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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

Tracking Information
First Submitted Date  ICMJE November 12, 2012
First Posted Date  ICMJE December 10, 2012
Results First Submitted Date  ICMJE May 29, 2018
Results First Posted Date  ICMJE August 8, 2018
Last Update Posted Date August 8, 2018
Study Start Date  ICMJE March 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
  • 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.
  • Parent-reported second-hand smoke exposure in cigarettes per day [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence [ Time Frame: 7 days prior to 12 week and 12 month assessments ]
When a participant reports smoking abstinence, we will bioverify their smoking status.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Kids Safe and Smokefree (KiSS)
Official Title  ICMJE Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Second Hand Tobacco Smoke
  • Nicotine Dependence
Intervention  ICMJE
  • Behavioral: Clinic Quality Improvement + Behavioral Counseling
  • Behavioral: Clinic Quality Improvement + Attention Control
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Clinic Quality Improvement + Attention Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2018)
327
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2012)
350
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01745393
Other Study ID Numbers  ICMJE R01CA158361( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Temple University
Study Sponsor  ICMJE Temple University
Collaborators  ICMJE
  • Children's Hospital of Philadelphia
  • St. Christopher's Hospital for Children
Investigators  ICMJE
Principal Investigator: Brad Collins, PhD Temple University
Principal Investigator: Stephen Lepore, PhD Temple University
PRS Account Temple University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP