Providers for Smoking Prevention Programs

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).

Study Overview

Detailed Description

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1988

Study Completion (Actual)

February 1, 1995

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

July 1, 2000

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Diseases

Subscribe