Counseling to Reduce Children's SHS Exposure: A Trial With Maternal Smokers

Not Applicable

Completed

• Conditions: Nicotine Dependence

• Registration Number: NCT02117947
• Lead Sponsor: Temple University

Brief 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.

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• 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.

Exclusion Criteria

• current diagnosis or treatment of a psychiatric disorder
• currently pregnant
• not proficient in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
child urine cotinine	baseline to 16 weeks	tobacco exposure biomarker measured in n/mL

Secondary Outcome Measures

Name	Time	Method
maternal reported child tobacco smoke exposure	baseline to 16 weeks	7-day point prevalence cigarettes per day exposed
maternal reported smoking	baseline - 16 weeks	7 day point prevalence cigarettes smoked per day
maternal smoking abstinence	baseline to 16 weeks	7-day cotinine-verified point prevalence abstinence

Trial Locations

Locations (1)

Temple University Health Behavior Research Clinic; 🇺🇸 Philadelphia, Pennsylvania, United States