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| Tracking Information | |||||
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| First Received Date ICMJE | April 28, 2003 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | May 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00059514 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Tobacco Use Among Arab American Youth | ||||
| Official Title ICMJE | Arab American Youth: Tobacco Use and Intervention | ||||
| Brief Summary | Michigan has the 10th highest smoking rate in the nation. Smoking rates are also very high in the Middle East and in Arab American families. The purpose of this study is to learn about tobacco use in Michigan Arab American youth ages 14 to 18. The study will evaluate why some young people start smoking and others do not. The study will also test an educational program designed to encourage young people to either quit tobacco use or to avoid it. |
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| Detailed Description | Cigarette smoking is the chief avoidable cause of death and disease in Michigan, the United States, and the world. In 1996, 25.9% of the Michigan adult population smoked cigarettes; Michigan has the 10th highest smoking rate in the nation. When the indirect costs of lost income due to smoking-related illnesses and premature death are added to the cost of medical care, tobacco use costs Michigan citizens more than $2.6 billion per year (Michigan Department of Community Health (MDCH), 1996). Contributing to tobacco use statistics in Michigan is a rapidly growing Arab American immigrant population. Studies have shown cigarette smoking rates in Middle-Eastern adolescents range from 33% to 58%. This study will examine cultural, personal, social, and environmental forces operating in Arab American youths at risk for habitual tobacco use. The study will also test the effects of a smoking cessation/prevention intervention on smoking behavior. The settings for this study are the Arab Community Center for Economic and Social Services (ACCESS) Teen Health Center, which services almost 2,500 youth visits each year, and local high schools with a significant population of Arab American youth. The majority of the people served by the clinic are poor, under-educated, live in extended families of 3 to 5 adults, are immigrants, and speak Arabic as a first language. A total of 4,000 adolescents over 14 years old will be asked to provide information on demographic and cultural variables, self-esteem, stress, family and peer tobacco use, intention to use tobacco, history of tobacco use, initial stage of change, and perceived health. Youths with the highest risk for tobacco use will be randomly assigned to either a Modified Project Toward No Tobacco Use (Project TNT) intervention or a wait list control group. Project TNT, the precursor to the Arab American-specific modified Project TNT, was designed to target the primary causes of tobacco use among adolescents and has been shown to be effective in diverse cultural groups. The modified Project TNT consists of weekly 40-minute sessions with a health educator over 4 weeks. Bilingual health educators will deliver the intervention in a small group (four to six adolescents) or classroom context. Follow-up data will be collected at 3, 6, and 12 months after the program is completed. Youth assigned to the wait list control group will participate in the modified Project TNT after the Month 6 follow-up data is collected from the first group. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Educational/Counseling/Training, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Tobacco Use Disorder | ||||
| Intervention ICMJE | Behavioral: Modified Project Toward No Tobacco Use | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 4000 | ||||
| Completion Date | April 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria
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| Gender | Both | ||||
| Ages | 14 Years to 18 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00059514 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 5R01HD37498-3 | ||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Verification Date | April 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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