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Kids Safe and Smokefree (KiSS) (KiSS)

Primary Purpose

Second Hand Tobacco Smoke, Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinic Quality Improvement + Behavioral Counseling
Clinic Quality Improvement + Attention Control
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Second Hand Tobacco Smoke focused on measuring Smoking Cessation, Secondhand Smoke, Passive Smoking, Cotinine, Nicotine Replacement Products

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Philadephia
  • Temple University
  • St. Christopher's Hospital for Children
  • Temple University Hospital System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clinic Quality Improvement + Behavioral Counseling

Clinic Quality Improvement + Attention Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
November 12, 2012
Last Updated
July 10, 2018
Sponsor
Temple University
Collaborators
Children's Hospital of Philadelphia, St. Christopher's Hospital for Children
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1. Study Identification

Unique Protocol Identification Number
NCT01745393
Brief Title
Kids Safe and Smokefree (KiSS)
Acronym
KiSS
Official Title
Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
Children's Hospital of Philadelphia, St. Christopher's Hospital for Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Second Hand Tobacco Smoke, Nicotine Dependence
Keywords
Smoking Cessation, Secondhand Smoke, Passive Smoking, Cotinine, Nicotine Replacement Products

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinic Quality Improvement + Behavioral Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Clinic Quality Improvement + Attention Control
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Clinic Quality Improvement + Behavioral Counseling
Intervention Type
Behavioral
Intervention Name(s)
Clinic Quality Improvement + Attention Control
Primary Outcome Measure Information:
Title
Child Urine Cotinine
Description
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.
Time Frame
up to 12 months
Title
Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources
Description
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.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence
Description
When a participant reports smoking abstinence, we will bioverify their smoking status.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad Collins, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Lepore, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadephia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Temple University Hospital System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23987302
Citation
Lepore SJ, Winickoff JP, Moughan B, Bryant-Stephens TC, Taylor DR, Fleece D, Davey A, Nair US, Godfrey M, Collins BN. Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children. BMC Public Health. 2013 Aug 30;13:792. doi: 10.1186/1471-2458-13-792.
Results Reference
result
PubMed Identifier
29292308
Citation
Collins BN, Lepore SJ, Winickoff JP, Nair US, Moughan B, Bryant-Stephens T, Davey A, Taylor D, Fleece D, Godfrey M. An Office-Initiated Multilevel Intervention for Tobacco Smoke Exposure: A Randomized Trial. Pediatrics. 2018 Jan;141(Suppl 1):S75-S86. doi: 10.1542/peds.2017-1026K. Erratum In: Pediatrics. 2018 Jun;141(6):
Results Reference
result
PubMed Identifier
31536116
Citation
Collins BN, Lepore SJ, Winickoff JP, Sosnowski DW. Parents' Self-efficacy for Tobacco Exposure Protection and Smoking Abstinence Mediate Treatment Effects on Child Cotinine at 12-Month Follow-up: Mediation Results from the Kids Safe and Smokefree Trial. Nicotine Tob Res. 2020 Oct 29;22(11):1981-1988. doi: 10.1093/ntr/ntz175.
Results Reference
derived
PubMed Identifier
31499240
Citation
Lepore SJ, Collins BN, Sosnowski DW. Self-efficacy as a pathway to long-term smoking cessation among low-income parents in the multilevel Kids Safe and Smokefree intervention. Drug Alcohol Depend. 2019 Nov 1;204:107496. doi: 10.1016/j.drugalcdep.2019.05.027. Epub 2019 Aug 24.
Results Reference
derived

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Kids Safe and Smokefree (KiSS)

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