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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
| St. Christopher's Hospital for Children | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinic Quality Improvement + Behavioral Counseling | Behavioral |
| ||
| Clinic Quality Improvement + Attention Control |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence | When a participant reports smoking abstinence, we will bioverify their smoking status. | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brad Collins, PhD | Temple University | Principal Investigator |
| Stephen Lepore, PhD | Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadephia | Philadelphia | Pennsylvania | 19104 | United States | ||
| Temple University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23987302 | Result | 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. | |
| 29292308 | Result | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment to End-of-treatment Assessment |
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| 12-month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | log transformed ng/mL | up to 12 months | urine cotinine samples | urine cotinine samples |
|
1 year (from enrollment to 12-month follow-up assessment)
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bradley Collins | Temple University | 215-204-2849 | collinsb@temple.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Behavioral |
|
| Philadelphia |
| Pennsylvania |
| 19122 |
| United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
| Temple University Hospital System | Philadelphia | Pennsylvania | 19140 | United States |
| 37107735 | Derived | 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. |
| 31536116 | Derived | 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. |
| 31499240 | Derived | 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. |
| NOT COMPLETED |
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| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| married, living with partner | Count of Participants | Participants |
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| less than high school education | Count of Participants | Participants |
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| income below poverty level | Count of Participants | Participants |
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| child age | measured in months | Mean | Standard Deviation | months |
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| parents' cigarettes per day smoked | Mean | Standard Deviation | cigarettes smoked per day |
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| child (log) cotinine | Mean | Standard Deviation | log transformed ng/mL |
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| OG001 | 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 |
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| Primary | 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. | Posted | Mean | Standard Deviation | cigarettes exposed per day | up to 12 months |
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| Secondary | Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence | When a participant reports smoking abstinence, we will bioverify their smoking status. | Posted | Count of Participants | Participants | up to 12 months |
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|
| 0 |
| 163 |
| 0 |
| 163 |
| 0 |
| 163 |
| EG001 | 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 | 0 | 164 | 0 | 164 | 0 | 164 |
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| D001519 | Behavior |