Clinical trial NCT00217893: Environmental Tobacco Smoke Exposure Reduction in High-Risk Preteens
Official title: ETS Reduction in High-Risk Preteens: A Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Asthma
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-09-22
Enrollment: 203
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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).

Eligibility criteria: Inclusion Criteria:

* Non-smoking preteen
* Resides in San Diego county
* Smoker lives in the household
* Exposed to an average of 2 cigarettes per day over the week prior to study entry OR urine cotinine greater than or equal to 2.0 ng/mL

Exclusion Criteria:

* Preteen who has smoked in the 30 days prior to study entry or who has smoked more than 10 cigarettes within lifetime

Primary outcomes:
measure: ETS exposure
timeFrame: Measured from baseline to 5 months
measure: Maintenance in ETS exposure-reduction
timeFrame: Measured 5, 9, and 12 months post-baseline
Secondary outcomes:
measure: Tobacco use experimentation
timeFrame: Measured from baseline through 5, 9, and 12 months
measure: Experimentation with alcohol/drugs
timeFrame: Measured from baseline through 5, 9, and 12 months
measure: Avoidance of ETS exposure from family members and friends
timeFrame: Measured from baseline through 5, 9, and 12 months
measure: Multiple social and possible genetic factors that are independent and in combined association with ETS exposure and change in exposure
timeFrame: Measured from baseline through 5, 9, and 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Melbourne F. Hovell
role: STUDY_CHAIR
References: