Kids Safe and Smokefree (KiSS) (KiSS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|