Middle and High School Students' Reactions to a Health Interactive Website: ASPIRE Reactions

Tobacco Use Cessation Clinical Trial

Official title:

Middle and High School Students' Reactions to a Health Interactive Website: ASPIRE Reactions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469779
• Other study ID #: 2013-0296
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2021
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Prevention
• Tobacco Use Cessation

Intervention

Behavioral:
• Surveys
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
• 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
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.

Locations

Country	Name	City	State
United States	Mt. Calvary Baptist Church	Houston	Texas
United States	Young Men's Christian Association (YMCA)	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intention to Smoke	This outcome is measured using the validated susceptibility to smoke scale in a Likert scale format and baseline and immediate follow up.	1 day
Secondary	Emotional Response	Outcome measured using validated Likert scales. In addition, facial expressions of happiness, sadness, disgust, fear, anger, and surprise are measured using a software program of emotion recognition for facial movement. The software captures the extent of expression of each of the emotions on a scale from 0 to 1.	4 days
Secondary	Participants' Reported Qualitatively Attributes in ASPIRE	Participants' reported qualitatively attributes (i.e. features) in ASPIRE that they recall to be emotionally involving. This report conducted using open-ended questions.	1 day
Secondary	Relationship Between Emotional Involvement During Use of ASPIRE Website and Change in Susceptibility to Smoking	Generation of emotional expression during use of ASPIRE is dependent on data for use of ASPIRE features, and data for emotional expression. Recorded videos of participant's online behavior analyzed via manual content analysis. Recorded videos of online behavior (i.e. mouse movement on the screen, clicking, dragging behaviors, and what the webpage presents) also analyzed using N-vivo.	1 day

External Links

•   University of Texas MD Anderson Cancer Center Website