An Intervention to Reduce Second Hand Smoke Exposure Among Pediatric Emergency Patients
NCT ID: NCT02531594
Last Updated: 2023-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
770 participants
INTERVENTIONAL
2016-04-06
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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SBIRT
An assessment form, motivational interviewing, personalized educational materials, immediate access to cessation resources, a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks.
nicotine
SBIRT
The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
HHC
The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion.
HHC
The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
Interventions
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SBIRT
The Social Worker will provide caregivers with the brief (10-15 minute) "Advise, Assess, Assist" intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials.
HHC
The Social Worker will provide caregivers with the brief (10-15 minute) "Lets Go! 5-2-1-0" intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials.
Eligibility Criteria
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Inclusion Criteria
2. be accompanying a child 0-17 years of age who is presenting to the Pediatric Emergency Department with:
* a stable condition, that is, patients who are not critically ill and do not require immediate treatment and intervention by the Pediatric Emergency Department practitioner and
* a potentially Second Hand Smoke exposure related chief complaint (such as wheezing, difficulty breathing, cough) as outlined by the U.S. Surgeon General;45
3. be a daily smoker;
4. have currently or recently smoked inside their home;
5. speak and read English, and
6. have a permanent address and a working cell or landline number.
7. Live within a 50 mile radius.
8. Child is a non-smoker.
Exclusion Criteria
2. if the caregivers are tobacco chewers only,
3. if the caregivers are using pharmacologic cessation treatment,
4. or plan to move within the study period.
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Environmental Health Sciences (NIEHS)
NIH
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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E. Melinda Mahabee-Gittens, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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References
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Mahabee-Gittens EM, Ammerman RT, Khoury JC, Stone L, Meyers GT, Witry JK, Merianos AL, Mancuso TF, Stackpole KMW, Bennett BL, Akers L, Gordon JS. Healthy families: study protocol for a randomized controlled trial of a screening, brief intervention, and referral to treatment intervention for caregivers to reduce secondhand smoke exposure among pediatric emergency patients. BMC Public Health. 2017 May 2;17(1):374. doi: 10.1186/s12889-017-4278-8.
Mahabee-Gittens EM, Ammerman RT, Khoury JC, Tabangin ME, Ding L, Merianos AL, Stone L, Gordon JS. A Parental Smoking Cessation Intervention in the Pediatric Emergency Setting: A Randomized Trial. Int J Environ Res Public Health. 2020 Nov 4;17(21):8151. doi: 10.3390/ijerph17218151.
Mahabee-Gittens EM, Merianos AL, Fulkerson PC, Stone L, Matt GE. The Association of Environmental Tobacco Smoke Exposure and Inflammatory Markers in Hospitalized Children. Int J Environ Res Public Health. 2019 Nov 21;16(23):4625. doi: 10.3390/ijerph16234625.
Mahabee-Gittens EM, Merianos AL, Stone L, Tabangin ME, Khoury JC, Gordon JS. Tobacco Use Behaviors and Perceptions of Parental Smokers in the Emergency Department Setting. Tob Use Insights. 2019 Jun 19;12:1179173X19841392. doi: 10.1177/1179173X19841392. eCollection 2019.
Mahabee-Gittens EM, Merianos AL, Tabangin ME, Stone L, Gordon JS, Khoury JC. Provision of free nicotine replacement therapy to parental smokers in the pediatric emergency setting. Tob Prev Cessat. 2020 May 18;6:30. doi: 10.18332/tpc/119125. eCollection 2020.
Mahabee-Gittens EM, Mazzella MJ, Doucette JT, Merianos AL, Stone L, Wullenweber CA, A Busgang S, Matt GE. Comparison of Liquid Chromatography Mass Spectrometry and Enzyme-Linked Immunosorbent Assay Methods to Measure Salivary Cotinine Levels in Ill Children. Int J Environ Res Public Health. 2020 Feb 12;17(4):1157. doi: 10.3390/ijerph17041157.
Mahabee-Gittens EM, Matt GE, Hoh E, Quintana PJE, Stone L, Geraci MA, Wullenweber CA, Koutsounadis GN, Ruwe AG, Meyers GT, Zakrajsek MA, Witry JK, Merianos AL. Contribution of thirdhand smoke to overall tobacco smoke exposure in pediatric patients: study protocol. BMC Public Health. 2019 May 2;19(1):491. doi: 10.1186/s12889-019-6829-7.
Mahabee-Gittens EM, Merianos AL, Matt GE. Preliminary evidence that high levels of nicotine on children's hands may contribute to overall tobacco smoke exposure. Tob Control. 2018 Mar;27(2):217-219. doi: 10.1136/tobaccocontrol-2016-053602. Epub 2017 Mar 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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