Intervention to Motivate Teens to be a Designated Organ Donor on Driver's License

NCT ID: NCT00810901

Last Updated: 2015-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 429 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

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.

Conditions

Tissue and Organ Procurement; Alcohol Abstinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Organ Donor

Intervention Type: BEHAVIORAL

Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.

Alcohol Prevention

Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol

Group Type: ACTIVE_COMPARATOR

Alcohol Prevention

Intervention Type: BEHAVIORAL

Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.

Interventions

Organ Donor

Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.

Intervention Type: BEHAVIORAL

Alcohol Prevention

Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.

Intervention Type: BEHAVIORAL

Other Intervention Names

Idecide Project; Roll of the Dice

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheryl Albright, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii

Locations

University of Hawaii School of Nursing and Dental Hygiene

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

R01DK079684

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01DK079684-03S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK079684

Identifier Type: -

Identifier Source: org_study_id