Second Hand Tobacco SmokeKiSSNCT01745393

Kids Safe and Smokefree (KiSS)

A study testing Clinic Quality Improvement + Behavioral Counseling in people with Second Hand Tobacco Smoke and Nicotine Dependence, run by Temple University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Second Hand Tobacco Smoke, Nicotine Dependence
What is being tested?: Clinic Quality Improvement + Behavioral Counseling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 327 participants
Where: 4 sitesUnited States
Study dates: Mar 2012to Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

non-nicotine drug dependence
psychiatric disturbance (bipolar, schizophrenia, psychosis)
pregnant
inadequate health literacy

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Children's Hospital of Philadephia
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19122
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Temple University Hospital System
Philadelphia, Pennsylvania, 19140

Other trials in United States

About this study

Official title: Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children

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.

Read the detailed 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.

Conditions: Second Hand Tobacco Smoke, Nicotine Dependence
Being tested: Clinic Quality Improvement + Behavioral Counseling, Clinic Quality Improvement + Attention Control
Keywords: Smoking Cessation, Secondhand Smoke, Passive Smoking, Cotinine, Nicotine Replacement Products
Medical subject headings: Tobacco Use Disorder, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clinic Quality Improvement + Behavioral CounselingBehavioural
Clinic Quality Improvement + Attention ControlBehavioural

Study groups in NCT01745393
Study group	Role	What they receive
Clinic Quality Improvement + Behavioral Counseling	Experimental	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. Receives: Behavioral: Clinic Quality Improvement + Behavioral Counseling
Clinic Quality Improvement + Attention Control	Active comparator	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. Receives: Behavioral: Clinic Quality Improvement + Attention Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Child Urine Cotinine
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.
Measured: up to 12 months
Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources
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.
Measured: up to 12 months

Secondary outcomes (1)

Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence
When a participant reports smoking abstinence, we will bioverify their smoking status.
Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Jun 2016

First posted10 Dec 2012 (estimated)
Study startMar 2012
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Second Hand Tobacco SmokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 327 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01745393
Sponsor's protocol ID: R01CA158361
Acronym: KiSS
Status last verified: Jul 2018
First submitted: 12 Nov 2012
Last updated: 8 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Lepore SJ, Winickoff JP, Moughan B, Bryant-Stephens TC, Taylor DR, Fleece D, Davey A, Nair US, Godfrey M, Collins BN. Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children. BMC Public Health. 2013 Aug 30;13:792. doi: 10.1186/1471-2458-13-792.
PubMed 23987302
Collins BN, Lepore SJ, Winickoff JP, Nair US, Moughan B, Bryant-Stephens T, Davey A, Taylor D, Fleece D, Godfrey M. An Office-Initiated Multilevel Intervention for Tobacco Smoke Exposure: A Randomized Trial. Pediatrics. 2018 Jan;141(Suppl 1):S75-S86. doi: 10.1542/peds.2017-1026K.
PubMed 29292308
Chin SM, Lepore SJ, Collins BN, Dumenci L, Rincon MA. Validation and Psychometric Properties of the Tobacco Urge Management Scale (TUMS). Int J Environ Res Public Health. 2023 Apr 10;20(8):5453. doi: 10.3390/ijerph20085453.
PubMed 37107735
Collins BN, Lepore SJ, Winickoff JP, Sosnowski DW. Parents' Self-efficacy for Tobacco Exposure Protection and Smoking Abstinence Mediate Treatment Effects on Child Cotinine at 12-Month Follow-up: Mediation Results from the Kids Safe and Smokefree Trial. Nicotine Tob Res. 2020 Oct 29;22(11):1981-1988. doi: 10.1093/ntr/ntz175.
PubMed 31536116
Lepore SJ, Collins BN, Sosnowski DW. Self-efficacy as a pathway to long-term smoking cessation among low-income parents in the multilevel Kids Safe and Smokefree intervention. Drug Alcohol Depend. 2019 Nov 1;204:107496. doi: 10.1016/j.drugalcdep.2019.05.027. Epub 2019 Aug 24.
PubMed 31499240

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network
Smoking, Smoking Cessation
Recruiting
The "Quit-for-Kids" Project: to Increase Abstinence and Protect Children From Tobacco Smoke Exposure
Smoking Cessation, Second Hand Tobacco Smoke
Recruiting
Implementing a Scalable Smoke-free Home Intervention in Armenia and Georgia
Second Hand Tobacco Smoke
Enrolling by invitation
Enhancing Equity in Smoke-free Housing
Tobacco Use, Tobacco Smoking

All Second Hand Tobacco Smoke trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children
ClinicalTrials.gov ID: NCT01745393
Acronym / sponsor ID: KiSS / R01CA158361
Conditions: Second Hand Tobacco Smoke, Nicotine Dependence
Keywords: Smoking Cessation, Secondhand Smoke, Passive Smoking, Cotinine, Nicotine Replacement Products
Study type: Interventional
Recruitment status: Completed
Enrolment: 327 participants (actual)
Lead sponsor: Temple UniversityUniversity, hospital or other
Collaborators: Children's Hospital of Philadelphia, St. Christopher's Hospital for Children
Study start: Mar 2012
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 10 Dec 2012 (estimated)
Results: Posted 8 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Clinic Quality Improvement + Behavioral Counseling	Experimental	Behavioral: Clinic Quality Improvement + Behavioral CounselingThis 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 + Attention Control	Active comparator	Behavioral: Clinic Quality Improvement + Attention ControlThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

non-nicotine drug dependence
psychiatric disturbance (bipolar, schizophrenia, psychosis)
pregnant
inadequate health literacy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clinic Quality Improvement + Behavioral Counseling	Behavioural	Clinic Quality Improvement + Behavioral Counseling
Clinic Quality Improvement + Attention Control	Behavioural	Clinic Quality Improvement + Attention Control

Primary outcome

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 From All Sources
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.

1 secondary outcome

Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence
Time frame: up to 12 months

Results and safety

Results posted to the registry on 8 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clinic Quality Improvement + Behavioral Counseling	163	142
Clinic Quality Improvement + Attention Control	164	156

Primary outcome: Child Urine Cotinine

Time frame: up to 12 months. Mean (Standard Deviation). Unit: log transformed ng/mL

Measure	Clinic Quality Improvement + Behavioral Counseling n = 136	Clinic Quality Improvement + Attention Control n = 151
Value	0.892 (0.65)	0.891 (0.58)

Population analysed: 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.

Primary outcome: Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources

Time frame: up to 12 months. Mean (Standard Deviation). Unit: cigarettes exposed per day

Measure	Clinic Quality Improvement + Behavioral Counseling n = 136	Clinic Quality Improvement + Attention Control n = 151
Value	3.8 (5.52)	3.04 (3.84)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year (from enrollment to 12-month follow-up assessment). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clinic Quality Improvement + Behavioral Counseling	0 of 163 (0%)	0 of 163 (0%)	0 of 163
Clinic Quality Improvement + Attention Control	0 of 164 (0%)	0 of 164 (0%)	0 of 164

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23987302Lepore SJ, Winickoff JP, Moughan B, Bryant-Stephens TC, Taylor DR, Fleece D, Davey A, Nair US, Godfrey M, Collins BN. Kids Safe and Smokefree (KiSS): a randomized controlled trial of a multilevel intervention to reduce secondhand tobacco smoke exposure in children. BMC Public Health. 2013 Aug 30;13:792. doi: 10.1186/1471-2458-13-792.
Results publication: PubMed 29292308Collins BN, Lepore SJ, Winickoff JP, Nair US, Moughan B, Bryant-Stephens T, Davey A, Taylor D, Fleece D, Godfrey M. An Office-Initiated Multilevel Intervention for Tobacco Smoke Exposure: A Randomized Trial. Pediatrics. 2018 Jan;141(Suppl 1):S75-S86. doi: 10.1542/peds.2017-1026K.
Derived from this study: PubMed 37107735Chin SM, Lepore SJ, Collins BN, Dumenci L, Rincon MA. Validation and Psychometric Properties of the Tobacco Urge Management Scale (TUMS). Int J Environ Res Public Health. 2023 Apr 10;20(8):5453. doi: 10.3390/ijerph20085453.
Derived from this study: PubMed 31536116Collins BN, Lepore SJ, Winickoff JP, Sosnowski DW. Parents' Self-efficacy for Tobacco Exposure Protection and Smoking Abstinence Mediate Treatment Effects on Child Cotinine at 12-Month Follow-up: Mediation Results from the Kids Safe and Smokefree Trial. Nicotine Tob Res. 2020 Oct 29;22(11):1981-1988. doi: 10.1093/ntr/ntz175.
Derived from this study: PubMed 31499240Lepore SJ, Collins BN, Sosnowski DW. Self-efficacy as a pathway to long-term smoking cessation among low-income parents in the multilevel Kids Safe and Smokefree intervention. Drug Alcohol Depend. 2019 Nov 1;204:107496. doi: 10.1016/j.drugalcdep.2019.05.027. Epub 2019 Aug 24.

Related trials for Second Hand Tobacco Smoke

Recruiting
Refer2Quit: Evaluating a Proactive, Tailored, Population Health Approach for Tobacco Treatment for Household Smokers Through a Pediatric Care Network
Smoking, Smoking Cessation
Recruiting
The "Quit-for-Kids" Project: to Increase Abstinence and Protect Children From Tobacco Smoke Exposure
Smoking Cessation, Second Hand Tobacco Smoke
Recruiting
Implementing a Scalable Smoke-free Home Intervention in Armenia and Georgia
Second Hand Tobacco Smoke
Enrolling by invitation
Enhancing Equity in Smoke-free Housing
Tobacco Use, Tobacco Smoking

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brad Collins, PhD principal investigator

Temple University

Stephen Lepore, PhD principal investigator

Temple University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Clinic Quality Improvement + Behavioral Counseling in people with Second Hand Tobacco Smoke and Nicotine Dependence, run by Temple University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child Urine Cotinine (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01745393, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.