Clinical trial NCT01745393: Kids Safe and Smokefree (KiSS)
Official title: Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Second Hand Tobacco Smoke
Nicotine Dependence
Keywords: Smoking Cessation
Secondhand Smoke
Passive Smoking
Cotinine
Nicotine Replacement Products
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: St. Christopher's Hospital for Children
First posted: 2012-12-10
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study's primary aim is to test the hypothesis that an intervention integrating pediatric clinic-level quality improvement with home-level behavioral counseling (CQI+BC) will result in greater reductions in child cotinine (a biomarker of secondhand smoke exposure) and reported cigarettes exposed/day than a clinic-level quality improvement plus attention control intervention (CQI+A). A secondary aim is to test the hypothesis that relative to CQI+A, CQI+BC will result in higher cotinine-verified, 7-day point prevalence quit rate among parents.

Detailed description: Child secondhand smoke exposure (SHSe) is a significant public health problem that has been linked to asthma, acute respiratory illnesses, otitis, and SIDS, and is associated with increased risk of cancers, cardiovascular disease, and behavior problems. This project will test the effectiveness of a comprehensive multilevel intervention to reduce young children's SHSe in minority and medically underserved communities known to have the highest SHSe-related morbidity and mortality risk. First, we will provide a clinic-level quality improvement (CQI) intervention to improve the care of pediatric patients with SHSe in four pediatric clinics in North and West Philadelphia. We will then randomize eligible parents visiting the CQI clinics into either a home-level behavioral counseling intervention (CQI+BC) or a home-level attention control intervention (CQI+A). In addition to clinic-level intervention, CQI+BC provides personalized, behavioral counseling with intensive skills training and support where SHSe occurs (in the home), as well as systems navigation to facilitate access to and effective use of reimbursable nicotine replacement therapy and smoking cessation medication. Participants will complete assessments at pre-treatment, 3-month end of treatment, and 12-month follow-up.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* English-speaking
* parent or legal guardian of child under 11 years old who lives with him/her
* daily smoker

Exclusion Criteria:

* non-nicotine drug dependence
* psychiatric disturbance (bipolar, schizophrenia, psychosis)
* pregnant
* inadequate health literacy

Primary outcomes:
measure: Child Urine Cotinine
timeFrame: up to 12 months
measure: Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources
timeFrame: up to 12 months
Secondary outcomes:
measure: Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadephia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital System
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Brad Collins, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Stephen Lepore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lepore SJ, Winickoff JP, Moughan B, Bryant-Stephens TC, Taylor DR, Fleece D, Davey A, Nair US, Godfrey M, Collins BN. Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children. BMC Public Health. 2013 Aug 30;13:792. doi: 10.1186/1471-2458-13-792.
citation: Collins BN, Lepore SJ, Winickoff JP, Nair US, Moughan B, Bryant-Stephens T, Davey A, Taylor D, Fleece D, Godfrey M. An Office-Initiated Multilevel Intervention for Tobacco Smoke Exposure: A Randomized Trial. Pediatrics. 2018 Jan;141(Suppl 1):S75-S86. doi: 10.1542/peds.2017-1026K.
citation: Collins BN, Lepore SJ, Winickoff JP, Sosnowski DW. Parents' Self-efficacy for Tobacco Exposure Protection and Smoking Abstinence Mediate Treatment Effects on Child Cotinine at 12-Month Follow-up: Mediation Results from the Kids Safe and Smokefree Trial. Nicotine Tob Res. 2020 Oct 29;22(11):1981-1988. doi: 10.1093/ntr/ntz175.
citation: Lepore SJ, Collins BN, Sosnowski DW. Self-efficacy as a pathway to long-term smoking cessation among low-income parents in the multilevel Kids Safe and Smokefree intervention. Drug Alcohol Depend. 2019 Nov 1;204:107496. doi: 10.1016/j.drugalcdep.2019.05.027. Epub 2019 Aug 24.