Clinical trial NCT03099811: Financial Incentives to Reduce Pediatric Tobacco Smoke Exposures
Official title: Contingency Management for Controlling Secondhand Smoke Exposures Among Asthmatic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Incentives
Tobacco Smoking
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 147
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Secondhand smoke exposure (SHSe) is one of the most common and potentially modifiable environmental triggers for asthma. Financial incentivization may serve as an effective modality to reduce SHSe among pediatric asthmatics with potential down-stream benefits on improved asthma control and subsequent reduced healthcare utilization. This study plans on testing the feasibility and effectiveness of financial incentives to decrease SHSe, derived from primary caregivers and a member of their social network, of children with persistent asthma.

Detailed description: The impact of continued cigarette usage is profoundly felt not only upon the primary smoker, but also among children where SHSe is linked with asthma exacerbations. Children with caregivers who are active smokers are more likely to utilize acute healthcare resources and miss more days of school due to asthma symptoms. Issues of pediatric smoke exposure are notably higher among low-income populations. This particular group has a greater amount of financial strain that increases their desire to cease smoking but is among the least successful at accomplishing this task. Aggressive marketing campaigns by cigarette companies have specifically targeted the urban poor but similar techniques by public health officials, though on a much diminished scale, have yet to completely counter the hold that this addictive product has on members of lower socioeconomic status. One approach that has demonstrated efficacy in reducing smoking in resistant populations emphasizes financial incentives. Incentives may provide a substitute for the gratification derived from nicotine if they are properly structured. This proposal applies a contingency management schema among caregivers of pediatric asthmatics and a member of their caregiver's social network - both of whom are likely major contributors to the child's total secondhand smoke exposure. A pilot two-arm randomized-control trial will be employed over a 6-month time interval.The study population will consist of the primary caregiver and a selected member of their social network, both of who are known active smokers, and contemplating smoking cessation; both individuals spend time (either indoors or outdoors) with the asthmatic child. We will recruit 50 caregiver-child-social network triads among a population of children diagnosed with uncontrolled, persistent asthma and routinely exposed to high levels of SHSe. Caregivers and members of their social network who are both active smokers will be randomized to receive standard smoking cessation strategies (n=25 triads) with or without financial incentives (n=25 triads). SHSe will be measured directly using salivary cotinine levels from children and home air nicotine levels. Caregiver and social network member smoking behaviors will be measured by nicotine biomarkers; both test results will be the basis for incentive payments. Asthma control will be evaluated using validated questionnaires and review of the participant's electronic health record.

Eligibility criteria: Inclusion Criteria:

* Primary caregiver aged greater than 18 years who is an active smoker.
* Child aged 2-12 years of age who meets clinical criteria for persistent asthma and has nicotine biomarker levels consistent with secondhand smoke exposure
* Designated social network member who is an active smoker
* Residence in Baltimore City

Exclusion Criteria:

* Child has current diagnosis of another major pulmonary disease or other significant medical co-morbidity
* Use of electronic cigarettes (e-cigarettes) by the adult-enrolled participants

Primary outcomes:
measure: Pediatric secondhand smoke exposures
timeFrame: 6 months
Secondary outcomes:
measure: Nicotine biomarkers
timeFrame: 6 months
measure: Air nicotine
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mandeep S Jassal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jassal MS, Lewis-Land C, Thompson RE, Butz A. Randomised pilot trial of cash incentives for reducing paediatric asthmatic tobacco smoke exposures from maternal caregivers and members of their social network. Arch Dis Child. 2021 Apr;106(4):345-354. doi: 10.1136/archdischild-2019-318352. Epub 2020 Oct 1.