An Intervention to Reduce Second Hand Smoke Exposure Among Pediatric Emergency Patients

NCT02531594 | Completed Results DMC

• 3 other identifiers: CINC 2015-19141R01HD083354R01ES027815
• Study Type: interventional
• Target: 770
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the efficacy of a cessation intervention for caregivers in a large, inner-city Pediatric Emergency Department. The investigators will randomize 750 caregivers who smoke who present to our Pediatric Emergency Department with their child who has a Second Hand Smoke exposure-related illness to either one of two conditions: 1) Screening, Brief Intervention, and Assisted Referral to Treatment (SBIRT); or 2) Healthy Habits Control (HHC). The Screening, Brief Intervention, and Assisted Referral to Treatment condition will include a brief form of the Clinical Practice Guideline: Treating Tobacco Use and Dependence, motivational interviewing, engaging and personalized materials on the effects of smoking and Second Hand Smoke exposure, immediate access to caregivers' choice of cessation resources (e.g., Quitline, smokefree.gov, or txt2quit), a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks. The Healthy Habits Control program will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve the child's health.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Self-reported Prolonged Abstinence at 6 Weeks

  Primary outcomes are self-reported prolonged abstinence at 6-weeks post-enrollment, validated in all participants via salivary cotinine levels.

  6 weeks post enrollment

• Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months

  Primary outcomes are self-reported prolonged abstinence at 6 months post-enrollment, validated in all participants via salivary cotinine levels.

  6months post enrollment

Secondary Outcomes (8)

• Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Weeks

  baseline and 6 weeks post enrollment

• Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Months

  baseline and 6 months post enrollment

• Number of Quit Attempts at 6 Weeks

  6 weeks post enrollment

• Number of Quit Attempts at 6 Months

  6 months post enrollment

• Readiness to Quit at 6 Weeks

  6 weeks post enrollment

Study Arms (2)

SBIRT

EXPERIMENTAL

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

Behavioral: SBIRT

HHC

PLACEBO COMPARATOR

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.

Behavioral: HHC

Interventions

SBIRT BEHAVIORAL

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.

SBIRT

HHC BEHAVIORAL

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.

HHC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• be \> age 18;
• 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
• be a daily smoker;
• have currently or recently smoked inside their home;
• speak and read English, and
• have a permanent address and a working cell or landline number.
• Live within a 50 mile radius.
• Child is a non-smoker.

You may not qualify if:

• their child has a tracheostomy or
• if the caregivers are tobacco chewers only,
• if the caregivers are using pharmacologic cessation treatment,
• or plan to move within the study period.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (8)

• 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.

  PMID: 28464887 BACKGROUND

• 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.

  PMID: 33158230 RESULT

• 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.

  PMID: 31766400 RESULT

• 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.

  PMID: 31258335 RESULT

• 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.

  PMID: 32760865 RESULT

• 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.

  PMID: 32059566 RESULT

• 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.

  PMID: 31046729 DERIVED

• 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.

  PMID: 28360145 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Limitations and Caveats

It should be noted that outcome measure "Use of Cessation Resources at 6 Months" was not reported due to no data being obtained due to lack of resources.

Results Point of Contact

• Title: Dr. Melinda Mahabee-Gittens
• Organization: Cincinnati Children's Hospital Medical Center

melinda.mahabee-gittens@cchmc.org

513-636-7966

Study Officials

• E. Melinda Mahabee-Gittens, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 24, 2015
• Study Start: April 6, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: September 15, 2023
• Results First Posted: October 4, 2022

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)