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

5. februar 2021 opdateret af: M.D. Anderson Cancer Center

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.

Studieoversigt

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

700

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Texas
      • Houston, Texas, Forenede Stater, 77008
        • Mt. Calvary Baptist Church
      • Houston, Texas, Forenede Stater, 77253
        • Young Men's Christian Association (YMCA)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

11 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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.
Andre navne:
  • Spørgeskemaer
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
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.
Andre navne:
  • Spørgeskema
Aktiv komparator: 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.
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.
Andre navne:
  • Spørgeskemaer
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.
Andre navne:
  • Spørgeskema
Participants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intention to Smoke
Tidsramme: 1 day
This outcome is measured using the validated susceptibility to smoke scale in a Likert scale format and baseline and immediate follow up.
1 day

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Emotional Response
Tidsramme: 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.
4 days
Participants' Reported Qualitatively Attributes in ASPIRE
Tidsramme: 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.
1 day
Relationship Between Emotional Involvement During Use of ASPIRE Website and Change in Susceptibility to Smoking
Tidsramme: 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.
1 day

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Alex Prokhorov, MD, PhD, M.D. Anderson Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2013

Primær færdiggørelse (Faktiske)

1. februar 2021

Studieafslutning (Faktiske)

1. februar 2021

Datoer for studieregistrering

Først indsendt

9. juni 2015

Først indsendt, der opfyldte QC-kriterier

10. juni 2015

Først opslået (Skøn)

11. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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