- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00810901
Intervention to Motivate Teens to be a Designated Organ Donor on Driver's License (Idecide)
June 23, 2015 updated by: University of Hawaii
Multimedia Intervention to Motivate Ethnic Teens to be Designated Donors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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 concrete 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/state identification card (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.
Study Type
Interventional
Enrollment (Actual)
429
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96822
- University of Hawaii School of Nursing and Dental Hygiene
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 15 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adolescent aged 14-19
- member of a school club, youth program or teen group
- read and speak English
- parent provides consent
Exclusion Criteria:
- plans to permanently move out of state
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Organ Donor
Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.
|
Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.
Other Names:
|
|
Active Comparator: Alcohol Prevention
Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol
|
Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Designated Organ Donor Status on Driver's License
Time Frame: 12 months
|
Number of students who reported not being donor at baseline but were donor at 12 months follow-up
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Talked to Parents About Choice to be Organ Donor on License at 12 Months
Time Frame: 12 months
|
Number of teens who talk had not talked to parents at baseline but reported they had talked to their parents about the choice to become an organ donor on their driver's license at 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cheryl Albright, PhD, MPH, University of Hawaii
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
December 17, 2008
First Submitted That Met QC Criteria
December 17, 2008
First Posted (Estimate)
December 18, 2008
Study Record Updates
Last Update Posted (Estimate)
June 25, 2015
Last Update Submitted That Met QC Criteria
June 23, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK079684
- R01DK079684 (U.S. NIH Grant/Contract)
- R01DK079684-03S1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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