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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
Results First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
St. Christopher's Hospital for Children
Information provided by (Responsible Party):
Temple University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Second Hand Tobacco Smoke
Nicotine Dependence
Interventions Behavioral: Clinic Quality Improvement + Behavioral Counseling
Behavioral: Clinic Quality Improvement + Attention Control
Enrollment 327
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Clinic Quality Improvement + Behavioral Counseling Clinic Quality Improvement + Attention Control
Hide Arm/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.

Clinic Quality Improvement + Behavioral Counseling

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

Period Title: Treatment to End-of-treatment Assessment
Started 163 164
Received Treatment 147 [1] 144 [2]
Completed [3] 142 156
Not Completed 21 8
Reason Not Completed
Lost to Follow-up             20             8
Withdrawal by Subject             1             0
[1]
Behavioral counseling = TSE-reduction and cessation counseling via telephone
[2]
Attention control = nutrition education via telephone
[3]
completed end-of-treatment assessments
Period Title: 12-month Follow-up
Started 142 156
Completed 136 151
Not Completed 6 5
Reason Not Completed
Lost to Follow-up             6             5
Arm/Group Title Clinic Quality Improvement + Behavioral Counseling Clinic Quality Improvement + Attention Control Total
Hide Arm/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.

Clinic Quality Improvement + Behavioral Counseling

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 of all reporting groups
Overall Number of Baseline Participants 163 164 327
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 163 participants 164 participants 327 participants
32.74  (7.94) 33.88  (9.20) 33.31  (8.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 164 participants 327 participants
Female
140
  85.9%
133
  81.1%
273
  83.5%
Male
23
  14.1%
31
  18.9%
54
  16.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 164 participants 327 participants
American Indian or Alaska Native
1
   0.6%
1
   0.6%
2
   0.6%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
134
  82.2%
138
  84.1%
272
  83.2%
White
9
   5.5%
9
   5.5%
18
   5.5%
More than one race
10
   6.1%
8
   4.9%
18
   5.5%
Unknown or Not Reported
9
   5.5%
8
   4.9%
17
   5.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 163 participants 164 participants 327 participants
163 164 327
married, living with partner  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 164 participants 327 participants
71
  43.6%
63
  38.4%
134
  41.0%
less than high school education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 164 participants 327 participants
43
  26.4%
46
  28.0%
89
  27.2%
income below poverty level  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 163 participants 164 participants 327 participants
128
  78.5%
129
  78.7%
257
  78.6%
child age   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 163 participants 164 participants 327 participants
64.53  (31.59) 64.04  (33.87) 64.29  (32.70)
[1]
Measure Description: measured in months
parents' cigarettes per day smoked  
Mean (Standard Deviation)
Unit of measure:  Cigarettes smoked per day
Number Analyzed 163 participants 164 participants 327 participants
12.18  (8.92) 10.72  (5.84) 11.45  (7.56)
child (log) cotinine  
Mean (Standard Deviation)
Unit of measure:  Log transformed ng/mL
Number Analyzed 163 participants 164 participants 327 participants
1.17  (0.53) 1.24  (0.50) 1.21  (0.52)
1.Primary Outcome
Title Child Urine Cotinine
Hide Description 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.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clinic Quality Improvement + Behavioral Counseling Clinic Quality Improvement + Attention Control
Hide Arm/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.

Clinic Quality Improvement + Behavioral Counseling

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

Overall Number of Participants Analyzed 136 151
Overall Number of Units Analyzed
Type of Units Analyzed: Urine cotinine samples
131 149
Mean (Standard Deviation)
Unit of Measure: log transformed ng/mL
0.892  (0.65) 0.891  (0.58)
2.Primary Outcome
Title Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources
Hide Description 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.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinic Quality Improvement + Behavioral Counseling Clinic Quality Improvement + Attention Control
Hide Arm/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.

Clinic Quality Improvement + Behavioral Counseling

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

Overall Number of Participants Analyzed 136 151
Mean (Standard Deviation)
Unit of Measure: cigarettes exposed per day
3.8  (5.52) 3.04  (3.84)
3.Secondary Outcome
Title Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence
Hide Description When a participant reports smoking abstinence, we will bioverify their smoking status.
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinic Quality Improvement + Behavioral Counseling Clinic Quality Improvement + Attention Control
Hide Arm/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.

Clinic Quality Improvement + Behavioral Counseling

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

Overall Number of Participants Analyzed 132 149
Measure Type: Count of Participants
Unit of Measure: Participants
20
  15.2%
10
   6.7%
Time Frame 1 year (from enrollment to 12-month follow-up assessment)
Adverse Event Reporting Description There were no serious adverse events anticipated in this behavioral counseling trial designed to help parents reduce children's exposure to secondhand smoke and help parents quit smoking. However, we did track adverse events.
 
Arm/Group Title Clinic Quality Improvement + Behavioral Counseling Clinic Quality Improvement + Attention Control
Hide Arm/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.

Clinic Quality Improvement + Behavioral Counseling

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

All-Cause Mortality
Clinic Quality Improvement + Behavioral Counseling Clinic Quality Improvement + Attention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/163 (0.00%)   0/164 (0.00%) 
Hide Serious Adverse Events
Clinic Quality Improvement + Behavioral Counseling Clinic Quality Improvement + Attention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/163 (0.00%)   0/164 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clinic Quality Improvement + Behavioral Counseling Clinic Quality Improvement + Attention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/163 (0.00%)   0/164 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bradley Collins
Organization: Temple University
Phone: 215-204-2849
EMail: collinsb@temple.edu
Layout table for additonal information
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01745393    
Other Study ID Numbers: R01CA158361 ( U.S. NIH Grant/Contract )
First Submitted: November 12, 2012
First Posted: December 10, 2012
Results First Submitted: May 29, 2018
Results First Posted: August 8, 2018
Last Update Posted: August 8, 2018