AsthmaNCT03099811
Financial Incentives to Reduce Pediatric Tobacco Smoke Exposures
A study testing Incentive plan and Smoking cessation in people with Asthma and Incentives, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Incentives, Tobacco Smoking
- What is being tested?
- Incentive plan and Smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contingency Management for Controlling Secondhand Smoke Exposures Among Asthmatic Children
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.
Read the 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.
- Conditions
- Asthma, Incentives, Tobacco Smoking
- Being tested
- Incentive plan, Smoking cessation
- Medical subject headings
- Asthma, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive planBehavioural
Also called Contingency management
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.
Smoking cessationBehavioural
Also called Tobacco 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Financial incentives + Smoking cessation program | Experimental | 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. Receives: Behavioral: Incentive plan; Behavioral: Smoking cessation |
| Intervention: Smoking cessation program | Other | Caregiver and a social network member will be enrolled in a state-sponsored smoking cessation program. Receives: Behavioral: Smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric secondhand smoke exposures
Monthly measurement of pediatric secondhand smoke exposures. Secondhand smoke exposures will be measured using salivary cotinine levels.
Measured: 6 months
Secondary outcomes (2)
Nicotine biomarkers
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.
Measured: 6 months
Air nicotine
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Jun 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mandeep S Jassal, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099811
- Sponsor's protocol ID
- IRB00064875
- Status last verified
- Nov 2018
- First submitted
- 17 Mar 2017
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33004310
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management for Controlling Secondhand Smoke Exposures Among Asthmatic Children
- ClinicalTrials.gov ID
- NCT03099811
- Acronym / sponsor ID
- IRB00064875
- Conditions
- Asthma, Incentives, Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Financial incentives + Smoking cessation program | Experimental | Behavioral: Incentive plan, Behavioral: Smoking cessationCaregiver 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. |
| Intervention: Smoking cessation program | Other | Behavioral: Smoking cessationCaregiver and a social network member will be enrolled in a state-sponsored smoking cessation program. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentive planAlso: Contingency managementThe 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. | Behavioural | Intervention: Financial incentives + Smoking cessation program |
| Smoking cessationAlso: Tobacco cessationParticipants 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. | Behavioural | Intervention: Financial incentives + Smoking cessation program, Intervention: Smoking cessation program |
Primary outcome
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.
2 secondary outcomes
Nicotine biomarkers
Time frame: 6 months
Air nicotine
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Derived from this study: PubMed 33004310Jassal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mandeep S Jassal, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive plan and Smoking cessation in people with Asthma and Incentives, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric secondhand smoke exposures (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03099811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.