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Kids Safe and Smokefree (KiSS) (KiSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01745393
Recruitment Status : Completed
First Posted : December 10, 2012
Results First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
St. Christopher's Hospital for Children
Information provided by (Responsible Party):
Temple University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Second Hand Tobacco Smoke Nicotine Dependence Behavioral: Clinic Quality Improvement + Behavioral Counseling Behavioral: Clinic Quality Improvement + Attention Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children
Study Start Date : March 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: Clinic Quality Improvement + Behavioral Counseling
Active Comparator: 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.
 Behavioral: Clinic Quality Improvement + Attention Control


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745393


Locations
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United States, Pennsylvania
Children's Hospital of Philadephia
Philadelphia, Pennsylvania, United States, 19104
Temple University
Philadelphia, Pennsylvania, United States, 19122
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Temple University Hospital System
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Temple University
Children's Hospital of Philadelphia
St. Christopher's Hospital for Children
Investigators
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Principal Investigator: Brad Collins, PhD Temple University
Principal Investigator: Stephen Lepore, PhD Temple University
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01745393    
Other Study ID Numbers: R01CA158361 ( U.S. NIH Grant/Contract )
First Posted: December 10, 2012    Key Record Dates
Results First Posted: August 8, 2018
Last Update Posted: August 8, 2018
Last Verified: July 2018
Keywords provided by Temple University:
Smoking Cessation
Secondhand Smoke
Passive Smoking
Cotinine
Nicotine Replacement Products
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders