Kids Safe and Smokefree (KiSS) (KiSS)

July 10, 2018 updated by: Temple University

Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

327

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19122
        • Temple University
      • Philadelphia, Pennsylvania, United States, 19134
        • St. Christopher's Hospital for Children
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadephia
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 months
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.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Collaborators

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

Investigators

  • Principal Investigator: Brad Collins, PhD, Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

December 7, 2012

First Posted (Estimate)

December 10, 2012

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

July 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01CA158361 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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