Kids Safe and Smokefree (KiSS)

Nicotine Dependence Clinical Trial

— KiSS  

Official title:

Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745393
• Other study ID #: R01CA158361
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: June 2016

Study information

• Verified date: July 2018
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Second Hand Tobacco Smoke
• Tobacco Use Disorder

Intervention

Behavioral:
• Clinic Quality Improvement + Behavioral Counseling

• Clinic Quality Improvement + Attention Control

Locations

Country	Name	City	State
United States	Children's Hospital of Philadephia	Philadelphia	Pennsylvania
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania
United States	Temple University Hospital System	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Temple University	Children's Hospital of Philadelphia, St. Christopher's Hospital for Children

Country where clinical trial is conducted

United States, 

References & Publications (2)

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: — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Urine Cotinine	Child urine cotinine is a biomarker for assessing second-hand smoke exposure. We anticipate the CQI+BC treatment group will experience a greater reduction in child urine cotinine over time than the CQI+A control group.	up to 12 months
Primary	Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources	Parental report of cigarettes child is exposed to each day in the home and car by all sources during the 7 days prior to assessment. We anticipate the CQI+BC treatment group will report greater reductions in second-hand smoke exposure over time than the CQI+A control group.	up to 12 months
Secondary	Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence	When a participant reports smoking abstinence, we will bioverify their smoking status.	up to 12 months