Trials / Completed
CompletedNCT01745393
Kids Safe and Smokefree (KiSS)
Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 327 (actual)
- Sponsor
- Temple University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Clinic Quality Improvement + Behavioral Counseling | |
| BEHAVIORAL | Clinic Quality Improvement + Attention Control |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2012-12-10
- Last updated
- 2018-08-08
- Results posted
- 2018-08-08
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01745393. Inclusion in this directory is not an endorsement.