Providers for Smoking Prevention Programs

NCT ID: NCT00005331

Last Updated: 2016-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

1988-09-30

Study Completion Date

1995-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To conduct a randomized controlled smoking prevention trial to evaluate quality of implementation and effectiveness, as a function of provider type (school teacher vs. nurse) and training (mediated vs. interactive).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

DESIGN NARRATIVE:

The study compared smoking prevention in junior high schools and in high schools either receiving or not receiving a school-wide community intervention. The junior high school curriculum was delivered to all volunteers in grades 6, 7, and 8 in each intervention school. All participants were tested five times: midway through grade 6 before the intervention began, and at the end of grades 7,8,9, and 10. The primary endpoint was self-reported smoking status at the ends of grades 8 and 10. The validity of smoking reports was enhanced with collection of breath carbon monoxide samples for all subjects at all test points.

The study was extended for an additional three years to add to the three year, junior high, design a two arm comparison between high schools either receiving or not receiving a school-wide, community, intervention. The new high school intervention responded to both recent evidence of long term decay in junior high program effectiveness, and a trend toward greater high school smoking onset most notably among females. Secondary objectives for this Demonstration and Education research included (a) a test of the hypothesis that higher levels of implementation were associated with better outcomes; (b) preparation for diffusion of a complete set of curriculum, provider training, program implementation, and evaluation methods and materials; and (c) study of the effects of school environment on program effectiveness.

One hundred junior high schools were randomly selected and assigned, 20 per condition, and some 5,000 Grade 6 youth with approximately the same number of females and males, recruited to cohort which participated in intervention and evaluation through the end of Grade 10. The junior high curriculum was delivered to all volunteers in each intervention school in Grades 6, 7, and 8. All participants were tested five times: midway through Grade 6 before the intervention began, and at the end of Grades 7, 8, 9 and 10. The primary endpoint was self-reported smoking status at the ends of Grades 8 and 10, 2 1/2 and 4 1/2 years after the intervention began. The validity of smoking reports were enhanced with collection of breath carbon monoxide samples from all subjects at all test points.

The new high school intervention integrated three approaches: attitude-behavior change strategies derived from social psychological research on dissonance, self-perception, values, social norms, and commitment; organizational/cultural change strategies using student- driven participatory planning and multilevel change methods; and mobilization strategies adapted from the National Cancer Institute-funded Community Intervention Trial for Smoking Cessation (COMMIT). A comprehensive implementation evaluation used direct observation, multiple sources of self-report, program records, and cost data to assess the relationships between implementation, outcome, and cost- effectiveness; to provide direct measures of training and mobilization effects; and to develop feasible implementation evaluation methodology for future diffusion studies.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases Coronary Heart Disease Risk Reduction Heart Diseases Lung Diseases

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

No eligibility criteria
Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

References

Explore related publications, articles, or registry entries linked to this study.

Santi SM, Best JA, Payne ME, Brown KS, Cameron R. A comparison between instructional experience and performance of teachers and nurses delivering a smoking prevention program. Can J Public Health. 1992 Nov-Dec;83(6):433-6.

Reference Type BACKGROUND
PMID: 1286445 (View on PubMed)

Santi SM, Cargo M, Brown KS, Best JA, Cameron R. Dispositional risk factors for smoking-stage transitions: a social influences program as an effect modifier. Addict Behav. 1994 May-Jun;19(3):269-85. doi: 10.1016/0306-4603(94)90029-9.

Reference Type BACKGROUND
PMID: 7942245 (View on PubMed)

Cameron R, Brown KS, Best JA, Pelkman CL, Madill CL, Manske SR, Payne ME. Effectiveness of a social influences smoking prevention program as a function of provider type, training method, and school risk. Am J Public Health. 1999 Dec;89(12):1827-31. doi: 10.2105/ajph.89.12.1827.

Reference Type BACKGROUND
PMID: 10589310 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HL036171

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4152

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Helping Poor Smokers Quit
NCT03194958 COMPLETED NA