- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02469779
Middle and High School Students' Reactions to a Health Interactive Website: ASPIRE Reactions
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.
Przegląd badań
Status
Szczegółowy opis
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).
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Texas
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Houston, Texas, Stany Zjednoczone, 77008
- Mt. Calvary Baptist Church
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Houston, Texas, Stany Zjednoczone, 77253
- Young Men's Christian Association (YMCA)
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Ages 11 through 18 (11 and 18 included)
- High school and Middle School students are both eligible
- All 150 are nonsmokers. Nonsmokers are defined as individuals who have not smoked, not even part of a cigarette in the past year.
- All will score above the median on smoking susceptibility
- 10 will be White/Caucasian participants, 5 will be African American participants, 10 will be Hispanic participants, and 5 will be Asian participants.
- English speaking
Exclusion Criteria:
1)None
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: 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.
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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.
Inne nazwy:
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.
Inne nazwy:
|
Aktywny 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.
Inne nazwy:
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.
Inne nazwy:
Participants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Intention to Smoke
Ramy czasowe: 1 day
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This outcome is measured using the validated susceptibility to smoke scale in a Likert scale format and baseline and immediate follow up.
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1 day
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Emotional Response
Ramy czasowe: 4 days
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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.
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4 days
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Participants' Reported Qualitatively Attributes in ASPIRE
Ramy czasowe: 1 day
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Participants' reported qualitatively attributes (i.e.
features) in ASPIRE that they recall to be emotionally involving.
This report conducted using open-ended questions.
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1 day
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Relationship Between Emotional Involvement During Use of ASPIRE Website and Change in Susceptibility to Smoking
Ramy czasowe: 1 day
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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.
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1 day
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Alex Prokhorov, MD, PhD, M.D. Anderson Cancer Center
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 2013-0296
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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