NCT02531594

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

Completed NA Results posted Last updated 15 September 2023

What this trial tests

NA trial testing SBIRT in Smoking Cessation in 770 participants. Completed in 31 December 2022.

Timeline

6 April 2016

Primary endpoint
31 December 2020

31 December 2022

Quick facts

Lead sponsor	Children's Hospital Medical Center, Cincinnati
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	770
Start date	6 April 2016
Primary completion	31 December 2020
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

• SBIRT
• HHC

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Eligibility, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Self-reported Prolonged Abstinence at 6 Weeks Primary · 6 weeks post enrollment

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

Group	Value	95% CI
SBIRT	4.2
Healthy Habits Control	4.2

Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months Primary · 6months post enrollment

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

Group	Value	95% CI
SBIRT	12.9
Healthy Habits Control	8.3

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

Group	Value	95% CI
SBIRT	-2	-5 – 0
Healthy Habits Control	0	-4 – 0

Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Months Secondary · baseline and 6 months post enrollment

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

Group	Value	95% CI
SBIRT	-4	-9 – -1
Healthy Habits Control	-2	-5 – 0

Number of Quit Attempts at 6 Weeks Secondary · 6 weeks post enrollment

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

Group	Value	95% CI
SBIRT	2.69	± 5.0
Healthy Habits Control	2.22	± 2.5

Number of Quit Attempts at 6 Months Secondary · 6 months post enrollment

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

Group	Value	95% CI
SBIRT	3.82	± 6.4
Healthy Habits Control	2.3	± 3.2

Readiness to Quit at 6 Weeks Secondary · 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 La

Group	Value	95% CI
SBIRT	6.98	± 2.5
Healthy Habits Control	6.46	± 2.8

Readiness to Quit at 6 Months Secondary · 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 L

Group	Value	95% CI
SBIRT	7.03	± 2.6
Healthy Habits Control	6.77	± 2.8

Use of Cessation Resources at 6 Weeks Secondary · 6 weeks post enrollment

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

Group	Value	95% CI
SBIRT	53
Healthy Habits Control	0

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preliminary evidence that high levels of nicotine on children's hands may contribute to overall tobacco smoke exposure.
   Mahabee-Gittens EM, Merianos AL, Matt GE. · · 2018 · cited 42× · PMID 28360145 · DOI 10.1136/tobaccocontrol-2016-053602
2. Nicotine on Children's Hands: Limited Protection of Smoking Bans and Initial Clinical Findings.
   Mahabee-Gittens EM, Merianos AL, Hoh E, Quintana PJ, et al · · 2019 · cited 31× · PMID 30728727 · DOI 10.1177/1179173x18823493
3. Differential associations of hand nicotine and urinary cotinine with children's exposure to tobacco smoke and clinical outcomes.
   Mahabee-Gittens EM, Merianos AL, Jandarov RA, Quintana PJE, et al · · 2021 · cited 26× · PMID 34297932 · DOI 10.1016/j.envres.2021.111722
4. 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.
   Mahabee-Gittens EM, Ammerman RT, Khoury JC, Stone L, et al · · 2017 · cited 22× · PMID 28464887 · DOI 10.1186/s12889-017-4278-8
5. Contribution of thirdhand smoke to overall tobacco smoke exposure in pediatric patients: study protocol.
   Mahabee-Gittens EM, Matt GE, Hoh E, Quintana PJE, et al · · 2019 · cited 13× · PMID 31046729 · DOI 10.1186/s12889-019-6829-7
6. Hand nicotine as an independent marker of thirdhand smoke pollution in children's environments.
   Mahabee-Gittens EM, Merianos AL, Stone L, Wullenweber CA, et al · · 2022 · cited 12× · PMID 35952873 · DOI 10.1016/j.scitotenv.2022.157914
7. Comparison of Levels of Three Tobacco Smoke Exposure Biomarkers in Children of Smokers.
   Mahabee-Gittens EM, Matt GE, Ding L, Merianos AL. · · 2021 · cited 9× · PMID 34831559 · DOI 10.3390/ijerph182211803
8. Hand Nicotine and Cotinine In Children Exposed to Cigars: A Pilot Study.
   Mahabee-Gittens EM, Matt GE, Jandarov RJ, Merianos AL. · · 2021 · cited 7× · PMID 34423080 · DOI 10.18001/trs.7.3.2