Lung DiseasesNCT00217893
Environmental Tobacco Smoke Exposure Reduction in High-Risk Preteens
A study testing Counseling, Urine Cotinine Feedback and Contingent Incentives in people with Lung Diseases and Asthma, run by San Diego State University at 1 site in United States.
Trial summary
This study will determine the effect of combining counseling, urine cotinine feedback, and incentives in reducing environmental tobacco smoke (ETS) exposure and susceptibility to smoking among high-risk preteens. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Lung Diseases, Asthma
- What is being tested?
- Counseling, Urine Cotinine Feedback and Contingent Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Jan 2008
- 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Non-smoking preteen
- Resides in San Diego county
- Smoker lives in the household
- Exposed to an average of 2 cigarettes per day over the week prior to study entry OR urine cotinine greater than or equal to 2.0 ng/mL
Who cannot join
- Preteen who has smoked in the 30 days prior to study entry or who has smoked more than 10 cigarettes within lifetime
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92123
About this study
Official title: ETS Reduction in High-Risk Preteens: A Controlled Trial
This study will determine the effect of combining counseling, urine cotinine feedback, and incentives in reducing environmental tobacco smoke (ETS) exposure and susceptibility to smoking among high-risk preteens.
Read the detailed description
BACKGROUND:
Parent counseling reduced children's ETS exposure in previous studies. This study will determine if interventions directed to preteens alone can reduce ETS exposure. The original pilot study showed that counseling reduced preteen's ETS exposure. New analyses showed that counseling reduced exposure to preteens in the NIH asthma study. A third pilot study showed that counseling plus feedback and incentives reduced preteens' ETS exposure. Based on these results, the number of counseling sessions were decreased to 10, inclusion criteria were liberalized, and recruitment sources were added to assure feasibility.
DESIGN NARRATIVE:
This study will determine the effect of combining counseling, feedback, and incentives on reducing second hand smoke (SHS) exposure and susceptibility to smoking among high-risk preteens. Two hundred youth aged 8 to 13 years old, including African American, Latino, Anglo, and other racial/ethnic groups, will be recruited. Preteens must be nonsmokers who are exposed to ETS in their home. Youth will be recruited sequentially and assigned to usual education or a combination of counseling, cotinine feedback, and contingent incentives. Outcome measures will be obtained prior to intervention, and at Months 5, 9, and 12. Preteens in the intervention condition will receive eight in-home counseling sessions and seven phone counseling sessions over a 5-month period. Urine samples will be analyzed for cotinine using highly sensitive (detection limit .05 ng/ml) and reliable procedures as employed by CDC (ID-LC/MS/MS). The same measures will be used for cotinine feedback for preteens in the intervention condition. Repeated measures analyses of differential exposure to ETS will be employed. Mixed effect regression (REML) and generalized estimating equations (GEE) models will be used for outcome analyses. Exploratory analyses will address questions about the environmental and social determinants of tobacco use and ETS exposure based on the researcher's Behavioral Ecological Model.
Primary objectives include the following: 1) to determine whether counseling plus cotinine feedback and incentives reduces ETS exposure more than does usual tobacco control education (measured by self-report ETS exposure by preteen and parent, and preteen urine cotinine at Month 5); and 2) to determine whether the experimental condition results in differential maintenance in ETS exposure-reduction compared to usual tobacco control education during follow-up (measured by self-report ETS exposure by preteen and parent, and preteen urine cotinine at Months 9 and 12).
Secondary objectives include the following: 1) to explore whether there is a differential rate of cigarette experimentation between groups; to explore whether there is a differential rate of experimentation with alcohol/drugs among groups; 2) to explore the differential level of tobacco use "susceptibility" among experimental groups; 3) to explore the degree to which youth avoid ETS exposure from family members and friends; and 4) to explore the multiple social and possible genetic factors that are independent and in combined association with ETS exposure and change in exposure (measured by preteen and parent self-report at Months 5, 9, and 12).
- Conditions
- Lung Diseases, Asthma
- Being tested
- Counseling, Urine Cotinine Feedback, Contingent Incentives, Usual education program
- Medical subject headings
- Lung Diseases, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
One-on-one behavioral counseling with pre-teen child; 8 to 10 weekly or bi-weekly sessions; focus on identifying sources of exposure to ETS and means to avoid exposure; goal-setting, role-playing, monitoring progress, feedback includes reported info and urine cotinine level.
Urine Cotinine FeedbackBehavioural
Urine collected from child at each weekly/bi-weekly counseling session; cotinine level discussed at subsequent session.
Contingent IncentivesBehavioural
Child earns small prizes for on-task behavior in sessions, plus earns tokens redeemable for other prizes based on reduction in ETS exposure (reported and cotinine level).
Usual education programBehavioural
Participants will receive the usual education about ETS.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Combination of counseling, cotinine feedback, and contingent incentives. Receives: Behavioral: Counseling; Behavioral: Urine Cotinine Feedback; Behavioral: Contingent Incentives |
| 2 | Active comparator | Usual education program Receives: Behavioral: Usual education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
ETS exposure
Measured: Measured from baseline to 5 months
Maintenance in ETS exposure-reduction
Measured: Measured 5, 9, and 12 months post-baseline
Secondary outcomes (4)
Tobacco use experimentation
Measured: Measured from baseline through 5, 9, and 12 months
Experimentation with alcohol/drugs
Measured: Measured from baseline through 5, 9, and 12 months
Avoidance of ETS exposure from family members and friends
Measured: Measured from baseline through 5, 9, and 12 months
Multiple social and possible genetic factors that are independent and in combined association with ETS exposure and change in exposure
Measured: Measured from baseline through 5, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by San Diego State 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Melbourne Hovell, San Diego State University
- Investigators
- Melbourne F. Hovell, Study chair, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00217893
- Sponsor's protocol ID
- 293
- Other IDs
- R01HL066307
- Status last verified
- Oct 2013
- First submitted
- 19 Sep 2005
- Last updated
- 24 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ETS Reduction in High-Risk Preteens: A Controlled Trial
- ClinicalTrials.gov ID
- NCT00217893
- Acronym / sponsor ID
- 293
- Conditions
- Lung Diseases, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2003
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- 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.
This study will determine the effect of combining counseling, urine cotinine feedback, and incentives in reducing environmental tobacco smoke (ETS) exposure and susceptibility to smoking among high-risk preteens.
Detailed description
BACKGROUND:
Parent counseling reduced children's ETS exposure in previous studies. This study will determine if interventions directed to preteens alone can reduce ETS exposure. The original pilot study showed that counseling reduced preteen's ETS exposure. New analyses showed that counseling reduced exposure to preteens in the NIH asthma study. A third pilot study showed that counseling plus feedback and incentives reduced preteens' ETS exposure. Based on these results, the number of counseling sessions were decreased to 10, inclusion criteria were liberalized, and recruitment sources were added to assure feasibility.
DESIGN NARRATIVE:
This study will determine the effect of combining counseling, feedback, and incentives on reducing second hand smoke (SHS) exposure and susceptibility to smoking among high-risk preteens. Two hundred youth aged 8 to 13 years old, including African American, Latino, Anglo, and other racial/ethnic groups, will be recruited. Preteens must be nonsmokers who are exposed to ETS in their home. Youth will be recruited sequentially and assigned to usual education or a combination of counseling, cotinine feedback, and contingent incentives. Outcome measures will be obtained prior to intervention, and at Months 5, 9, and 12. Preteens in the intervention condition will receive eight in-home counseling sessions and seven phone counseling sessions over a 5-month period. Urine samples will be analyzed for cotinine using highly sensitive (detection limit .05 ng/ml) and reliable procedures as employed by CDC (ID-LC/MS/MS). The same measures will be used for cotinine feedback for preteens in the intervention condition. Repeated measures analyses of differential exposure to ETS will be employed. Mixed effect regression (REML) and generalized estimating equations (GEE) models will be used for outcome analyses. Exploratory analyses will address questions about the environmental and social determinants of tobacco use and ETS exposure based on the researcher's Behavioral Ecological Model.
Primary objectives include the following: 1) to determine whether counseling plus cotinine feedback and incentives reduces ETS exposure more than does usual tobacco control education (measured by self-report ETS exposure by preteen and parent, and preteen urine cotinine at Month 5); and 2) to determine whether the experimental condition results in differential maintenance in ETS exposure-reduction compared to usual tobacco control education during follow-up (measured by self-report ETS exposure by preteen and parent, and preteen urine cotinine at Months 9 and 12).
Secondary objectives include the following: 1) to explore whether there is a differential rate of cigarette experimentation between groups; to explore whether there is a differential rate of experimentation with alcohol/drugs among groups; 2) to explore the differential level of tobacco use "susceptibility" among experimental groups; 3) to explore the degree to which youth avoid ETS exposure from family members and friends; and 4) to explore the multiple social and possible genetic factors that are independent and in combined association with ETS exposure and change in exposure (measured by preteen and parent self-report at Months 5, 9, and 12).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Counseling, Behavioral: Urine Cotinine Feedback, Behavioral: Contingent IncentivesCombination of counseling, cotinine feedback, and contingent incentives. |
| 2 | Active comparator | Behavioral: Usual education programUsual education program |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Non-smoking preteen
- Resides in San Diego county
- Smoker lives in the household
- Exposed to an average of 2 cigarettes per day over the week prior to study entry OR urine cotinine greater than or equal to 2.0 ng/mL
Key exclusion criteria (1 listed)
- Preteen who has smoked in the 30 days prior to study entry or who has smoked more than 10 cigarettes within lifetime
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 |
|---|---|---|
| CounselingOne-on-one behavioral counseling with pre-teen child; 8 to 10 weekly or bi-weekly sessions; focus on identifying sources of exposure to ETS and means to avoid exposure; goal-setting, role-playing, monitoring progress, feedback includes reported info and urine cotinine level. | Behavioural | 1 |
| Urine Cotinine FeedbackUrine collected from child at each weekly/bi-weekly counseling session; cotinine level discussed at subsequent session. | Behavioural | 1 |
| Contingent IncentivesChild earns small prizes for on-task behavior in sessions, plus earns tokens redeemable for other prizes based on reduction in ETS exposure (reported and cotinine level). | Behavioural | 1 |
| Usual education programParticipants will receive the usual education about ETS. | Behavioural | 2 |
Primary outcome
ETS exposure
Time frame: Measured from baseline to 5 months
Maintenance in ETS exposure-reduction
Time frame: Measured 5, 9, and 12 months post-baseline
4 secondary outcomes
Tobacco use experimentation
Time frame: Measured from baseline through 5, 9, and 12 months
Experimentation with alcohol/drugs
Time frame: Measured from baseline through 5, 9, and 12 months
Avoidance of ETS exposure from family members and friends
Time frame: Measured from baseline through 5, 9, and 12 months
Multiple social and possible genetic factors that are independent and in combined association with ETS exposure and change in exposure
Time frame: Measured from baseline through 5, 9, and 12 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 24 Oct 2013.
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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.
Melbourne F. Hovell study chair
San Diego State 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 Counseling, Urine Cotinine Feedback and Contingent Incentives in people with Lung Diseases and Asthma, run by San Diego State 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 1 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 24 Oct 2013. 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?
ETS exposure (time frame: Measured from baseline to 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2013.