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Environmental Tobacco Smoke Exposure Reduction in High-Risk Preteens

Primary Purpose

Lung Diseases, Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling
Urine Cotinine Feedback
Contingent Incentives
Usual education program
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Diseases

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Diego State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Combination of counseling, cotinine feedback, and contingent incentives.

Usual education program

Outcomes

Primary Outcome Measures

ETS exposure
Maintenance in ETS exposure-reduction

Secondary Outcome Measures

Tobacco use experimentation
Experimentation with alcohol/drugs
Avoidance of ETS exposure from family members and friends
Multiple social and possible genetic factors that are independent and in combined association with ETS exposure and change in exposure

Full Information

First Posted
September 19, 2005
Last Updated
October 22, 2013
Sponsor
San Diego State University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00217893
Brief Title
Environmental Tobacco Smoke Exposure Reduction in High-Risk Preteens
Official Title
ETS Reduction in High-Risk Preteens: A Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Asthma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Combination of counseling, cotinine feedback, and contingent incentives.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Usual education program
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Urine Cotinine Feedback
Intervention Description
Urine collected from child at each weekly/bi-weekly counseling session; cotinine level discussed at subsequent session.
Intervention Type
Behavioral
Intervention Name(s)
Contingent Incentives
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Usual education program
Intervention Description
Participants will receive the usual education about ETS.
Primary Outcome Measure Information:
Title
ETS exposure
Time Frame
Measured from baseline to 5 months
Title
Maintenance in ETS exposure-reduction
Time Frame
Measured 5, 9, and 12 months post-baseline
Secondary Outcome Measure Information:
Title
Tobacco use experimentation
Time Frame
Measured from baseline through 5, 9, and 12 months
Title
Experimentation with alcohol/drugs
Time Frame
Measured from baseline through 5, 9, and 12 months
Title
Avoidance of ETS exposure from family members and friends
Time Frame
Measured from baseline through 5, 9, and 12 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melbourne F. Hovell
Organizational Affiliation
San Diego State University
Official's Role
Study Chair
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

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Environmental Tobacco Smoke Exposure Reduction in High-Risk Preteens

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