Kids Safe and Smokefree (KiSS)

Not Applicable

Completed

• Conditions: Nicotine Dependence; Second Hand Tobacco Smoke
• Interventions: Behavioral: Clinic Quality Improvement + Behavioral Counseling; Behavioral: Clinic Quality Improvement + Attention Control

• Registration Number: NCT01745393
• Lead Sponsor: Temple University

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-11-12
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2018-05-29
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-10
• Last Update Submitted: 2018-07-10
• Results First Posted: 2018-08-08
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinic Quality Improvement + Behavioral Counseling	Clinic Quality Improvement + Behavioral Counseling	This multilevel intervention includes advice and a referral from a pediatrician, behavioral counseling by study staff, and community systems navigation, all designed to reduce pediatric secondhand smoke exposure. Over the course of 12 weeks participants receive a home visit designed to orient them to the program and trained health counselors provide multiple individualized phone counseling sessions designed to build coping skills, urge management skills, and self-efficacy. Counseling also includes assistance with goal setting and navigation of local resources.
Clinic Quality Improvement + Attention Control	Clinic Quality Improvement + Attention Control	The attention control intervention parallels the format of the experimental group but focuses on family nutrition information. The intervention includes a home visit to orient the participant to the program and multiple phone counseling sessions conducted by a trained health counselor.

Primary Outcome Measures

Name	Time	Method
Child Urine Cotinine	up to 12 months	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.
Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources	up to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence	up to 12 months	When a participant reports smoking abstinence, we will bioverify their smoking status.

Trial Locations

Locations (4)

Temple University Hospital System; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hospital of Philadephia; 🇺🇸 Philadelphia, Pennsylvania, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

St. Christopher's Hospital for Children; 🇺🇸 Philadelphia, Pennsylvania, United States