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

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Counseling
Self-help control
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring child secondhand smoke, maternal smoking, tobacco, nicotine, behavioral counseling, low-income, underserved

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Temple University Health Behavior Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral Counseling

Self-help control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

child urine cotinine
tobacco exposure biomarker measured in n/mL

Secondary Outcome Measures

maternal reported child tobacco smoke exposure
7-day point prevalence cigarettes per day exposed
maternal reported smoking
7 day point prevalence cigarettes smoked per day
maternal smoking abstinence
7-day cotinine-verified point prevalence abstinence

Full Information

First Posted
April 16, 2014
Last Updated
February 13, 2017
Sponsor
Temple University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02117947
Brief Title
Counseling to Reduce Children's SHS Exposure: A Trial With Maternal Smokers
Official Title
Behavioral Counseling to Reduce Children's Secondhand Smoke Exposure: A Trial With Maternal Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2004 (Actual)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
child secondhand smoke, maternal smoking, tobacco, nicotine, behavioral counseling, low-income, underserved

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-help control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Counseling
Intervention Description
Behavioral counseling used components of evidence-based smoking intervention treatment to promote maternal smokers efforts in reducing their children's exposure to secondhand smoke.
Intervention Type
Behavioral
Intervention Name(s)
Self-help control
Intervention Description
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.)
Primary Outcome Measure Information:
Title
child urine cotinine
Description
tobacco exposure biomarker measured in n/mL
Time Frame
baseline to 16 weeks
Secondary Outcome Measure Information:
Title
maternal reported child tobacco smoke exposure
Description
7-day point prevalence cigarettes per day exposed
Time Frame
baseline to 16 weeks
Title
maternal reported smoking
Description
7 day point prevalence cigarettes smoked per day
Time Frame
baseline - 16 weeks
Title
maternal smoking abstinence
Description
7-day cotinine-verified point prevalence abstinence
Time Frame
baseline to 16 weeks
Other Pre-specified Outcome Measures:
Title
post-treatment maternal reported child tobacco smoke exposure
Description
7-day point prevalence cigarettes per day exposed
Time Frame
3- and 12-month post treatment follow-up
Title
post-treatment child cotinine
Description
tobacco exposure biomarker measured in n/mL
Time Frame
3- and 12-month post treatment follow-up
Title
post-treatment maternal smoking abstinence
Description
7-day cotinine-verified point prevalence abstinence
Time Frame
3- and 12-month post treatment follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley N Collins, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Health Behavior Research Clinic
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24073063
Citation
Collins BN, Wileyto EP, Hovell MF, Nair US, Jaffe K, Tolley NM, Audrain-McGovern J. Proactive recruitment predicts participant retention to end of treatment in a secondhand smoke reduction trial with low-income maternal smokers. Transl Behav Med. 2011 Sep;1(3):394-9. doi: 10.1007/s13142-011-0059-6.
Results Reference
background
PubMed Identifier
19320618
Citation
Collins BN, Nair U, Hovell MF, Audrain-McGovern J. Smoking-related weight concerns among underserved, black maternal smokers. Am J Health Behav. 2009 Nov-Dec;33(6):699-709. doi: 10.5993/ajhb.33.6.7.
Results Reference
background
PubMed Identifier
23875066
Citation
Collins BN, Ibrahim JK, Hovell M, Tolley NM, Nair US, Jaffe K, Zanis D, Audrain-McGovern J. Residential smoking restrictions are not associated with reduced child SHS exposure in a baseline sample of low-income, urban African Americans. Health (Irvine Calif). 2010 Nov;2(11):1264-1271. doi: 10.4236/health.2010.211188.
Results Reference
background
PubMed Identifier
24040587
Citation
Collins BN, Ibrahim J. Pediatric Secondhand Smoke Exposure: Moving Toward Systematic Multi-Level Strategies to Improve Health. Glob Heart. 2012 Jul;7(2):161-165. doi: 10.1016/j.gheart.2012.05.001. No abstract available.
Results Reference
background
PubMed Identifier
24339721
Citation
Collins BN, Nair US, Shwarz M, Jaffe K, Winickoff J. SHS-Related Pediatric Sick Visits are Linked to Maternal Depressive Symptoms among Low-Income African American Smokers: An Opportunity for Intervention in Pediatrics. J Child Fam Stud. 2013 Oct;22(7):1013-21. doi: 10.1007/s10826-012-9663-4.
Results Reference
background
PubMed Identifier
24294302
Citation
Shwarz M, Collins BN, Nair US. Factors associated with maternal depressive symptoms among low-income, African American smokers enrolled in a secondhand smoke reduction programme. Ment Health Fam Med. 2012 Dec;9(4):275-87.
Results Reference
background
PubMed Identifier
21254795
Citation
Collins BN, DiSantis KI, Nair US. Longer previous smoking abstinence relates to successful breastfeeding initiation among underserved smokers. Breastfeed Med. 2011 Dec;6(6):385-91. doi: 10.1089/bfm.2010.0076. Epub 2011 Jan 21.
Results Reference
background
PubMed Identifier
17452234
Citation
Collins BN, Levin KP, Bryant-Stephens T. Pediatricians' practices and attitudes about environmental tobacco smoke and parental smoking. J Pediatr. 2007 May;150(5):547-52. doi: 10.1016/j.jpeds.2007.01.006.
Results Reference
background
PubMed Identifier
31759804
Citation
Collins BN, Nair US, DiSantis KI, Hovell MF, Davis SM, Rodriguez D, Audrain-McGovern J. Long-term Results From the FRESH RCT: Sustained Reduction of Children's Tobacco Smoke Exposure. Am J Prev Med. 2020 Jan;58(1):21-30. doi: 10.1016/j.amepre.2019.08.021. Epub 2019 Nov 21.
Results Reference
derived
PubMed Identifier
30522566
Citation
Collins BN, Nair US, Davis SM, Rodriguez D. Increasing Home Smoking Restrictions Boosts Underserved Moms' Bioverified Quit Success. Am J Health Behav. 2019 Jan 1;43(1):50-56. doi: 10.5993/AJHB.43.1.5.
Results Reference
derived
PubMed Identifier
26028355
Citation
Collins BN, Nair US, Hovell MF, DiSantis KI, Jaffe K, Tolley NM, Wileyto EP, Audrain-McGovern J. Reducing Underserved Children's Exposure to Tobacco Smoke: A Randomized Counseling Trial With Maternal Smokers. Am J Prev Med. 2015 Oct;49(4):534-44. doi: 10.1016/j.amepre.2015.03.008. Epub 2015 May 28.
Results Reference
derived

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

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