Clinical trial NCT05081843: Pittsburgh and Rural Area High School Tobacco Prevention
Official title: Tobacco Initiation Prevention for Pittsburgh and Rural Area High School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Tobacco Use
E-Cig Use
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-10-18
Enrollment: 318
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Specific Aim 1: To assess 9th grade students' preferences for delivery of the web-based media literacy tobacco prevention program. Investigators will conduct focus groups with 9th grade students in each high school. Students will be shown clips from the program and asked to provide feedback about the preferred frequency and setting for the program.

Specific Aim 2: Investigators will conduct a pilot trial of the intervention via a cluster randomized controlled trial. The control group will receive their usual health education curriculum. The intervention group will receive their usual health education curriculum with the addition of the intervention. All students will be asked to complete a pre-test, a post-test, and two follow-up surveys (approximately 4 and 12 months post-intervention). Feasibility endpoints will include overall program completion, recruitment/attendance rates, and retention rates. Acceptability outcomes will assess student perceptions toward the intervention. A sub-aim will be to conduct focus groups and interviews with students, teachers, and administrators to assess implementation barriers and facilitators.

Eligibility criteria: Inclusion Criteria:

* 9th grade student
* enrolled at participating Pittsburgh-area school

Exclusion Criteria:

* Inability to read the surveys

Primary outcomes:
measure: Percentage of Eligible 9th Grade Students Recruited to Participate in the Study
timeFrame: 1 month
measure: Percentage of Participants Retained Through the Final Data Collection
timeFrame: 12 months
measure: Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program
timeFrame: post-test immediately following completion of the intervention
Secondary outcomes:
measure: Changes in Intention to Use Tobacco Products
timeFrame: baseline vs. 12 month follow-up
measure: Changes in Attitudes Toward Tobacco Products
timeFrame: baseline vs. 12 month follow-up
measure: Changes in Normative Beliefs About Tobacco Products
timeFrame: baseline vs. 12 month follow-up
measure: Change in Tobacco-related Media Literacy
timeFrame: baseline vs. 12 month follow-up
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jaime Sidani, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: