Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005331
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Providers for Smoking Prevention Programs
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
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 789 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 5000 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 12 and 4 12 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 organizationalcultural 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
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 789 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 5000 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 12 and 4 12 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 organizationalcultural 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL036171 | NIH | None | httpsreporternihgovquickSearchR01HL036171 |