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Completed

NCT Number: NCT01745393

Kids Safe and Smokefree (KiSS)

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.

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Key information

Conditions

Second Hand Tobacco Smoke Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Nicotine Dependence Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadephia, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinic Quality Improvement + Behavioral Counseling

Behavioral

Clinic Quality Improvement + Attention Control

Behavioral

Primary outcomes

  1. Child Urine Cotinine

    Time frame: 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.

  2. Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources

    Time frame: 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 outcomes

  1. Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence

    Time frame: up to 12 months

    When a participant reports smoking abstinence, we will bioverify their smoking status.

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • Children's Hospital of Philadelphia
  • St. Christopher's Hospital for Children

Registry information

Official study title

Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children

Acronym: KiSS

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 10, 2012
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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