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Financial Incentives to Reduce Pediatric Tobacco Smoke Exposures

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ClinicalTrials.gov Identifier: NCT03099811
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE March 17, 2017
First Posted Date  ICMJE April 4, 2017
Last Update Posted Date November 20, 2018
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
Pediatric secondhand smoke exposures [ Time Frame: 6 months ]
Monthly measurement of pediatric secondhand smoke exposures. Secondhand smoke exposures will be measured using salivary cotinine levels.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • Nicotine biomarkers [ Time Frame: 6 months ]
    Monthly measurements of nicotine biomarkers to objectively assess tobacco usage. This will serve as the trigger for monthly financial incentives for those allocated to the intervention group.
  • Air nicotine [ Time Frame: 6 months ]
    Home air nicotine levels will be measured to assess if tobacco-derived indoor air pollutant levels will decline with the intervention. Air nicotine levels will be acquired through passive air samplers and measured using gas chromatography.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Financial Incentives to Reduce Pediatric Tobacco Smoke Exposures
Official Title  ICMJE Contingency Management for Controlling Secondhand Smoke Exposures Among Asthmatic Children
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Asthma
  • Incentives
  • Tobacco Smoking
Intervention  ICMJE
  • Behavioral: Incentive plan
    The caregiver and designated social network member can each receive monthly financial incentives over the 6 month time interval. Additional monthly incentives will be received at 3- and 6-months if the participant's previous two monthly biomarker levels were below the lower-limit cutoff.
    Other Name: Contingency management
  • Behavioral: Smoking cessation
    Participants who wish to quit smoking will be referred upon study recruitment to the smoking cessation program that is provided at no-cost by the Maryland Department of Health and Mental Hygiene (DMMH). The DMMH provides standard counseling and nicotine replacement pharmacotherapies for clients and is offered online or at six health centers throughout Baltimore City.
    Other Name: Tobacco cessation
Study Arms  ICMJE
  • Experimental: Intervention: Financial incentives + Smoking cessation program
    Caregiver and a social network member will receive financial incentives, in additional to enrollment in a state-sponsored smoking cessation program, based on nicotine biomarker measurements.
    Interventions:
    • Behavioral: Incentive plan
    • Behavioral: Smoking cessation
  • Intervention: Smoking cessation program
    Caregiver and a social network member will be enrolled in a state-sponsored smoking cessation program.
    Intervention: Behavioral: Smoking cessation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2018)
147
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2017)
150
Actual Study Completion Date  ICMJE November 1, 2018
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03099811
Other Study ID Numbers  ICMJE IRB00064875
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mandeep S Jassal, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP