Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Environmental Tobacco Smoke Exposure Reduction in High-Risk Preteens
This study is ongoing, but not recruiting participants.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00217893
  Purpose

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.


Condition Intervention
Lung Diseases
Asthma
Behavioral: Counseling
Behavioral: Urine Cotinine Feedback
Behavioral: Contingent Incentives
Behavioral: Usual education program

MedlinePlus related topics: Asthma Smoking Smoking and Youth Urine and Urination
Drug Information available for: Cotinine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: ETS Reduction in High-Risk Preteens: A Controlled Trial

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • ETS exposure [ Time Frame: Measured from baseline to 5 months ] [ Designated as safety issue: No ]
  • Maintenance in ETS exposure-reduction [ Time Frame: Measured 5, 9, and 12 months post-baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tobacco use experimentation [ Time Frame: Measured from baseline through 5, 9, and 12 months ] [ Designated as safety issue: No ]
  • Experimentation with alcohol/drugs [ Time Frame: Measured from baseline through 5, 9, and 12 months ] [ Designated as safety issue: No ]
  • Avoidance of ETS exposure from family members and friends [ Time Frame: Measured from baseline through 5, 9, and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 203
Study Start Date: February 2003
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Combination of counseling, cotinine feedback, and contingent incentives.
Behavioral: Counseling
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.
Behavioral: Urine Cotinine Feedback
Urine collected from child at each weekly/bi-weekly counseling session; cotinine level discussed at subsequent session.
Behavioral: Contingent Incentives
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).
2: Active Comparator
Usual education program
Behavioral: Usual education program
Participants will receive the usual education about ETS.

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).

  Eligibility

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Preteen who has smoked in the 30 days prior to study entry or who has smoked more than 10 cigarettes within lifetime
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00217893

Locations
United States, California
San Diego State University
San Diego, California, United States, 92123
Sponsors and Collaborators
Investigators
Study Chair: Melbourne F. Hovell San Diego State University
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: San Diego State University Research Foundation ( Melbourne F. Hovell, Ph.D., M.P.H. / Professor, GSPH )
Study ID Numbers: 293, R01 HL066307
Study First Received: September 19, 2005
Last Updated: December 28, 2007
ClinicalTrials.gov Identifier: NCT00217893  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Smoking
Respiratory Tract Diseases
Lung Diseases
Asthma

ClinicalTrials.gov processed this record on January 14, 2009