Counseling to Reduce Children's SHS Exposure: A Trial With Maternal Smokers
Completed · Not applicable
Conditions studied: Nicotine Dependence
In brief
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.
Key facts
- Study ID
- NCT02117947
- Run by
- Temple University
- People needed
- 300
- Starts
- 2004-07-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2017-02-15
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Mothers who smoke at least 5 cigarettes per day
- have at least one child under 4 years of old (youngest child is target child for data collection (urine cotinine)
- report exposing youngest (target) child to at least 2 of her cigarettes/day (defined as child in the same room [4-walls and a door that closes] or car when someone is actively smoking a cigarette.
You may not qualify if…
- current diagnosis or treatment of a psychiatric disorder
- currently pregnant
- not proficient in English
Where it is running
- Temple University Health Behavior Research Clinic — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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