Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention
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|ClinicalTrials.gov Identifier: NCT03013816|
Recruitment Status : Recruiting
First Posted : January 9, 2017
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Organ Donor Registration Organ Donation Education||Behavioral: Organ Donation Education: Testimonial Messaging Behavioral: Organ Donation Education: Informational Messaging Behavioral: Organ Donation Education: Blended Messaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Experimental: Testimonial Messaging
There are no explicit statistics or facts about transplantation or donation in this video intervention. It is designed to appeal to those with lower motivation to process factual arguments, focusing instead on emotional appeal and peers modeling the targeted behavior, thus allowing for peripheral processing of the donation message.
Behavioral: Organ Donation Education: Testimonial Messaging
The testimonial messaging video intervention will be shown
Experimental: Informational Messaging
This video intervention will mirror common educational campaigns and focus exclusively on factual arguments for organ donation, including the current supply-demand problem in transplantation, common reasons for/against donor designation, myths about donation, religious views of donation, the importance of communicating the donation decision to parents, and information about donor registries and how to register as a donor. This video will appeal to those with greater motivation to process factual arguments for donor designation. The video will be narrated by male and female adolescent peers. No personal testimonials will be displayed in this video.
Behavioral: Organ Donation Education: Informational Messaging
The informational messaging video intervention will be shown
Experimental: Blended Messaging
This video intervention will comprise edited segments from the Informational Messaging and Testimonial Messaging videos.
Behavioral: Organ Donation Education: Blended Messaging
The blended messaging video intervention will be shown
- Organ Donation Registration [ Time Frame: 6 months ]The primary outcome is the adolescent's donor designation (yes-no) at the time of obtaining their first driver's license at the Registry of Motor Vehicles (RMV) office. For most study participants, this decision will occur within 3-6 months of the intervention. We have an established relationship with the Information Technology group in the Massachusetts Department of Transportation. They are able to provide us with de-identified individual-level data on donor designation, age, sex, and census tract identification. Additionally, adolescents will be asked to self-report age, sex, race/ethnicity, and school achievement level ("Mostly…As, Bs, Cs, Ds/Fs").
- Organ Donation Knowledge and Attitudes [ Time Frame: 1 week ]Twenty one item questionnaires will be completed by adolescents in the driver's education classroom at pre-intervention, post-intervention and at 1 week follow-up.
- Parental Commitment [ Time Frame: 6 months ]To assess the commitment of parent/legal guardian to authorize donation consent for study participant, parents of enrolled students will be asked to complete a short questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013816
|Contact: Aaron Fleishmanfirstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator: James R Rodrigue, PhD|
|Principal Investigator:||James Rodrigue, PhD||Beth Israel Deaconess Medical Center|