Kids Safe and Smokefree (KiSS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Temple University
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
St. Christopher's Hospital for Children
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT01745393
First received: November 12, 2012
Last updated: December 7, 2012
Last verified: November 2012
  Purpose

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 Intervention
Tobacco Smoke Pollution
Nicotine Dependence
Behavioral: Clinic Quality Improvement + Behavioral Counseling (CQI+BC)
Behavioral: Clinic Quality Improvement + Attention Control (CQI+A)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • Child urine cotinine [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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:
  • Parent-reported cotinine-verified 7-day point prevalence abstinence [ Time Frame: 7 days prior to 12 week and 12 month assessments ] [ Designated as safety issue: Yes ]
    When a participant reports smoking abstinence, we will bioverify their smoking status.


Estimated Enrollment: 350
Study Start Date: March 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clinic Quality Improvement + Behavioral Counseling (CQI+BC)
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 (CQI+BC)
Active Comparator: Clinic Quality Improvement + Attention Control (CQI+A)
The attention control intervention parallels the format of the CQI+BC 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 (CQI+A)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745393

Contacts
Contact: Brad Collins, PhD 215-204-2849 collinsb@temple.edu
Contact: Melissa Godfrey, MPH 215-204-0315 melissa.godfrey@temple.edu

Locations
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19122
Contact: Brad Collins, PhD    215-204-2849      
Principal Investigator: Brad Collins, PhD         
Principal Investigator: Stephen Lepore, PhD         
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Daniel Taylor, MD    215-817-1149    daniel.taylor@drexelmed.edu   
Sub-Investigator: Daniel Taylor, MD         
Children's Hospital of Philadephia Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Temple University Hospital System Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Beth Moughan, MD    251-370-7556    beth.moughan@tuhs.temple.edu   
Sub-Investigator: Beth Moughan, MD         
Sponsors and Collaborators
Temple University
Children's Hospital of Philadelphia
St. Christopher's Hospital for Children
Investigators
Principal Investigator: Brad Collins, PhD Temple University
Principal Investigator: Stephen Lepore, PhD Temple University
  More Information

No publications provided by Temple University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01745393     History of Changes
Other Study ID Numbers: R01CA158361
Study First Received: November 12, 2012
Last Updated: December 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
Smoking Cessation
Secondhand Smoke
Passive Smoking
Cotinine
Nicotine Replacement Products

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014