Trial Outcomes & Findings for Kids Safe and Smokefree (KiSS) (NCT NCT01745393)

Last Updated: 2018-08-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

327 participants

Primary outcome timeframe

up to 12 months

Results posted on

2018-08-08

Participant Flow

Pre-assignment clinic-level intervention and referral (recruitment): Across five pediatric primary care clinics in Philadelphia's three largest pediatric health systems (Temple University, Drexel University, and Children's Hospital of Philadelphia), 334 providers conducted the Ask, Advise, Refer clinic-level treatment implemented for this study.

Providers referred 2949 parents to the trial: 1280 were not eligible, 598 declined participation, 702 could not be contacted. Of 369 at baseline, 369 completed self-report assessments; 42 did not complete the pre-randomization home-visit child urine (cotinine) pick-up. Thus, 327 participants were randomized between the two treatment conditions.

Participant milestones

Participant milestones
Measure	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. Clinic Quality Improvement + Behavioral Counseling	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. Clinic Quality Improvement + Attention Control
Treatment to End-of-treatment Assessment STARTED	163	164
Treatment to End-of-treatment Assessment Received Treatment	147	144
Treatment to End-of-treatment Assessment COMPLETED	142	156
Treatment to End-of-treatment Assessment NOT COMPLETED	21	8
12-month Follow-up STARTED	142	156
12-month Follow-up COMPLETED	136	151
12-month Follow-up NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Clinic Quality Improvement + Behavioral Counseling	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. Clinic Quality Improvement + Attention Control
Treatment to End-of-treatment Assessment Lost to Follow-up	20	8
Treatment to End-of-treatment Assessment Withdrawal by Subject	1	0
12-month Follow-up Lost to Follow-up	6	5

Baseline Characteristics

Kids Safe and Smokefree (KiSS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clinic Quality Improvement + Behavioral Counseling n=163 Participants 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. Clinic Quality Improvement + Behavioral Counseling	Clinic Quality Improvement + Attention Control n=164 Participants 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. Clinic Quality Improvement + Attention Control	Total n=327 Participants Total of all reporting groups
Age, Continuous	32.74 years STANDARD_DEVIATION 7.94 • n=5 Participants	33.88 years STANDARD_DEVIATION 9.20 • n=7 Participants	33.31 years STANDARD_DEVIATION 8.60 • n=5 Participants
Sex: Female, Male Female	140 Participants n=5 Participants	133 Participants n=7 Participants	273 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	31 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	134 Participants n=5 Participants	138 Participants n=7 Participants	272 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	163 participants n=5 Participants	164 participants n=7 Participants	327 participants n=5 Participants
married, living with partner	71 Participants n=5 Participants	63 Participants n=7 Participants	134 Participants n=5 Participants
less than high school education	43 Participants n=5 Participants	46 Participants n=7 Participants	89 Participants n=5 Participants
income below poverty level	128 Participants n=5 Participants	129 Participants n=7 Participants	257 Participants n=5 Participants
child age	64.53 months STANDARD_DEVIATION 31.59 • n=5 Participants	64.04 months STANDARD_DEVIATION 33.87 • n=7 Participants	64.29 months STANDARD_DEVIATION 32.70 • n=5 Participants
parents' cigarettes per day smoked	12.18 cigarettes smoked per day STANDARD_DEVIATION 8.92 • n=5 Participants	10.72 cigarettes smoked per day STANDARD_DEVIATION 5.84 • n=7 Participants	11.45 cigarettes smoked per day STANDARD_DEVIATION 7.56 • n=5 Participants
child (log) cotinine	1.17 log transformed ng/mL STANDARD_DEVIATION 0.53 • n=5 Participants	1.24 log transformed ng/mL STANDARD_DEVIATION 0.50 • n=7 Participants	1.21 log transformed ng/mL STANDARD_DEVIATION 0.52 • n=5 Participants

PRIMARY outcome

Timeframe: up to 12 months

Population: The fewer number of units analyzed compared to participants analyzed relates to completion of telephone assessments for all participants, but inability to collect 5 urine samples in the Behavioral Counseling group and 2 urine samples in the Attention Control group at the post-phone assessment urine pickup at participants' homes.

Outcome measures

Outcome measures
Measure	Clinic Quality Improvement + Behavioral Counseling n=131 urine cotinine samples 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. Clinic Quality Improvement + Behavioral Counseling	Clinic Quality Improvement + Attention Control n=149 urine cotinine samples 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. Clinic Quality Improvement + Attention Control
Child Urine Cotinine	0.892 log transformed ng/mL Standard Deviation 0.65	0.891 log transformed ng/mL Standard Deviation 0.58

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Clinic Quality Improvement + Behavioral Counseling n=136 Participants 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. Clinic Quality Improvement + Behavioral Counseling	Clinic Quality Improvement + Attention Control n=151 Participants 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. Clinic Quality Improvement + Attention Control
Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources	3.8 cigarettes exposed per day Standard Deviation 5.52	3.04 cigarettes exposed per day Standard Deviation 3.84

SECONDARY outcome

Timeframe: up to 12 months

When a participant reports smoking abstinence, we will bioverify their smoking status.

Outcome measures

Outcome measures
Measure	Clinic Quality Improvement + Behavioral Counseling n=132 Participants 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. Clinic Quality Improvement + Behavioral Counseling	Clinic Quality Improvement + Attention Control n=149 Participants 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. Clinic Quality Improvement + Attention Control
Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence	20 Participants	10 Participants

Adverse Events

Clinic Quality Improvement + Behavioral Counseling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clinic Quality Improvement + Attention Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bradley Collins

Temple University

Phone: 215-204-2849

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place