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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469779
Recruitment Status : Active, not recruiting
First Posted : June 11, 2015
Last Update Posted : September 10, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.


Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Tobacco Prevention Behavioral: Surveys Behavioral: ASPIRE Website Behavioral: ASPIRE Text-Based Website Behavioral: Follow Up Survey Not Applicable

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Middle and High School Students' Reactions to a Health Interactive Website: ASPIRE Reactions
Actual Study Start Date : December 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: ASPIRE Group
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.
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.
Other Name: Questionnaires

Behavioral: 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

Behavioral: 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.
Other Name: Questionnaire

Active Comparator: Control Group
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.
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.
Other Name: Questionnaires

Behavioral: ASPIRE Text-Based Website
Participants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living.

Behavioral: 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.
Other Name: Questionnaire




Primary Outcome Measures :
  1. Intention to Smoke [ Time Frame: 1 day ]
    This outcome is measured using the validated susceptibility to smoke scale in a Likert scale format and baseline and immediate follow up.


Secondary Outcome Measures :
  1. Emotional Response [ Time Frame: 4 days ]
    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.

  2. Participants' Reported Qualitatively Attributes in ASPIRE [ Time Frame: 1 day ]
    Participants' reported qualitatively attributes (i.e. features) in ASPIRE that they recall to be emotionally involving. This report conducted using open-ended questions.

  3. Relationship Between Emotional Involvement During Use of ASPIRE Website and Change in Susceptibility to Smoking [ Time Frame: 1 day ]
    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.



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.


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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


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): NCT02469779


Locations
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United States, Texas
Mt. Calvary Baptist Church
Houston, Texas, United States, 77008
Young Men's Christian Association (YMCA)
Houston, Texas, United States, 77253
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Alex Prokhorov, MD, PHD M.D. Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02469779    
Other Study ID Numbers: 2013-0296
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Tobacco Prevention
ASPIRE Website
Surveys
Questionnaires
Focus Groups
Health Interactive Website