E-Cig UseNCT04083469
Identifying Student Opinion Leaders to Lead E-cigarette Interventions
A study testing Peer-Led Peer-Elected Intervention, Adult-Led Intervention and Peer-Led Non-Elected Intervention in people with E-Cig Use and Adolescent Behavior, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- E-Cig Use, Adolescent Behavior
- What is being tested?
- Peer-Led Peer-Elected Intervention, Adult-Led Intervention and Peer-Led Non-Elected Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 686 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 6th grade student at Linton, Founder's Hall, Woodland Hills, Steel Valley, Greensburgh Salem, Freedom, Marion, or Rostraver schools
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- E-Cig Use, Adolescent Behavior
- Being tested
- Peer-Led Peer-Elected Intervention, Adult-Led Intervention, Peer-Led Non-Elected Intervention
- Medical subject headings
- Vaping, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Led Peer-Elected InterventionBehavioural
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 InterventionBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer-Led Peer-Elected Intervention | Experimental | The e-cigarette intervention program will be administered to students by an elected peer leader. The audience will consist of students that nominated the peer-leader. Receives: Behavioral: Peer-Led Peer-Elected Intervention |
| Adult-Led Intervention | Other | The e-cigarette intervention program will be administered to students by an adult educator. Receives: Behavioral: Adult-Led Intervention |
| Peer-Led Non-Elected Intervention | Other | The e-cigarette intervention program will be administered to students by an elected peer leader. The audience will consist of students that nominated a different peer-leader. Receives: Behavioral: Peer-Led Non-Elected Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
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
Measured: 5 months
Secondary outcomes (1)
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start15 Oct 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Covid-19 resulted in school closures.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for E-Cig UseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigators will conduct a social network survey for 6th graders. Students will be asked to identify their close peers based on several dynamics: friendship, opinion leadership, academic support, and personal support. Social network analyses will identify opinion leaders based on network centrality measures. Surveys will be administered before and after the intervention. Investigators will adapt modules from CATCH My Breath, an evidence-based 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. Primary outcomes will be acceptability and feasibility measures, including (1)recruitment and (2)retention rates. Secondary outcomes will include intention-to-use e-cigarettes and knowledge about e-cigarettes.
- Masking
- None (open label)
- Enrolment
- 686 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Responsible party
- Principal investigator, Kar-Hai Chu, University of Pittsburgh
- Investigators
- Kar-Hai Chu, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083469
- Sponsor's protocol ID
- STUDY19040095
- Status last verified
- Jul 2020
- First submitted
- 19 Aug 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chu KH, Matheny S, Furek A, Sidani J, Radio S, Miller E, Valente T, Robertson L. Identifying student opinion leaders to lead e-cigarette interventions: protocol for a randomized controlled pragmatic trial. Trials. 2021 Jan 6;22(1):31. doi: 10.1186/s13063-020-04990-z.
PubMed 33407805
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Student Opinion Leaders to Lead E-cigarette Interventions
- ClinicalTrials.gov ID
- NCT04083469
- Acronym / sponsor ID
- STUDY19040095
- Conditions
- E-Cig Use, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19 resulted in school closures.
- Enrolment
- 686 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Investigators will conduct a social network survey for 6th graders. Students will be asked to identify their close peers based on several dynamics: friendship, opinion leadership, academic support, and personal support. Social network analyses will identify opinion leaders based on network centrality measures. Surveys will be administered before and after the intervention. Investigators will adapt modules from CATCH My Breath, an evidence-based 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. Primary outcomes will be acceptability and feasibility measures, including (1)recruitment and (2)retention rates. Secondary outcomes will include intention-to-use e-cigarettes and knowledge about e-cigarettes.
| Arm | Type | Receives |
|---|---|---|
| Peer-Led Peer-Elected Intervention | Experimental | Behavioral: Peer-Led Peer-Elected InterventionThe e-cigarette intervention program will be administered to students by an elected peer leader. The audience will consist of students that nominated the peer-leader. |
| Adult-Led Intervention | Other | Behavioral: Adult-Led InterventionThe e-cigarette intervention program will be administered to students by an adult educator. |
| Peer-Led Non-Elected Intervention | Other | Behavioral: Peer-Led Non-Elected InterventionThe e-cigarette intervention program will be administered to students by an elected peer leader. The audience will consist of students that nominated a different peer-leader. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 6th grade student at Linton, Founder's Hall, Woodland Hills, Steel Valley, Greensburgh Salem, Freedom, Marion, or Rostraver schools
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-Led Peer-Elected InterventionThe 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. | Behavioural | Peer-Led Peer-Elected Intervention |
| Adult-Led InterventionThe 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. | Behavioural | Adult-Led Intervention |
| Peer-Led Non-Elected InterventionThe 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. | Behavioural | Peer-Led Non-Elected Intervention |
Primary outcome
Acceptability: follow-up survey
Time frame: 5 months
Acceptability of the intervention will be assessed via the follow-up survey administrated to students following the program. 1. Do you feel the lessons were appropriate for the subject? 2. Were you confident in the person conducting the lesson? Questions will be measured in a 5 point Likert scale.
Feasibility: recruitment and retention rates
Time frame: 5 months
Feasibility of the intervention will be assessed via the recruitment and retention rates. 1. Recruitment = number of students who agree to participate / number of students in school 2. Retention = number of students who completed the program / number of students who began the program
1 secondary outcome
Intention-to-use and knowledge about e-cigarettes (based on National Youth Tobacco Survey)
Time frame: 5 months
Results and safety
The study was stopped early (reason given: Covid-19 resulted in school closures.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 33407805Chu KH, Matheny S, Furek A, Sidani J, Radio S, Miller E, Valente T, Robertson L. Identifying student opinion leaders to lead e-cigarette interventions: protocol for a randomized controlled pragmatic trial. Trials. 2021 Jan 6;22(1):31. doi: 10.1186/s13063-020-04990-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kar-Hai Chu, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-Led Peer-Elected Intervention, Adult-Led Intervention and Peer-Led Non-Elected Intervention in people with E-Cig Use and Adolescent Behavior, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid-19 resulted in school closures.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability: follow-up survey (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04083469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.