Kids Safe and Smokefree (KiSS)

Temple University

Status: Completed

Conditions: Nicotine Dependence; Second Hand Tobacco Smoke

Treatments: Behavioral: Clinic Quality Improvement + Attention Control; Behavioral: Clinic Quality Improvement + Behavioral Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01745393

R01CA158361

Details and patient eligibility

About

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.

Full 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.

Enrollment: 327 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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327 participants in 2 patient groups

Clinic Quality Improvement + Behavioral Counseling

Experimental group

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.

Treatment:

Behavioral: Clinic Quality Improvement + Behavioral Counseling

Clinic Quality Improvement + Attention Control

Active Comparator group

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.

Treatment:

Behavioral: Clinic Quality Improvement + Attention Control