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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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).

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 groups in NCT00217893
Study groupRoleWhat they receive
1ExperimentalCombination of counseling, cotinine feedback, and contingent incentives.
Receives: Behavioral: Counseling; Behavioral: Urine Cotinine Feedback; Behavioral: Contingent Incentives
2Active comparatorUsual education program
Receives: Behavioral: Usual education program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ETS exposure

    Measured: Measured from baseline to 5 months

  2. Maintenance in ETS exposure-reduction

    Measured: Measured 5, 9, and 12 months post-baseline

Secondary outcomes (4)
  1. Tobacco use experimentation

    Measured: Measured from baseline through 5, 9, and 12 months

  2. Experimentation with alcohol/drugs

    Measured: Measured from baseline through 5, 9, and 12 months

  3. Avoidance of ETS exposure from family members and friends

    Measured: Measured from baseline through 5, 9, and 12 months

  4. 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.

  1. First posted22 Sep 2005 (estimated)
  2. Study startFeb 2003
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

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)
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

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.

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