Smoking StatusNCT00398190
Media Literacy to Prevent Adolescent Smoking
A study testing Media Literacy in people with Smoking Status, run by University of Pittsburgh at 3 sites in United States.
Trial summary
The purpose of this project is to determine if a 3-session anti-smoking media literacy based intervention is more effective that a standard 3-session anti-smoking media literacy intervention at changing students' intention to smoke, actual smoking behavior, attitudes and norms regarding smoking, and level of media… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Status
- What is being tested?
- Media Literacy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,211 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2006to Jun 2009
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- High school student enrolled in health class at participating schools
- Must be able to use computer interface for submission of data
Who cannot join
- Child does not wish to participate
- Parent does not wish child to participate
- Less than 13 or more than 18 years old
Trial locations and contacts
3 sites in 1 country.
United States3 sites
McKeesport High School
McKeesport, Pennsylvania, 15132
Carrick High School
Pittsburgh, Pennsylvania, 15210
Schenley High School
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this project is to determine if a 3-session anti-smoking media literacy based intervention is more effective that a standard 3-session anti-smoking media literacy intervention at changing students' intention to smoke, actual smoking behavior, attitudes and norms regarding smoking, and level of media literacy.
Read the detailed description
Cigarette smoking is the top cause of preventable death and disease in the U.S., and about 90% of those who die from smoking begin as adolescents. Because smoking-related mass media messages (such as episodes of smoking in films and advertisements) significantly increase adolescent smoking, media literacy, defined as analysis and evaluation of mass media messages, presents a promising new framework for development of innovative school-based tobacco control programs. Media literacy may be more effective than standard tobacco education among the populations that are at greatest risk for smoking, such as African-Americans and the socio-economically disadvantaged, and national organizations have called for use of media literacy to reduce smoking. However, anti-smoking media literacy programs have been neither widely implemented nor well-evaluated.
The aims of this project are to determine if a theory-driven, school-based, 3-session anti-smoking media literacy curriculum delivered to 9th grade students can affect clinically relevant factors mediating adolescent smoking according to the widely accepted Theory of Reasoned Action: intention to smoke, smoking behavior, attitude toward smoking, and norms involving smoking. It is hypothesized that, compared with those exposed to a currently accepted school-based smoking prevention program, students exposed to the media literacy program will develop more negative attitudes toward smoking, a more negative sense of smoking norms, less intention to smoke, and less smoking. We also expect that the curriculum will improve smoking media literacy scores as measured by a reliable, valid scale.
Over two years, eight high schools will be recruited to randomize all 9th grade health classrooms to receive either the 3-session media literacy anti-smoking curriculum or a currently accepted anti-smoking program of equivalent length. This recruitment will occur via two prominent community organizations responsible for anti-tobacco programming in 50 local school districts. Experienced health educators will be trained in implementation of both experimental and control curricula. Outcome measures, demographic data, and other important covariates will be collected by a questionnaire given three times: at baseline, immediately post-intervention, and after one year. Questionnaire items are reliable, valid, and pilot-tested. Process evaluation will be conducted to assess implementation fidelity, to confirm or refute the findings of the quantitative assessment, to help explain outcome data, to refine the intervention, and to inform future replications of the curriculum.
Given the substantial nationwide morbidity and mortality due to tobacco use, the role of mass media messages in adolescent initiation of smoking, and the potential power of media literacy as an agent for health behavior change, it is essential to study the utility of media literacy in altering smoking behaviors and antecedents in this age group. If media literacy programs are successful in buffering the impact of mass media on adolescent smoking, similar interventions can be developed to prevent other harmful behaviors related to mass media messages.
- Conditions
- Smoking Status
- Being tested
- Control, Media Literacy
- Keywords
- Smoking, Tobacco use disorder
- Medical subject headings
- Smoking, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Standard anti-tobacco programming
Media LiteracyBehavioural
Anti-smoking media literacy curriculum intervention
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Students receive standard anti-tobacco education Receives: Behavioral: Control |
| Media Literacy | Experimental | Students receive media literacy based anti-smoking education Receives: Behavioral: Media Literacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Susceptibility to smoking (Pierce, 1996)
Measured: Immediate, Delayed
Current smoking (last 30 days)
Measured: Delayed (one year)
Smoking media literacy
Measured: Immediate, delayed (one year)
Secondary outcomes (4)
Attitudes toward smoking
Measured: Immediate, delayed (one year)
Subjective normative beliefs involving smoking
Measured: Immediate, delayed (one year)
Implementation fidelity
Measured: Immediate
Feasibility/acceptability of program
Measured: Immediate, delayed (one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Smoking StatusStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,211 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Brian Primack, University of Pittsburgh
- Investigators
- Brian A Primack, MD, EdM, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398190
- Sponsor's protocol ID
- 57407
- Status last verified
- Jul 2017
- First submitted
- 8 Nov 2006
- Last updated
- 26 Jul 2017
- Results posted
- No
Publications
Primack BA, Gold MA, Land SR, Fine MJ. Association of cigarette smoking and media literacy about smoking among adolescents. J Adolesc Health. 2006 Oct;39(4):465-72. doi: 10.1016/j.jadohealth.2006.05.011.
PubMed 16982379Primack BA, Gold MA, Switzer GE, Hobbs R, Land SR, Fine MJ. Development and validation of a smoking media literacy scale for adolescents. Arch Pediatr Adolesc Med. 2006 Apr;160(4):369-74. doi: 10.1001/archpedi.160.4.369.
PubMed 16585481Primack BA, Douglas EL, Land SR, Miller E, Fine MJ. Comparison of media literacy and usual education to prevent tobacco use: a cluster-randomized trial. J Sch Health. 2014 Feb;84(2):106-15. doi: 10.1111/josh.12130.
PubMed 25099425Primack BA, Fine D, Yang CK, Wickett D, Zickmund S. Adolescents' impressions of antismoking media literacy education: qualitative results from a randomized controlled trial. Health Educ Res. 2009 Aug;24(4):608-21. doi: 10.1093/her/cyn062. Epub 2008 Dec 3.
PubMed 19052155Primack BA, Hobbs R. Association of various components of media literacy and adolescent smoking. Am J Health Behav. 2009 Mar-Apr;33(2):192-201. doi: 10.5993/ajhb.33.2.8.
PubMed 18844513
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Media Literacy to Prevent Adolescent Smoking
- ClinicalTrials.gov ID
- NCT00398190
- Acronym / sponsor ID
- 57407
- Conditions
- Smoking Status
- Keywords
- Smoking, Tobacco use disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,211 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Oct 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 10 Nov 2006 (estimated)
- 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.
The purpose of this project is to determine if a 3-session anti-smoking media literacy based intervention is more effective that a standard 3-session anti-smoking media literacy intervention at changing students' intention to smoke, actual smoking behavior, attitudes and norms regarding smoking, and level of media literacy.
Detailed description
Cigarette smoking is the top cause of preventable death and disease in the U.S., and about 90% of those who die from smoking begin as adolescents. Because smoking-related mass media messages (such as episodes of smoking in films and advertisements) significantly increase adolescent smoking, media literacy, defined as analysis and evaluation of mass media messages, presents a promising new framework for development of innovative school-based tobacco control programs. Media literacy may be more effective than standard tobacco education among the populations that are at greatest risk for smoking, such as African-Americans and the socio-economically disadvantaged, and national organizations have called for use of media literacy to reduce smoking. However, anti-smoking media literacy programs have been neither widely implemented nor well-evaluated.
The aims of this project are to determine if a theory-driven, school-based, 3-session anti-smoking media literacy curriculum delivered to 9th grade students can affect clinically relevant factors mediating adolescent smoking according to the widely accepted Theory of Reasoned Action: intention to smoke, smoking behavior, attitude toward smoking, and norms involving smoking. It is hypothesized that, compared with those exposed to a currently accepted school-based smoking prevention program, students exposed to the media literacy program will develop more negative attitudes toward smoking, a more negative sense of smoking norms, less intention to smoke, and less smoking. We also expect that the curriculum will improve smoking media literacy scores as measured by a reliable, valid scale.
Over two years, eight high schools will be recruited to randomize all 9th grade health classrooms to receive either the 3-session media literacy anti-smoking curriculum or a currently accepted anti-smoking program of equivalent length. This recruitment will occur via two prominent community organizations responsible for anti-tobacco programming in 50 local school districts. Experienced health educators will be trained in implementation of both experimental and control curricula. Outcome measures, demographic data, and other important covariates will be collected by a questionnaire given three times: at baseline, immediately post-intervention, and after one year. Questionnaire items are reliable, valid, and pilot-tested. Process evaluation will be conducted to assess implementation fidelity, to confirm or refute the findings of the quantitative assessment, to help explain outcome data, to refine the intervention, and to inform future replications of the curriculum.
Given the substantial nationwide morbidity and mortality due to tobacco use, the role of mass media messages in adolescent initiation of smoking, and the potential power of media literacy as an agent for health behavior change, it is essential to study the utility of media literacy in altering smoking behaviors and antecedents in this age group. If media literacy programs are successful in buffering the impact of mass media on adolescent smoking, similar interventions can be developed to prevent other harmful behaviors related to mass media messages.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlStudents receive standard anti-tobacco education |
| Media Literacy | Experimental | Behavioral: Media LiteracyStudents receive media literacy based anti-smoking education |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- High school student enrolled in health class at participating schools
- Must be able to use computer interface for submission of data
Key exclusion criteria (3 listed)
- Child does not wish to participate
- Parent does not wish child to participate
- Less than 13 or more than 18 years old
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 |
|---|---|---|
| ControlStandard anti-tobacco programming | Behavioural | Control |
| Media LiteracyAnti-smoking media literacy curriculum intervention | Behavioural | Media Literacy |
Primary outcome
Susceptibility to smoking (Pierce, 1996)
Time frame: Immediate, Delayed
Current smoking (last 30 days)
Time frame: Delayed (one year)
Smoking media literacy
Time frame: Immediate, delayed (one year)
4 secondary outcomes
Attitudes toward smoking
Time frame: Immediate, delayed (one year)
Subjective normative beliefs involving smoking
Time frame: Immediate, delayed (one year)
Implementation fidelity
Time frame: Immediate
Feasibility/acceptability of program
Time frame: Immediate, delayed (one year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Background: PubMed 16982379Primack BA, Gold MA, Land SR, Fine MJ. Association of cigarette smoking and media literacy about smoking among adolescents. J Adolesc Health. 2006 Oct;39(4):465-72. doi: 10.1016/j.jadohealth.2006.05.011.
- Background: PubMed 16585481Primack BA, Gold MA, Switzer GE, Hobbs R, Land SR, Fine MJ. Development and validation of a smoking media literacy scale for adolescents. Arch Pediatr Adolesc Med. 2006 Apr;160(4):369-74. doi: 10.1001/archpedi.160.4.369.
- Background: PubMed 25099425Primack BA, Douglas EL, Land SR, Miller E, Fine MJ. Comparison of media literacy and usual education to prevent tobacco use: a cluster-randomized trial. J Sch Health. 2014 Feb;84(2):106-15. doi: 10.1111/josh.12130.
- Background: PubMed 19052155Primack BA, Fine D, Yang CK, Wickett D, Zickmund S. Adolescents' impressions of antismoking media literacy education: qualitative results from a randomized controlled trial. Health Educ Res. 2009 Aug;24(4):608-21. doi: 10.1093/her/cyn062. Epub 2008 Dec 3.
- Background: PubMed 18844513Primack BA, Hobbs R. Association of various components of media literacy and adolescent smoking. Am J Health Behav. 2009 Mar-Apr;33(2):192-201. doi: 10.5993/ajhb.33.2.8.
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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.
Brian A Primack, MD, EdM principal investigator
University of Pittsburgh
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Media Literacy in people with Smoking Status, run by University of Pittsburgh at 3 sites 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Susceptibility to smoking (Pierce, 1996) (time frame: Immediate, Delayed). The study lists 3 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 NCT00398190, which also lists 5 linked publications.
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 26 Jul 2017.