Overview

This trial is active, not recruiting.

Conditions tobacco use cessation, tobacco prevention
Treatments surveys, aspire website, aspire text-based website, follow up survey
Sponsor M.D. Anderson Cancer Center
Collaborator National Institutes of Health (NIH)
Start date December 2013
End date December 2017
Trial size 700 participants
Trial identifier NCT02469779, 2013-0296, P30CA016672

Summary

The goal of this research study is to learn how middle and high school students react to an interactive website called ASPIRE ( A Smoking Prevention Interactive Experience) and health information online and what their preferences are when using ASPIRE.

Researchers hope to use the results of this study to design more effective online health programs to provide middle and high school students with up-to-date information about tobacco use, meditation, and general health and well-being.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Participants complete baseline survey. Participants view the ASPIRE website containing videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. This viewing will be videotaped and audio recorded. 3 to 4 sessions will be completed. After each website session, survey will be completed.
surveys Questionnaires
At baseline participants complete survey about their mental and physical health and their opinions concerning health information and the internet. The survey will take about 15-20 minutes to complete.
aspire website
Participants view the ASPIRE website containing videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. This viewing will be videotaped
follow up survey Questionnaire
Participants complete a follow-up survey about their opinions concerning health information and the internet immediately after they have completed their last session on the website.
(Active Comparator)
Participants complete baseline survey. Participants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living. This viewing will be videotaped and audio recorded. 3 to 4 sessions will be completed. After each website session, survey will be completed.
surveys Questionnaires
At baseline participants complete survey about their mental and physical health and their opinions concerning health information and the internet. The survey will take about 15-20 minutes to complete.
aspire text-based website
Participants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living.
follow up survey Questionnaire
Participants complete a follow-up survey about their opinions concerning health information and the internet immediately after they have completed their last session on the website.

Primary Outcomes

Measure
Intention to Smoke
time frame: 1 day

Secondary Outcomes

Measure
Emotional Response
time frame: 4 days
Participants' Reported Qualitatively Attributes in ASPIRE
time frame: 1 day
Relationship Between Emotional Involvement During Use of ASPIRE Website and Change in Susceptibility to Smoking
time frame: 1 day

Eligibility Criteria

Male or female participants from 11 years up to 18 years old.

Inclusion Criteria: 1. Ages 11 through 18 (11 and 18 included) 2. High school and Middle School students are both eligible 3. All 150 are nonsmokers. Nonsmokers are defined as individuals who have not smoked, not even part of a cigarette in the past year. 4. All will score above the median on smoking susceptibility 5. 10 will be White/Caucasian participants, 5 will be African American participants, 10 will be Hispanic participants, and 5 will be Asian participants. 6. English speaking Exclusion Criteria: 1)None

Additional Information

Official title Middle and High School Students' Reactions to a Health Interactive Website: ASPIRE Reactions
Principal investigator Alex Prokhorov, MD, PHD
Description Participants complete up to 2 separate parts. Part 1: For Part 1, participants complete a survey about their mental and physical health and their opinions concerning health information and the internet. The survey takes about 15-20 minutes to complete. Part 2: If the results of the survey show eligibility, participants complete Part 2 of the study. For Part 2 participants are randomly assigned (as in a roll of dice) to 1 of 2 study groups. Participants have a 1 in 3 chance of being assigned to receive standard care. Participants have a 2 in 3 chance of being assigned to use the ASPIRE website. This is done because no one knows if one study group is better, the same, or worse than the other group. If participant assigned to receive standard care, he or she is shown a website that has the same information presented in ASPIRE, but in text form. Participants in both groups sit in front of a computer and go onto a website. Both the ASPIRE website and the text-based website have been designed for middle and high school students. The ASPIRE website has videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. The text-based website only has health information facts about smoking, the benefits of meditation, and healthy living. Participants complete 3 to 4 sessions using either the ASPIRE website or the text-based website throughout their first semester. Each session lasts about 40 minutes. The use of the websites will be videotaped. Follow-Up Surveys: Participants complete a follow-up survey about their opinions concerning health information and the internet immediately after they complete their last session on the website. The follow-up surveys take about 15 minutes to complete. Length of Study: Active participation on this study is over after participants complete the follow-up survey. If participant does not continue onto Part 2 of the study, their active participation is over after they complete Part 1 of the study. Other Information: Participants take part in this study at their school during their after school program. During the use of the website, each study participant is individually videotaped and audio recorded. The videotapes and audio recordings are used to help the research staff analyze each participant's use of the websites. The video tapes and audio recordings are stored on a password-protected encrypted hard drive that is stored in a locked office at MD Anderson. Only the study researcher and authorized members of the research staff are allowed to use the videotapes and audio recordings (for research purposes).
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.