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

NCT02117947 | Completed

• 1 other identifier: R01CA105183
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Keywords

child secondhand smoke; maternal smoking; tobacco; nicotine; behavioral counseling; low-income; underserved

Outcome Measures

Primary Outcomes (1)

• child urine cotinine

  tobacco exposure biomarker measured in n/mL

  baseline to 16 weeks

Secondary Outcomes (3)

• maternal reported child tobacco smoke exposure

  baseline to 16 weeks

• maternal reported smoking

  baseline - 16 weeks

• maternal smoking abstinence

  baseline to 16 weeks

Other Outcomes (3)

• post-treatment maternal reported child tobacco smoke exposure

  3- and 12-month post treatment follow-up

• post-treatment child cotinine

  3- and 12-month post treatment follow-up

• post-treatment maternal smoking abstinence

  3- and 12-month post treatment follow-up

Study Arms (2)

Behavioral Counseling

EXPERIMENTAL

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

Self-help control

ACTIVE COMPARATOR

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

Interventions

Behavioral Counseling BEHAVIORAL

Behavioral counseling used components of evidence-based smoking intervention treatment to promote maternal smokers efforts in reducing their children's exposure to secondhand smoke.

Behavioral Counseling

Self-help control BEHAVIORAL

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.)

Self-help control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Temple University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Temple University Health Behavior Research Clinic

Philadelphia, Pennsylvania, 19122, United States

Location

Related Publications (11)

• 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.

  PMID: 24073063 BACKGROUND

• 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.

  PMID: 19320618 BACKGROUND

• 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.

  PMID: 23875066 BACKGROUND

• 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.

  PMID: 24040587 BACKGROUND

• 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.

  PMID: 24339721 BACKGROUND

• 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.

  PMID: 24294302 BACKGROUND

• 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.

  PMID: 21254795 BACKGROUND

• 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.

  PMID: 17452234 BACKGROUND

• 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.

  PMID: 31759804 DERIVED

• 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.

  PMID: 30522566 DERIVED

• 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.

  PMID: 26028355 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Bradley N Collins, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: July 1, 2004
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)