Environmental Tobacco Smoke Exposure Reduction in High-Risk Preteens
ETS Reduction in High-Risk Preteens: A Controlled Trial
2 other identifiers
interventional
203
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 19, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedOctober 24, 2013
October 1, 2013
4.9 years
September 19, 2005
October 22, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
ETS exposure
Measured from baseline to 5 months
Maintenance in ETS exposure-reduction
Measured 5, 9, and 12 months post-baseline
Secondary Outcomes (4)
Tobacco use experimentation
Measured from baseline through 5, 9, and 12 months
Experimentation with alcohol/drugs
Measured from baseline through 5, 9, and 12 months
Avoidance of ETS exposure from family members and friends
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 from baseline through 5, 9, and 12 months
Study Arms (2)
1
EXPERIMENTALCombination of counseling, cotinine feedback, and contingent incentives.
2
ACTIVE COMPARATORUsual education program
Interventions
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 collected from child at each weekly/bi-weekly counseling session; cotinine level discussed at subsequent session.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Preteen who has smoked in the 30 days prior to study entry or who has smoked more than 10 cigarettes within lifetime
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Diego State University
San Diego, California, 92123, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Melbourne F. Hovell
San Diego State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 19, 2005
First Posted
September 22, 2005
Study Start
February 1, 2003
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
October 24, 2013
Record last verified: 2013-10