Kids Safe and Smokefree (KiSS) (KiSS)
|ClinicalTrials.gov Identifier: NCT01745393|
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : August 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Second Hand Tobacco Smoke Nicotine Dependence||Behavioral: Clinic Quality Improvement + Behavioral Counseling Behavioral: Clinic Quality Improvement + Attention Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||325 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
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|
- 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 [ 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.
- Parent-reported cotinine-verified 7-day point prevalence abstinence [ Time Frame: 7 days prior to 12 week and 12 month assessments ]When a participant reports smoking abstinence, we will bioverify their smoking status.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745393
|United States, Pennsylvania|
|Children's Hospital of Philadephia|
|Philadelphia, Pennsylvania, United States, 19104|
|Philadelphia, Pennsylvania, United States, 19122|
|St. Christopher's Hospital for Children|
|Philadelphia, Pennsylvania, United States, 19134|
|Temple University Hospital System|
|Philadelphia, Pennsylvania, United States, 19140|
|Principal Investigator:||Brad Collins, PhD||Temple University|
|Principal Investigator:||Stephen Lepore, PhD||Temple University|