Environmental Tobacco Smoke Exposure Reduction in High-Risk Preteens
Condition: Lung Diseases; Asthma
MeSH terms: Lung Diseases
Study type: Interventional

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).
    

Intervention name(s): Counseling; Urine Cotinine Feedback; Contingent Incentives; Usual education program
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): One-on-one behavioral counseling with pre-teen child; 8 to 10 weekly or bi-weekly sessions; focus on identifying sources of exposure to ETS and means to avoid exposure; goal-setting, role-playing, monitoring progress, feedback includes reported info and urine cotinine level.; Urine collected from child at each weekly/bi-weekly counseling session; cotinine level discussed at subsequent session.; Child earns small prizes for on-task behavior in sessions, plus earns tokens redeemable for other prizes based on reduction in ETS exposure (reported and cotinine level).; Participants will receive the usual education about ETS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention