Adolescent Behavior Clinical Trial
Official title:
Tobacco Initiation Prevention for Pittsburgh and Rural Area High School Students
Verified date | May 2024 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research project will explore the feasibility and acceptability of a web-based media literacy tobacco prevention program. The project will be conducted with 9th graders in two schools in the Pittsburgh area.
Status | Completed |
Enrollment | 339 |
Est. completion date | March 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility | Inclusion Criteria: - 9th grade student - enrolled at participating Pittsburgh-area school Exclusion Criteria: - Inability to read the surveys |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of eligible 9th grade students recruited to participate in the study | Parents will be asked to return an opt out form if they do not want their student to participate. Students will provide assent if they wish to participate. Recruitment will be determined by calculating the percentage of eligible 9th grade students not opted out by their parents that also provide assent. | 1 month | |
Primary | Percentage of participants retained through the final data collection | Retention will be calculated as the percentage of 9th grade students who completed the baseline survey and also completed the 12 month follow-up survey. | 12 months | |
Primary | Percentage of participants indicating moderate to high acceptability of the AD IT UP program | Acceptability of the intervention will be assessed with closed-ended and open-ended items on the post-test survey immediately following completion of the intervention.
Students will be asked on a 5-point Likert scale with responses ranging from Strongly Agree to Strongly Disagree (with a neutral middle) their agreement about the following: "I enjoyed AD IT UP," "I understood AD IT UP," "AD IT UP was easy to use," "I tried my hardest when I was doing AD IT UP," "I think AD IT UP would be helpful to other kids my age," "I would recommend AD IT UP to a friend," and "I agree with AD IT UP's message." An answer of "Strongly Agree" or "Agree" on these items indicates high and moderate acceptability, respectively. Each of these items will be assessed individually, not as an overall scale. Open-ended items will ask: what the student would change about AD IT UP, what the student liked about AD IT UP, what made AD IT UP fun, and what made AD IT UP not fun. |
post-test immediately following completion of the intervention | |
Secondary | Changes in intention to use tobacco products | Items adapted from the National Youth Tobacco Survey will be included in all 4 surveys. These items include the following with a 4-item response scale ranging from Definitely No to Definitely Yes:
Do you think you will smoke a cigarette in the next month? Do you think you will smoke a cigarette at any time during the next year? If one of your best friends offered you a cigarette, would you smoke it? These items will be repeated for hookah, e-cigarettes, and cigars and cigarillos. Answering anything other than "Definitely No" on any item is considered "positive intention to use tobacco products." For example, if a student answers "Definitely Yes" to one cigarette item but "Probably No" to the other items, that student has positive intention to use cigarettes. |
baseline vs. 12 months | |
Secondary | Changes in attitudes toward tobacco products | Items to measure attitudes toward tobacco products will be included in all 4 surveys. These items include the following with a 10-item response scale ranging from Strongly Disagree to Strongly Agree.
E-cigarettes are not as bad for your health as other products. Using tobacco products at parties is fun. Tobacco products help you deal with problems or stress. Smoking helps people stay thin. People who use e-cigarettes are more fun to be around than people who don't use e-cigarettes. If someone starts using tobacco products every day, it is very hard for them to stop (reverse coded). Smoking makes a person look more attractive. It would be very easy for me to get e-cigarettes if I wanted them. Change in attitudes will be determined by the average increase or decrease in agreement with these items. These items will be assessed individually and as an overall scale (range 0-80, with higher scores indicating a worse outcome). |
baseline vs. 12 months | |
Secondary | Changes in normative beliefs about tobacco products | Items to measure normative beliefs about tobacco products will be included in all 4 surveys. These items ask participants their rate how acceptable the following statements are among their friends using a 10-item response scale ranging from Very Acceptable to Very Unacceptable:
It is OK for people your age to smoke cigarettes. It is OK for people your age to use e-cigarettes. It is OK for people your age to use hookahs. It is OK for people your age to smoke cigars or cigarillos. A wealthy person is more likely to use tobacco products than a poor person. A successful person is more likely to use tobacco products than an unsuccessful person. Changes in normative beliefs will be determined by the average increase or decrease in perceived acceptability of these statements. These items will be assessed individually, as well as an overall scale (range 0-60 with higher scores indicating a worse outcome). |
baseline vs. 12 months | |
Secondary | Change in tobacco-related media literacy | Items to measure tobacco-related media literacy will be adapted from the Smoking Media Literacy Scale and included in all 4 surveys. The response scale for these 8 items is a 10-item scale from "Strongly Disagree" to "Strongly Agree."
Changes in media literacy will be determined by the average increase or decrease in agreement with these items. These items will be assessed individually, as well as an overall scale (range 0-80, with higher scores indicating a worse outcome). |
baseline vs. 12 months |
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