Asthma Clinical Trial
Official title:
ETS Reduction in High-Risk Preteens: A Controlled Trial
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.
BACKGROUND:
Parent counseling reduced children's 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 preteen's 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 racial/ethnic 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 ng/ml) and reliable procedures as
employed by CDC (ID-LC/MS/MS). 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
researcher's 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 alcohol/drugs 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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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