NCT05081843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 4, 2025

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

October 4, 2021

Results QC Date

April 29, 2025

Last Update Submit

June 3, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • Changes in Intention to Use Tobacco Products

    baseline vs. 12 month follow-up

  • Changes in Attitudes Toward Tobacco Products

    baseline vs. 12 month follow-up

  • Changes in Normative Beliefs About Tobacco Products

    baseline vs. 12 month follow-up

  • Change in Tobacco-related Media Literacy

    baseline vs. 12 month follow-up

Study Arms (2)

Usual Health Education Curriculum

ACTIVE COMPARATOR

Students will receive the school's usual health education curriculum.

Behavioral: Usual health education curriculum

Usual Health Education Curriculum plus Intervention

EXPERIMENTAL

Students will receive the school's usual health education curriculum. Students will also receive the intervention. Delivery of the intervention (i.e., timing, frequency) will be determined by discussing the results of the Aim 1 focus groups with teachers and administrators.

Behavioral: AD IT UP media literacy interventionBehavioral: Usual health education curriculum

Interventions

AD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media.

Usual Health Education Curriculum plus Intervention

The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.

Usual Health Education CurriculumUsual Health Education Curriculum plus Intervention

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • th grade student
  • enrolled at participating Pittsburgh-area school

You may not qualify if:

  • Inability to read the surveys

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Adolescent BehaviorTobacco UseVaping

Condition Hierarchy (Ancestors)

BehaviorSmoking

Results Point of Contact

Title
Dr. Jaime Sidani
Organization
University of Pittsburgh School of Public Health

Study Officials

  • Jaime Sidani, PhD MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 18, 2021

Study Start

March 1, 2022

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

June 4, 2025

Results First Posted

June 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Appropriate data from this project will be made available via the Open ScienceFramework, which is recommended by the University of Pittsburgh Library System. Shareable data generated during the project will include longitudinal survey results, which will contain both quantitative and qualitative information. Survey data will be sufficiently de-identified and formatted in a broadly accessible spreadsheet format. Generic participant ID numbers will be available to link data across survey timepoints. These data will be made available with accompanying metadata (i.e., file descriptors and codebook). For example, available codebooks will include labels and descriptors for each quantitative survey variable as well as definitions used for qualitative coding.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will become available approximately December 2023 and remain available for 3 years in accordance with the NIH Grants Policy Statement on Data Sharing.
Access Criteria
Interested researchers will contact the PI to request access.

Locations