Alcohol Abstinence, Tissue and Organ Procurement
Conditions
Keywords
ethnic minority adolescents, designated organ donor
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.
Interventions
BEHAVIORALOrgan Donor
Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail.
BEHAVIORALAlcohol Prevention
Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Hawaii
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Designated Organ Donor Status on Driver's License | 12 months | Number of students who reported not being donor at baseline but were donor at 12 months follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Talked to Parents About Choice to be Organ Donor on License at 12 Months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail. | 253 |
| Alcohol Prevention Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol
Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol. | 176 |
| Total | 429 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 88 | 58 |
Baseline characteristics
| Characteristic | Organ Donor | Alcohol Prevention | Total |
|---|---|---|---|
| Age, Continuous | 15.8 years STANDARD_DEVIATION 1.2 | 16.1 years STANDARD_DEVIATION 1.3 | 15.9 years STANDARD_DEVIATION 1.25 |
| Designated organ donor on driver's license Not organ donor on license at baseline | 201 participants | 137 participants | 338 participants |
| Designated organ donor on driver's license Organ donor on license at baseline | 52 participants | 39 participants | 91 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants | 35 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 209 Participants | 130 Participants | 339 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 11 Participants | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 147 Participants | 95 Participants | 242 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 35 Participants | 16 Participants | 51 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 50 Participants | 46 Participants | 96 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 15 Participants | 36 Participants |
| Region of Enrollment United States | 253 participants | 176 participants | 429 participants |
| Sex: Female, Male Female | 126 Participants | 87 Participants | 213 Participants |
| Sex: Female, Male Male | 127 Participants | 89 Participants | 216 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 253 | 2 / 176 |
| serious Total, serious adverse events | 0 / 253 | 0 / 176 |
Outcome results
Primary
Designated Organ Donor Status on Driver's License
Number of students who reported not being donor at baseline but were donor at 12 months follow-up
Time frame: 12 months
Population: t-test
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alcohol Prevention | Designated Organ Donor Status on Driver's License | 67 participants |
| Organ Donor | Designated Organ Donor Status on Driver's License | 38 participants |
Secondary
Talked to Parents About Choice to be Organ Donor on License at 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
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alcohol Prevention | Talked to Parents About Choice to be Organ Donor on License at 12 Months | 80 participants |
| Organ Donor | Talked to Parents About Choice to be Organ Donor on License at 12 Months | 74 participants |