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Clinical Trials/NCT01745393
NCT01745393
Completed
N/A

Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children

Temple University4 sites in 1 country327 target enrollmentMarch 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Second Hand Tobacco Smoke
Sponsor
Temple University
Enrollment
327
Locations
4
Primary Endpoint
Child Urine Cotinine
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
June 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)
  • inadequate health literacy

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence(up to 12 months)

Study Sites (4)

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