An interventional study of Behavioral Counseling and Self-help control in Nicotine Dependence, sponsored by Temple University. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-02-15.
Sponsored by Temple University · Not applicable, Interventional, and Treatment
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.
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:
Exclusion Criteria:
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 300 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Temple University is the lead sponsor of 219 studies on the registry; 30 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral counseling used evidence-based smoking cessation intervention components as well as a theoretically-framed focus on behavioral shaping to promote the adoption of smoke-free homes and cars. Sessions included two, 1-hour in-home counseling and seven, 5-15 minute telephone follow-up sessions over 16 weeks. Content included health ed around the benefits of eliminating children's exposure to secondhand smoke; skills training around adoption and maintenance of smoke-free environments; goal setting, problem solving, and positive reinforcement for progress toward goals; coping skills training for smoking urge and mood management; and home support for maternal smoking behavior change achieve through family contracts and home detailing promoting pro-smoke-free home norms.
Behavioral: Behavioral Counseling
The self-help control group received a comprehensive self-help manual that outlined all of the goals and strategies covered in counseling, however, counseling was not provided to this group.
Behavioral: Self-help control
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.)
child urine cotinine
tobacco exposure biomarker measured in n/mL
Time frame: baseline to 16 weeks
maternal reported child tobacco smoke exposure
7-day point prevalence cigarettes per day exposed
Time frame: baseline to 16 weeks
maternal reported smoking
7 day point prevalence cigarettes smoked per day
Time frame: baseline - 16 weeks
maternal smoking abstinence
7-day cotinine-verified point prevalence abstinence
Time frame: baseline to 16 weeks
post-treatment maternal reported child tobacco smoke exposure
7-day point prevalence cigarettes per day exposed
Time frame: 3- and 12-month post treatment follow-up
post-treatment child cotinine
tobacco exposure biomarker measured in n/mL
Time frame: 3- and 12-month post treatment follow-up
post-treatment maternal smoking abstinence
7-day cotinine-verified point prevalence abstinence
Time frame: 3- and 12-month post treatment follow-up
Plan to share: No
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