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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: SBIRT; Behavioral: HHC

Detailed Description

This study will test the efficacy of a cessation intervention for caregivers in a large, inner-city Pediatric Emergency Department. The proposed Screening, Brief Intervention, and Assisted Referral to Treatment will highlight the effects of Second Hand Smoke exposure on the child's health. 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; or 2) Healthy Habits Control. The Screening, Brief Intervention, and Assisted Referral to Treatment condition will use components shown to be effective in the out-patient setting but not yet tested in the Pediatric Emergency Department setting. It 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 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. If effective, the Screening, Brief Intervention, and Assisted Referral to Treatment model could be routinely used in the Pediatric Emergency Department setting, which could reach at least one million smokers a year, and could result in significant reductions in caregivers' tobacco use, Second Hand Smoke exposure related pediatric illness, and costs in this population. In addition, the investigators' results will inform the conduct of public health research efforts aimed at adults via the Pediatric Emergency Department.

• Study Type: Interventional
• Enrollment (Actual): 770
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:Eligible participants must:

1. be > age 18;

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: Caregivers will be excluded if

1. their child has a tracheostomy or
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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.
Placebo Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Weeks	Secondary outcomes include number of cigarettes smoked at 6 weeks post enrollment. This number is reporting a change in the number of cigarettes smoked between baseline and six weeks.	baseline and 6 weeks post enrollment
Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Months	Secondary outcomes include number of cigarettes smoked at 6 months post enrollment as compared with baseline.	baseline and 6 months post enrollment
Number of Quit Attempts at 6 Weeks	Secondary outcomes include number of quit attempts at 6 weeks post enrollment.	6 weeks post enrollment
Number of Quit Attempts at 6 Months	Secondary outcomes include number of quit attempts at 6 months post enrollment.	6 months post enrollment
Readiness to Quit at 6 Weeks	Secondary outcomes include readiness to quit at 6 weeks post enrollment as measured by a readiness to quit scale. Scale name: The Contemplation Ladder Reference: Biener L., Abrams D.B. The Contemplation Ladder: Validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10:360-365. doi: 10.1037/0278-6133.10.5.360. What scale measures: the smoker's motivation to quit smoking. The Contemplation Ladder is a validated score that correlates with the likelihood of making a quit attempt and participation in activities associated with quit attempts. The Contemplation Ladder is a 1-item, 11-point scale of motivation to quit. The question asks: "Mark the number that shows how you feel about quitting. Minimum score: 0 = no thought of quitting Maximum score: 10= taking action to quit Lower scores indicate worse outcomes. Higher scores indicate better outcomes. There are no subscales and one score is chosen by the smoker.	6 weeks post enrollment
Readiness to Quit at 6 Months	Secondary outcomes include readiness to quit at 6 months post enrollment as measured by a readiness to quit scale. Scale name: The Contemplation Ladder Reference: Biener L., Abrams D.B. The Contemplation Ladder: Validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10:360-365. doi: 10.1037/0278-6133.10.5.360. What scale measures: the smoker's motivation to quit smoking. The Contemplation Ladder is a validated score that correlates with the likelihood of making a quit attempt and participation in activities associated with quit attempts. The Contemplation Ladder is a 1-item, 11-point scale of motivation to quit. The question asks: "Mark the number that shows how you feel about quitting. Minimum score: 0 = no thought of quitting Maximum score: 10= taking action to quit Lower scores indicate worse outcomes. Higher scores indicate better outcomes. There are no subscales and one score is chosen by the smoker.	6 months post enrollment
Use of Cessation Resources at 6 Weeks	Secondary outcomes include use of cessation resources at 6 weeks post enrollment.	6 weeks post enrollment
Use of Cessation Resources at 6 Months	Secondary outcomes include use of cessation resources at 6 months post enrollment.	6 months post enrollment

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: E. Melinda Mahabee-Gittens, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

General Publications

• 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, 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2016
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 21, 2015
• First Posted (Estimated): August 24, 2015

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: CINC 2015-1914; 1R01HD083354 (U.S. NIH Grant/Contract); R01ES027815 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO