An interventional study of MADD Materials and Surgeon General Materials in Underage Drinking, Driving Under the Influence and Drinking, Teen, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 15 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-29.
Sponsored by Penn State University · Not applicable, Interventional, and Prevention
Project MADD was designed to attempt to curb the alarming trends related to drunk driving and to move the field forward by testing a brief parent-intervention's ability to change adolescents' drinking, impaired driving, and riding with impaired driver behaviors. The aim of this project is to provide an easy-to-implement and low-cost alternative parent-based intervention that can be widely disseminated to address this important public health problem.
Drunk driving is a major public health problem. The National Highway Traffic Safety Administration reported nearly 10,000 people died in alcohol-related crashes in the U.S. in 2014. The problem is further magnified when one considers that each year over 1.3 million drivers in the U.S. are arrested for alcohol-impaired driving. As alarming as these statistics are they pale by comparison to estimates indicating that they only represent 1% of the 121 million self-reported episodes of alcohol-impaired driving among U.S. drivers each year. The proposed research will attempt to curb these alarming trends and move the field forward by conducting a randomized controlled trial testing a brief parent intervention's ability to change adolescents' drinking, impaired driving, and riding with impaired driver behaviors. Prior brief parent-based interventions fro this lab have provided sufficient preliminary evidence of participation, communication, and efficacy for changing under-age drinking to warrant a large-scale comprehensive study. The study will use an extremely rigorous design that meets the Society for Prevention Research Criteria for Efficacy as described in Flay et al., a nationally representative sample assessed at 3-waves (baseline, 6 mo. and 12 mo.) to examine generalizability and sustained effects, and an oversampled Hispanic/Latino subgroup to examine the parent-intervention's potential to reduce a health disparity in an underserved population. The aims are as follows: Aim 1: Evaluate the efficacy of the parent intervention (short and long term); Aim 2: Examine mediators of the PBI that directly influence drinking, impaired driving, and riding with impaired driver behaviors; and Aim 3: Identify moderators to help inform future tailoring and improvement in intervention effectiveness. To the extent that the research is successful, it will provide an easy to implement and low cost alternative that can be widely disseminated to address this important public health problem.
Exclusion Criteria:
Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
Behavioral: MADD Materials
Information published by the Surgeon General about teens and drinking
Behavioral: Surgeon General Materials
TAU
Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens
Information published by the Surgeon General about teens and drinking
Typical Weekend Drinking (DDQ)
Typical weekend drinking was assessed using the Daily Drinking Questionnaire (DDQ; Collins et al., 1985), which asked teens to indicate the number of drinks they consumed on a typical Friday and Saturday during the past 6 months. These two items were summed to create the number of typical weekend drinks. Higher scores indicate the teen consumed a higher number of drinks on a typical weekend.
Time frame: Baseline, 6 month follow-up, and 12 month follow-up
Declining to Ride With Impaired Drivers
Declining riding with impaired drivers was assessed with two items adapted from Hultgren et al (2018). Teens were asked to indicate the number of times they declined a ride from a driver that consumed alcohol and the number of times they declined a ride from a driver that consumed any drug other than alcohol (e.g., marijuana, opioids) in the past 6 months. Responses were summed to indicate the number of times they declined rides from impaired drivers in the past 6 months. Higher scores indicate the participant declined more rides from impaired drivers.
Time frame: T4 (12-months post-baseline)
Willingness to Ride in a Car With an Impaired Driver
Willingness to ride in a car with an impaired driver was assessed with two items adapted from Hultgren et al. (2018). Teens responded using a 7-point scale that ranged from (0) Strongly disagree to (6) Strongly agree on their level of agreement to the following statements, "I am willing to be a passenger in a vehicle when the driver has consumed alcohol." and "I am willing to be a passenger in a vehicle when the driver has consumed any drug other than alcohol (e.g., marijuana, ecstasy, opioids).". Responses were averaged to create a mean score. Higher scores indicate the participant is more willing to be a passenger in a car with an impaired driver.
Time frame: Baseline, 6 month follow-up, and 12 month follow-up
Parent-teen dyads were recruited from a nationally representative predetermined Web panel (KnowledgePanel, KP) maintained by the consumer company Ipsos. KP members were randomly selected through probability-based sampling of addresses from the U.S. Postal Services' Delivery Sequence File which covers approximately 97% of U.S. households. Only individuals who were sampled through these probability-based techniques were eligible to participate.
| Milestone | MADD Materials | Surgeon General Materials | Active Control |
|---|---|---|---|
| Started | 393 | 393 | 390 |
| T2 (30 -days post-baseline) | 331 | 328 | 342 |
| T3 (6-months post-baseline) | 315 | 318 | 319 |
| T4 (12-months post-baseline) | 296 | 305 | 305 |
| Completed | 296 | 305 | 305 |
| Not completed | 97 | 88 | 85 |
Typical weekend drinking was assessed using the Daily Drinking Questionnaire (DDQ; Collins et al., 1985), which asked teens to indicate the number of drinks they consumed on a typical Friday and Saturday during the past 6 months. These two items were summed to create the number of typical weekend drinks. Higher scores indicate the teen consumed a higher number of drinks on a typical weekend.
| units on a scale | MADD Materials | Surgeon General Materials | Active Control |
|---|---|---|---|
| Typical Weekend Drinking (DDQ) | 0.53 ± 1.56 | 0.53 ± 1.57 | 0.38 ± 1.23 |
Declining riding with impaired drivers was assessed with two items adapted from Hultgren et al (2018). Teens were asked to indicate the number of times they declined a ride from a driver that consumed alcohol and the number of times they declined a ride from a driver that consumed any drug other than alcohol (e.g., marijuana, opioids) in the past 6 months. Responses were summed to indicate the number of times they declined rides from impaired drivers in the past 6 months. Higher scores indicate the participant declined more rides from impaired drivers.
| units on a scale | MADD Materials | Surgeon General Materials | Active Control |
|---|---|---|---|
| Declining to Ride With Impaired Drivers | 0.61 ± 1.56 | 0.56 ± 1.38 | 0.31 ± 0.99 |
Willingness to ride in a car with an impaired driver was assessed with two items adapted from Hultgren et al. (2018). Teens responded using a 7-point scale that ranged from (0) Strongly disagree to (6) Strongly agree on their level of agreement to the following statements, "I am willing to be a passenger in a vehicle when the driver has consumed alcohol." and "I am willing to be a passenger in a vehicle when the driver has consumed any drug other than alcohol (e.g., marijuana, ecstasy, opioids).". Responses were averaged to create a mean score. Higher scores indicate the participant is more willing to be a passenger in a car with an impaired driver.
| units on a scale | MADD Materials | Surgeon General Materials | Active Control |
|---|---|---|---|
| Willingness to Ride in a Car With an Impaired Driver | 1.22 ± 0.03 | 1.22 ± 0.03 | 1.22 ± 0.03 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MADD Materials | 0/393 (0%) | 0/393 (0%) | 0/393 (0%) |
| Surgeon General Materials | 0/393 (0%) | 0/393 (0%) | 0/393 (0%) |
| Active Control | 0/390 (0%) | 0/390 (0%) | 0/390 (0%) |
| Age, Categorical(Participants) | MADD Materials | Surgeon General Materials | Active Control | Total |
|---|---|---|---|---|
| Teen Participants — <=18 years | 393 | 393 | 390 | 1176 |
| Teen Participants — Between 18 and 65 years | 0 | 0 | 0 | 0 |
| Teen Participants — >=65 years | 0 | 0 | 0 | 0 |
| Parent Participants — <=18 years | 0 | 0 | 0 | 0 |
| Parent Participants — Between 18 and 65 years | 385 | 387 | 382 | 1154 |
| Parent Participants — >=65 years | 8 | 6 | 8 | 22 |
| Age, Continuous(years) | MADD Materials | Surgeon General Materials | Active Control | Total |
|---|---|---|---|---|
| Teen Participants | 16.29 ± 1.09 | 16.37 ± 1.11 | 16.33 ± 1.09 | 16.33 ± 1.09 |
| Parent Participants | 46.58 ± 7.44 | 46.90 ± 7.76 | 46.77 ± 7.65 | 46.75 ± 7.61 |
| Sex: Female, Male(Participants) | MADD Materials | Surgeon General Materials | Active Control | Total |
|---|---|---|---|---|
| Teen Participants — Female | 179 | 197 | 203 | 579 |
| Teen Participants — Male | 214 | 196 | 187 | 597 |
| Parent Participants — Female | 223 | 213 | 204 | 640 |
| Parent Participants — Male | 170 | 180 | 186 | 536 |
| Ethnicity (NIH/OMB)(Participants) | MADD Materials | Surgeon General Materials | Active Control | Total |
|---|---|---|---|---|
| Teen Participants — Hispanic or Latino | 115 | 103 | 98 | 316 |
| Teen Participants — Not Hispanic or Latino | 278 | 290 | 292 | 860 |
| Teen Participants — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Parent Participants — Hispanic or Latino | 106 | 97 | 90 | 293 |
| Parent Participants — Not Hispanic or Latino | 287 | 296 | 300 | 883 |
| Parent Participants — Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | MADD Materials | Surgeon General Materials | Active Control | Total |
|---|---|---|---|---|
| Teen Participants — American Indian or Alaska Native | 6 | 0 | 2 | 8 |
| Teen Participants — Asian | 15 | 12 | 13 | 40 |
| Teen Participants — Native Hawaiian or Other Pacific Islander | 1 | 1 | 1 | 3 |
| Teen Participants — Black or African American | 32 | 35 | 33 | 100 |
| Teen Participants — White | 288 | 305 | 300 | 893 |
| Teen Participants — More than one race | 31 | 23 | 30 | 84 |
| Teen Participants — Unknown or Not Reported | 20 | 17 | 11 | 48 |
| Parent Participants — American Indian or Alaska Native | 5 | 2 | 7 | 14 |
| Parent Participants — Asian | 13 | 9 | 12 | 34 |
| Parent Participants — Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 | 2 |
| Parent Participants — Black or African American | 32 | 31 | 39 | 102 |
| Parent Participants — White | 302 | 313 | 305 | 920 |
| Parent Participants — More than one race | 19 | 18 | 11 | 48 |
| Parent Participants — Unknown or Not Reported | 21 | 20 | 15 | 56 |
| Teen Typical Weekly Drinking (DDQ)(units on a scale) | MADD Materials | Surgeon General Materials | Active Control | Total |
|---|---|---|---|---|
| Mean | 0.23 ± 0.97 | 0.20 ± 0.85 | 0.23 ± 1.01 | 0.22 ± 0.94 |
| Teen Riding with Impaired Drivers Measures(units on a scale) | MADD Materials | Surgeon General Materials | Active Control | Total |
|---|---|---|---|---|
| Impaired driving | 0.16 ± 0.87 | 0.10 ± 0.68 | 0.08 ± 0.55 | 0.11 ± 0.71 |
| Declining to ride with impaired driver | 0.51 ± 1.33 | 0.44 ± 1.32 | 0.37 ± 1.17 | 0.44 ± 1.28 |
| Passenger in car with impaired driver | 0.57 ± 2.0 | 0.52 ± 1.82 | 0.46 ± 1.72 | 0.52 ± 1.85 |
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