Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-02-26 @ 12:41 AM
Study NCT ID:
NCT01745393
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2012-11-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Kids Safe and Smokefree (KiSS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'collinsb@temple.edu', 'phone': '215-204-2849', 'title': 'Bradley Collins', 'organization': 'Temple University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year (from enrollment to 12-month follow-up assessment)', '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.", 'eventGroups': [{'id': 'EG000', 'title': 'Clinic Quality Improvement + Behavioral Counseling', '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.\n\nClinic Quality Improvement + Behavioral Counseling', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 163, 'otherNumAffected': 0, 'seriousNumAtRisk': 163, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Clinic Quality Improvement + Attention Control', 'description': '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.\n\nClinic Quality Improvement + Attention Control', 'otherNumAtRisk': 164, 'deathsNumAtRisk': 164, 'otherNumAffected': 0, 'seriousNumAtRisk': 164, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Child Urine Cotinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}, {'units': 'urine cotinine samples', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinic Quality Improvement + Behavioral Counseling', '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.\n\nClinic Quality Improvement + Behavioral Counseling'}, {'id': 'OG001', 'title': 'Clinic Quality Improvement + Attention Control', 'description': '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.\n\nClinic Quality Improvement + Attention Control'}], 'classes': [{'categories': [{'measurements': [{'value': '0.892', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.891', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 12 months', '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.', 'unitOfMeasure': 'log transformed ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'urine cotinine samples', 'denomUnitsSelected': 'urine cotinine samples', 'populationDescription': "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."}, {'type': 'PRIMARY', 'title': 'Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinic Quality Improvement + Behavioral Counseling', '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.\n\nClinic Quality Improvement + Behavioral Counseling'}, {'id': 'OG001', 'title': 'Clinic Quality Improvement + Attention Control', 'description': '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.\n\nClinic Quality Improvement + Attention Control'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '5.52', 'groupId': 'OG000'}, {'value': '3.04', 'spread': '3.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 12 months', '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.', 'unitOfMeasure': 'cigarettes exposed per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinic Quality Improvement + Behavioral Counseling', '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.\n\nClinic Quality Improvement + Behavioral Counseling'}, {'id': 'OG001', 'title': 'Clinic Quality Improvement + Attention Control', 'description': '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.\n\nClinic Quality Improvement + Attention Control'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 months', 'description': 'When a participant reports smoking abstinence, we will bioverify their smoking status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clinic Quality Improvement + Behavioral Counseling', '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.\n\nClinic Quality Improvement + Behavioral Counseling'}, {'id': 'FG001', 'title': 'Clinic Quality Improvement + Attention Control', 'description': '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.\n\nClinic Quality Improvement + Attention Control'}], 'periods': [{'title': 'Treatment to End-of-treatment Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'Received Treatment', 'achievements': [{'comment': 'Behavioral counseling = TSE-reduction and cessation counseling via telephone', 'groupId': 'FG000', 'numSubjects': '147'}, {'comment': 'Attention control = nutrition education via telephone', 'groupId': 'FG001', 'numSubjects': '144'}]}, {'type': 'COMPLETED', 'comment': 'completed end-of-treatment assessments', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '12-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '156'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': "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.", 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Clinic Quality Improvement + Behavioral Counseling', '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.\n\nClinic Quality Improvement + Behavioral Counseling'}, {'id': 'BG001', 'title': 'Clinic Quality Improvement + Attention Control', 'description': '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.\n\nClinic Quality Improvement + Attention Control'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.74', 'spread': '7.94', 'groupId': 'BG000'}, {'value': '33.88', 'spread': '9.20', 'groupId': 'BG001'}, {'value': '33.31', 'spread': '8.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'married, living with partner', 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'less than high school education', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'income below poverty level', 'classes': [{'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'child age', 'classes': [{'categories': [{'measurements': [{'value': '64.53', 'spread': '31.59', 'groupId': 'BG000'}, {'value': '64.04', 'spread': '33.87', 'groupId': 'BG001'}, {'value': '64.29', 'spread': '32.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'measured in months', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "parents' cigarettes per day smoked", 'classes': [{'categories': [{'measurements': [{'value': '12.18', 'spread': '8.92', 'groupId': 'BG000'}, {'value': '10.72', 'spread': '5.84', 'groupId': 'BG001'}, {'value': '11.45', 'spread': '7.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes smoked per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'child (log) cotinine', 'classes': [{'categories': [{'measurements': [{'value': '1.17', 'spread': '0.53', 'groupId': 'BG000'}, {'value': '1.24', 'spread': '0.50', 'groupId': 'BG001'}, {'value': '1.21', 'spread': '0.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log transformed ng/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 327}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2012-11-12', 'resultsFirstSubmitDate': '2018-05-29', 'studyFirstSubmitQcDate': '2012-12-07', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-10', 'studyFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Urine Cotinine', 'timeFrame': 'up to 12 months', '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.'}, {'measure': 'Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources', 'timeFrame': 'up to 12 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence', 'timeFrame': 'up to 12 months', 'description': 'When a participant reports smoking abstinence, we will bioverify their smoking status.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Smoking Cessation', 'Secondhand Smoke', 'Passive Smoking', 'Cotinine', 'Nicotine Replacement Products'], 'conditions': ['Second Hand Tobacco Smoke', 'Nicotine Dependence']}, 'referencesModule': {'references': [{'pmid': '23987302', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '29292308', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '37107735', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '31536116', 'type': 'DERIVED', 'citation': "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."}, {'pmid': '31499240', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 18 years of age\n* English-speaking\n* parent or legal guardian of child under 11 years old who lives with him/her\n* daily smoker\n\nExclusion Criteria:\n\n* non-nicotine drug dependence\n* psychiatric disturbance (bipolar, schizophrenia, psychosis)\n* pregnant\n* inadequate health literacy'}, 'identificationModule': {'nctId': 'NCT01745393', 'acronym': 'KiSS', 'briefTitle': 'Kids Safe and Smokefree (KiSS)', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'Pediatrician Advice, Family Counseling & SHS Reduction for Underserved Children', 'orgStudyIdInfo': {'id': 'R01CA158361', 'link': 'https://reporter.nih.gov/quickSearch/R01CA158361', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinic Quality Improvement + Behavioral Counseling', '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.', 'interventionNames': ['Behavioral: Clinic Quality Improvement + Behavioral Counseling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clinic Quality Improvement + Attention Control', 'description': '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.', 'interventionNames': ['Behavioral: Clinic Quality Improvement + Attention Control']}], 'interventions': [{'name': 'Clinic Quality Improvement + Behavioral Counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Clinic Quality Improvement + Behavioral Counseling']}, {'name': 'Clinic Quality Improvement + Attention Control', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Clinic Quality Improvement + Attention Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadephia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19122', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19134', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Christopher's Hospital for Children", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Brad Collins, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temple University'}, {'name': 'Stephen Lepore, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Temple University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, {'name': "St. Christopher's Hospital for Children", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}