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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

Tracking Information
First Submitted Date  ICMJE June 9, 2015
First Posted Date  ICMJE June 11, 2015
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE December 2013
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
Comparison of Emotional Responses of High Susceptibility to Smoking Group to Low Susceptibility [ Time Frame: 1 day ]
Observed responses in both groups measured using the Likert scale. One-way ANOVA conducted to compare high smoking-susceptibility participants to low smoking-susceptibility participants with respect to their survey reported emotional involvement.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2015)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2015)
Participant Reported Emotionally Involving Features of ASPIRE Website [ Time Frame: 1 day ]
Qualitative identification of attributes (i.e., features) in ASPIRE that participants report to be emotionally involving ascertained by focus group discussions, during which participants interact as they answer questions.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: June 10, 2015)
  • Comparison of changes in Smoking-Related Outcomes from ASPIRE Group and Control Group [ Time Frame: 1 day ]
    Susceptibility to smoking measured on the basis of 2 Likert-Scale measures. Scores ordered according to increasing susceptibility scores. Change in each smoking-related outcome conducted by subtracting the smoking-related outcome at baseline from the smoking-related outcome at each follow up (i.e., at 1, 2, 4-week follow up). Smoking-related outcomes are smoking susceptibility, decisional balance, temptation to try smoking, and self-efficacy to resisting smoking and interpersonal discussion against smoking.
  • 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 the use of ASPIRE features, and data for emotional expression. Recorded videos of participants' 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.
 
Descriptive Information
Brief Title  ICMJE Middle and High School Students' Reactions to a Health Interactive Website: ASPIRE Reactions
Official Title  ICMJE Middle and High School Students' Reactions to a Health Interactive Website: ASPIRE Reactions
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.

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Tobacco Use Cessation
  • Tobacco Prevention
Intervention  ICMJE
  • 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: 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Surveys
    • Behavioral: ASPIRE Website
    • Behavioral: Follow Up Survey
  • 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.
    Interventions:
    • Behavioral: Surveys
    • Behavioral: ASPIRE Text-Based Website
    • Behavioral: Follow Up Survey
Publications * Khalil GE, Wang H, Calabro KS, Mitra N, Shegog R, Prokhorov AV. From the Experience of Interactivity and Entertainment to Lower Intention to Smoke: A Randomized Controlled Trial and Path Analysis of a Web-Based Smoking Prevention Program for Adolescents. J Med Internet Res. 2017 Feb 16;19(2):e44. doi: 10.2196/jmir.7174.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2015)
700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02469779
Other Study ID Numbers  ICMJE 2013-0296
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Alex Prokhorov, MD, PHD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP