Counseling to Reduce Children's SHS Exposure: A Trial With Maternal Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The goal of this study is to reduce infant and toddlers' secondhand smoke exposure (SHSe) in
      a high risk, medically underserved population of maternal smokers. The program is called
      "Philadelphia FRESH (Family Rules for Establishing Smokefree Homes)". Participants are
      recruited from low-income urban neighborhoods in Philadelphia, Pennsylvania. After
      determining study eligibility via telephone screen, all participants complete an in-home
      pre-intervention interview that includes self-reported smoking history, current smoking and
      exposure patterns, and factors that relate to maternal smoking (such as depressive symptoms,
      weight concerns, nicotine dependence,) as well as collection of child urine cotinine (a
      biomarker used to detect SHSe).

      Participants are randomized after baseline to receive either (a) a moderately intensive (up
      to 2 in-home sessions, 8 phone sessions) Behavioral Counseling intervention (BC) delivered
      over a 16-week period by counselors trained and supervised by investigators, or (b) an
      enhanced Self-Help Control (SHC) that uses brief advice and a detailed self-help manual for
      SHSe-reduction and smokingcessation. Post intervention assessments include self-reports of
      intervention process, factors associated with intervention effects, and intervention outcomes
      that include child urine cotinine (to measure level of SHSe) and participant saliva cotinine
      (to verify self-reported smoking quit status). Interviewers and data management staff remain
      blind to the treatment assignment. All procedures are implemented after signed informed
      consent and were approved by Temple University's Institutional Review Board.
    

Detailed description: 
      This study represents a community-based behavioral counseling trial designed to reduce infant
      and toddlers' secondhand smoke exposure (SHSe) in a high risk, medically underserved
      population of African American maternal smokers. The program is called "Philadelphia FRESH
      (Family Rules for Establishing Smokefree Homes)". Participants are recruited from low-income
      urban neighborhoods in Philadelphia, Pennsylvania via posters on mass transit, newspaper ads,
      and referral from pediatricians or community WIC clinics.

      Inclusion Criteria:

        -  mothers who smoke at least 5 cigarettes per day

        -  have a child under 4 years of age

        -  report exposing their youngest child to at least 2 of her cigarettes per day. (Child
           exposure to a cigarette is defined as a child being in the same room or car when adult
           is smoking. Room is defined as 4-walls and a door that closes.)

      Exclusion Criteria:

        -  Diagnosis of a Axis I psychiatric disorder

        -  pregnant

        -  not proficient in English.

      After determining study eligibility via telephone screen, all participants complete an
      in-home baseline interview that includes self-reported smoking history, current smoking and
      exposure patterns, and factors that relate to maternal smoking (such as depressive symptoms,
      weight concerns, nicotine dependence,) as well as collection of child urine cotinine (a
      biomarker used to detect SHSe).

      Participants are randomized to receive either a Behavioral Counseling intervention (BC)
      delivered over a 16-week period by master's level counselors trained and supervised by
      PhD-level investigators, or an enhanced Self-Help Control (SHC) that uses a detailed
      self-help manual for SHSe-reduction and smoking cessation. Post intervention assessments at
      16 weeks, 3- and 12-month follow-up include self-reports of factors associated with
      intervention effects and intervention outcomes that include child urine cotinine (to measure
      level of SHSe) and participant saliva cotinine (to verify self-reported smoking quit status).
      Interviewers and data management staff remain blind to the treatment assignment. All
      procedures are implemented after signed informed consent and were approved by Temple
      University's Institutional Review Board.

      Behavioral Counseling (BC): Mothers randomized to receive BC complete two in-home, and up to
      a 8 proactive telephone counseling sessions within a 16-week period. Mothers also receive
      four health education and self-help mailings sent in two week intervals during the first 8
      weeks of their participation to supplement the counseling content. (These four mailings are
      identical to the self-help materials received by the control group.) The overarching goal of
      child SHSe reduction is intended to be achieved through specific BC objectives. These
      objectives include facilitation of health education regarding the dangers of SHSe and
      smoking, plus the benefits of SHSe-reduction and smoking cessation to maternal and child
      health. Additional objectives include (a) building family-level social support to facilitate
      home-level smoking behavior change; (b) fostering coping and problem-solving skills to help
      participants manage smoking urges as well as general life stressors; (c) providing and
      modeling abundant positive reinforcement following SHSe reduction efforts to facilitate
      confidence and motivation for more challenging smoking behavior change goals.

      Self-Help Control (SHC) group: Participants in SHC group receive an intervention binder with
      brief advice by telephone on how to use the manual for SHSe reduction. The binder contains
      information identical to the BC group, however, all binder content is included in this single
      mailing.

      Primary study outcomes include change in (a) maternal-reported child SHSe (reported as
      cigarettes exposed per day) obtained via validated timeline follow-back methods; and (b) baby
      urine cotinine- a biomarker of SHSe standard in tobacco exposure studies. Secondary outcomes
      include (a) change in maternal cigarettes smoked per day and (b) maternal reported 7-day
      point prevalence abstinence, bioverified by saliva cotinine. Urine and saliva samples were
      assayed for cotinine using high performance liquid chromatography-tandem mass spectrometry as
      an indicator of exposure to tobacco smoke.
    

Intervention name(s): Behavioral Counseling; Self-help control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral counseling used components of evidence-based smoking intervention treatment to promote maternal smokers efforts in reducing their children's exposure to secondhand smoke.; This intervention group received a comprehensive self-help manual that included information and advice about how to protect children from secondhand smoke (e.g., adopting a smokefree home and car.)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: child secondhand smoke; maternal smoking; tobacco; nicotine; behavioral counseling; low-income; underserved