Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217893
Status:
COMPLETED
Last Update Posted:
2013-10-24
First Post:
2005-09-19
Brief Title:
Environmental Tobacco Smoke Exposure Reduction in High-Risk Preteens
Sponsor:
San Diego State University
Organization:
San Diego State University
Study Overview
Official Title:
ETS Reduction in High-Risk Preteens A Controlled Trial
Status:
COMPLETED
Status Verified Date:
2013-10
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:
This study will determine the effect of combining counseling urine cotinine feedback and incentives in reducing environmental tobacco smoke ETS exposure and susceptibility to smoking among high-risk preteens
Detailed Description:
BACKGROUND
Parent counseling reduced childrens ETS exposure in previous studies This study will determine if interventions directed to preteens alone can reduce ETS exposure The original pilot study showed that counseling reduced preteens ETS exposure New analyses showed that counseling reduced exposure to preteens in the NIH asthma study A third pilot study showed that counseling plus feedback and incentives reduced preteens ETS exposure Based on these results the number of counseling sessions were decreased to 10 inclusion criteria were liberalized and recruitment sources were added to assure feasibility
DESIGN NARRATIVE
This study will determine the effect of combining counseling feedback and incentives on reducing second hand smoke SHS exposure and susceptibility to smoking among high-risk preteens Two hundred youth aged 8 to 13 years old including African American Latino Anglo and other racialethnic groups will be recruited Preteens must be nonsmokers who are exposed to ETS in their home Youth will be recruited sequentially and assigned to usual education or a combination of counseling cotinine feedback and contingent incentives Outcome measures will be obtained prior to intervention and at Months 5 9 and 12 Preteens in the intervention condition will receive eight in-home counseling sessions and seven phone counseling sessions over a 5-month period Urine samples will be analyzed for cotinine using highly sensitive detection limit 05 ngml and reliable procedures as employed by CDC ID-LCMSMS The same measures will be used for cotinine feedback for preteens in the intervention condition Repeated measures analyses of differential exposure to ETS will be employed Mixed effect regression REML and generalized estimating equations GEE models will be used for outcome analyses Exploratory analyses will address questions about the environmental and social determinants of tobacco use and ETS exposure based on the researchers Behavioral Ecological Model
Primary objectives include the following 1 to determine whether counseling plus cotinine feedback and incentives reduces ETS exposure more than does usual tobacco control education measured by self-report ETS exposure by preteen and parent and preteen urine cotinine at Month 5 and 2 to determine whether the experimental condition results in differential maintenance in ETS exposure-reduction compared to usual tobacco control education during follow-up measured by self-report ETS exposure by preteen and parent and preteen urine cotinine at Months 9 and 12
Secondary objectives include the following 1 to explore whether there is a differential rate of cigarette experimentation between groups to explore whether there is a differential rate of experimentation with alcoholdrugs among groups 2 to explore the differential level of tobacco use susceptibility among experimental groups 3 to explore the degree to which youth avoid ETS exposure from family members and friends and 4 to explore the multiple social and possible genetic factors that are independent and in combined association with ETS exposure and change in exposure measured by preteen and parent self-report at Months 5 9 and 12
Parent counseling reduced childrens ETS exposure in previous studies This study will determine if interventions directed to preteens alone can reduce ETS exposure The original pilot study showed that counseling reduced preteens ETS exposure New analyses showed that counseling reduced exposure to preteens in the NIH asthma study A third pilot study showed that counseling plus feedback and incentives reduced preteens ETS exposure Based on these results the number of counseling sessions were decreased to 10 inclusion criteria were liberalized and recruitment sources were added to assure feasibility
DESIGN NARRATIVE
This study will determine the effect of combining counseling feedback and incentives on reducing second hand smoke SHS exposure and susceptibility to smoking among high-risk preteens Two hundred youth aged 8 to 13 years old including African American Latino Anglo and other racialethnic groups will be recruited Preteens must be nonsmokers who are exposed to ETS in their home Youth will be recruited sequentially and assigned to usual education or a combination of counseling cotinine feedback and contingent incentives Outcome measures will be obtained prior to intervention and at Months 5 9 and 12 Preteens in the intervention condition will receive eight in-home counseling sessions and seven phone counseling sessions over a 5-month period Urine samples will be analyzed for cotinine using highly sensitive detection limit 05 ngml and reliable procedures as employed by CDC ID-LCMSMS The same measures will be used for cotinine feedback for preteens in the intervention condition Repeated measures analyses of differential exposure to ETS will be employed Mixed effect regression REML and generalized estimating equations GEE models will be used for outcome analyses Exploratory analyses will address questions about the environmental and social determinants of tobacco use and ETS exposure based on the researchers Behavioral Ecological Model
Primary objectives include the following 1 to determine whether counseling plus cotinine feedback and incentives reduces ETS exposure more than does usual tobacco control education measured by self-report ETS exposure by preteen and parent and preteen urine cotinine at Month 5 and 2 to determine whether the experimental condition results in differential maintenance in ETS exposure-reduction compared to usual tobacco control education during follow-up measured by self-report ETS exposure by preteen and parent and preteen urine cotinine at Months 9 and 12
Secondary objectives include the following 1 to explore whether there is a differential rate of cigarette experimentation between groups to explore whether there is a differential rate of experimentation with alcoholdrugs among groups 2 to explore the differential level of tobacco use susceptibility among experimental groups 3 to explore the degree to which youth avoid ETS exposure from family members and friends and 4 to explore the multiple social and possible genetic factors that are independent and in combined association with ETS exposure and change in exposure measured by preteen and parent self-report at Months 5 9 and 12
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL066307 | NIH | None | httpsreporternihgovquickSearchR01HL066307 |