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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04083469
Other study ID # STUDY19040095
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 15, 2019
Est. completion date June 30, 2020

Study information

Verified date July 2020
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research will explore the feasibility of leveraging social network analysis to identify 6th grade opinion leaders to lead a school-based e-cigarette intervention. The project will be conducted for 6th graders in 8 schools in the Pittsburgh area.


Description:

Specific Aim 1: Participants will be recruited from 8 Pittsburgh-area schools. The investigators will conduct a social network survey for all 6th graders in each school. Students will be asked to identify their closest peers based on several relationship dynamics: friendship, opinion leadership, academic support, and personal support.

Specific Aim 2: The investigators will adapt modules from CATCH My Breath, an evidence-based, school-implemented e-cigarette intervention supported by University of Texas and MD Anderson Cancer Center. The 8 schools will be randomized to receive the intervention led by either (1) an adult content-expert or (2) a peer-nominated opinion leader to students who nominated them or (3) a peer-nominated opinion leader to students who did not nominate them. Surveys will be administered before and after the intervention. Primary outcomes will be acceptability and feasibility measures, including (1) recruitment and (2) retention rates. Secondary outcomes will include e-cigarette use, intention-to-use e-cigarettes, and knowledge about e-cigarettes.


Recruitment information / eligibility

Status Terminated
Enrollment 686
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 6th grade student at Linton, Founder's Hall, Woodland Hills, Steel Valley, Greensburgh Salem, Freedom, Marion, or Rostraver schools

Exclusion Criteria:

- Students who are unable to read the surveys will be excluded from data collection. However, all students will still participate in the e-cigarette program

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Peer-Led Peer-Elected Intervention
The intervention will be given to students by a peer opinion leader that the students in the audience elected. The intervention is a version of CATCH My Breath curriculum that has been modified to facilitate peer leadership.
Adult-Led Intervention
The intervention will be given to students by an adult. The intervention is a version of CATCH My Breath curriculum that has been modified to match the Peer-Led Intervention curriculum but is able to be administered by an adult.
Peer-Led Non-Elected Intervention
The intervention will be given to students by a peer opinion leader that was elected by other students. The intervention is a version of CATCH My Breath curriculum that has been modified to facilitate peer leadership.

Locations

Country Name City State
United States UPMC Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability: follow-up survey Acceptability of the intervention will be assessed via the follow-up survey administrated to students following the program.
Do you feel the lessons were appropriate for the subject?
Were you confident in the person conducting the lesson?
Questions will be measured in a 5 point Likert scale.
5 months
Primary Feasibility: recruitment and retention rates Feasibility of the intervention will be assessed via the recruitment and retention rates.
Recruitment = number of students who agree to participate / number of students in school
Retention = number of students who completed the program / number of students who began the program
5 months
Secondary Intention-to-use and knowledge about e-cigarettes (based on National Youth Tobacco Survey) Intention-to-use and knowledge about e-cigarettes will be assessed via the e-cigarette survey that will be administered after the program. Measures are adapted from the National Youth Tobacco Survey. 5 months
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