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Completed

NCT Number: NCT02531594

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Eligible participants must:

  • 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.

Exclusion criteria

Caregivers will be excluded 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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 6 weeks post enrollment

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

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

    Time frame: 6months post enrollment

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

Secondary outcomes

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

    Time frame: baseline and 6 weeks post enrollment

    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.

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

    Time frame: baseline and 6 months post enrollment

    Secondary outcomes include number of cigarettes smoked at 6 months post enrollment as compared with baseline.

  3. Number of Quit Attempts at 6 Weeks

    Time frame: 6 weeks post enrollment

    Secondary outcomes include number of quit attempts at 6 weeks post enrollment.

  4. Number of Quit Attempts at 6 Months

    Time frame: 6 months post enrollment

    Secondary outcomes include number of quit attempts at 6 months post enrollment.

  5. Readiness to Quit at 6 Weeks

    Time frame: 6 weeks post enrollment

    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. Readiness to Quit at 6 Months

    Time frame: 6 months post enrollment

    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.

  7. Use of Cessation Resources at 6 Weeks

    Time frame: 6 weeks post enrollment

    Secondary outcomes include use of cessation resources at 6 weeks post enrollment.

  8. Use of Cessation Resources at 6 Months

    Time frame: 6 months post enrollment

    Secondary outcomes include use of cessation resources at 6 months post enrollment.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Environmental Health Sciences (NIEHS)

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Aug 24, 2015
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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