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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00810901 |
This study will test the effectiveness of a multimedia campaign to educate ethnic minority teens about the choice to become a designated organ donor on their first driver's license.
Condition | Intervention | Phase |
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Organ Donor |
Behavioral: Multimedia educational campaign Behavioral: Prevent use of alcohol |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Multimedia Intervention to Motivate Ethnic Teens to be Designated Donors |
Estimated Enrollment: | 540 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Use DVD, text messaging, emails, websites, US Mail, and telephone calls to educate teens about the choice to become an organ donor on their driver's license application.
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Behavioral: Multimedia educational campaign
Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.
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2: Active Comparator
Education about the laws that prohibit underage minors purchasing and consuming alcohol
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Behavioral: Prevent use of alcohol
Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.
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Less than a fourth of ethnic minority teens in the U.S. are a designated donor (DD) on their state-issued driver's license. Asian-American/Pacific Islander (AA/PI) adolescents in Hawaii are even less likely to be a DD or to have talked to their family about becoming an organ donor. Health education interventions for adolescents have demonstrated improvements in knowledge and intentions to be an organ donor; but, AA/PI teens are underrepresented in such studies. Nevertheless, whether changes in knowledge or intentions result in more organ donors is unclear, since previous studies have not included a concete behavioral outcome such as the teen becoming a donor on their driver's license. This application will test, via a randomized clinical trial, the efficacy of an Interactive Multimedia Intervention (IMI) to increase the number of AA/PI adolescents who are a DD on their state issued driver's license, identification card, or organ donor card/donor registry. Teen groups will be recruited from the community (churches and high schools, n = 40 groups, 530 teens) and randomly assigned to either the intervention or a comparison condition on prevention of underage drinking of alcohol. The theoretically-derived intervention will include culturally sensitive messages and information about being a designated donor that will be delivered via a DVD, Email, text/instant messaging, and websites. The comparison condition includes materials (DVD) previously shown to increase awareness about laws restricting access to alcohol by teens. The primary outcome is objectively validated donor status on a teens' driver's license/ID or donor card after 12 months of intervention. A secondary outcome is the reported rate of family discussions about organ donation and knowledge/intentions about donation. We hypothesize the youth groups assigned to the intervention will have higher rates for family discussions and DD status, compared to groups in the comparison condition. We will also test whether psychosocial and cultural factors act as mediators of any change in teens' knowledge, attitudes & stages of change to become a DD. After the randomized trial we will disseminate the intervention to Organ Procurement Organizations in Hawaii and other states, and track diffusion outcomes over a year. If IMI methods can increase the number of minority teens who become a DD on their driver's license by 10% this would translate to 500,000 more teenage designated donors in the U.S.
Ages Eligible for Study: | 14 Years to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cheryl Albright, PhD, MPH | 808 441 8189 | calbright@crch.hawaii.edu |
Contact: May Rose Dela Cruz, BA | 8084413485 | MRIsnec@crch.hawaii.edu |
United States, Hawaii | |
Cancer Research Center of Hawaii | Recruiting |
Honolulu, Hawaii, United States, 96822 | |
Contact: Sandy French 808-564-5978 sandy@crch.hawaii.edu | |
Contact: May Rose Dela Cruz |
Principal Investigator: | Cheryl Albright, PhD, MPH | University of Hawaii Cancer Research Center |
Responsible Party: | Cancer Research Center of Hawaii; University of Hawaii ( Cheryl L Albright,PhD, MPH; Associate Professor ) |
Study ID Numbers: | DK079684, 5R01Dk079684 |
Study First Received: | December 17, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00810901 |
Health Authority: | United States: Federal Government |
ethnic minority adolescents organ donor |
Ethanol |