opportunity arose, including if offered and if available with response items ranging from 'not at all willing' (=1) to 'very willing' (=5).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English speaking and reading, sighted, hearing 5th grade students in participating schools
  • passive parental consent to participate

Exclusion Criteria:

  • non-English speakers
  • students who are unable to read at 5th grade level

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682900


Contacts
Layout table for location contacts
Contact: David R Smith 541-484-2123 david.smith@influentsin.com

Sponsors and Collaborators
Oregon Research Behavioral Intervention Strategies, Inc.
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Judy Andrews Oregon Research Behavioral Intervention Strategies, Inc.

Layout table for additonal information
Responsible Party: Oregon Research Behavioral Intervention Strategies, Inc.
ClinicalTrials.gov Identifier: NCT03682900    
Other Study ID Numbers: DA044025
2R44DA044025 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oregon Research Behavioral Intervention Strategies, Inc.:
e-cigarettes
prevention
middle school
smoking