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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA025301 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MADD Materials | Experimental | Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens |
|
| Surgeon General Materials | Experimental | Information published by the Surgeon General about teens and drinking |
|
| Control | No Intervention | TAU |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MADD Materials | Behavioral | Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | T4 (12-months post-baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Turrisi, Ph.D. | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State University | University Park | Pennsylvania | 16802 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | MADD Materials | Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens MADD Materials: Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens |
| FG001 | Surgeon General Materials | Information published by the Surgeon General about teens and drinking Surgeon General Materials: Information published by the Surgeon General about teens and drinking |
| FG002 | Active Control | Received HPV vaccine info |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MADD Materials | Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens MADD Materials: Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants included in analyses from T4 (12-month post-baseline assessment). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 month follow-up, and 12 month follow-up |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MADD Materials | Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens MADD Materials: Handbook developed by MADD and the PI to guide parents in discussing underage drinking, behaviors, and consequences with their teens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rob Turrisi | The Pennsylvania State University | 814-865-7808 | rturrisi@psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2023 | Jun 9, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000066608 | Underage Drinking |
| D000066448 | Driving Under the Influence |
| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| D001519 | Behavior |
| D000428 | Alcohol Drinking |
| D004327 | Drinking Behavior |
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1 group receives the MADD parent intervention; the second group receives parent materials from the Surgeon General; and the third group is TAU
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| Surgeon General Materials | Behavioral | Information published by the Surgeon General about teens and drinking |
|
| Baseline, 6 month follow-up, and 12 month follow-up |
| Surgeon General Materials |
Information published by the Surgeon General about teens and drinking Surgeon General Materials: Information published by the Surgeon General about teens and drinking |
| BG002 | Active Control | Received HPV vaccine info |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Teen Typical Weekly Drinking (DDQ) | Typical weekend drinking was assessed using the Daily Drinking Questionnaire (DDQ)[19], 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. | Mean | Standard Deviation | units on a scale |
|
| Teen Riding with Impaired Drivers Measures | Impaired driving, declining to ride, and being a passenger in a car were assessed with 6 items (2 items for each sub-scale) adapted from Hultgren et al., 2018. Teens were asked to indicate the number of times they drove, declined a ride, or were a passenger with a drinking driver or driver who consumed drugs in the past 6 months. Responses were summed to indicate the number of times this occurred. Higher scores indicate the participant drove drunk (worse outcome), declined a ride (positive outcome), or were a passenger (worse outcome) more times. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Surgeon General Materials | Information published by the Surgeon General about teens and drinking Surgeon General Materials: Information published by the Surgeon General about teens and drinking |
| OG002 | Active Control | Received HPV vaccine info |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | T4 (12-months post-baseline) |
|
|
|
|
| Secondary | 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. | Participants included in analyses from T3 (6-months post-baseline). These analyses examine participants willingness to ride in a car with an impaired driver. | Posted | Mean | Standard Error | units on a scale | Baseline, 6 month follow-up, and 12 month follow-up |
|
|
|
|
| 0 |
| 393 |
| 0 |
| 393 |
| 0 |
| 393 |
| EG001 | Surgeon General Materials | Information published by the Surgeon General about teens and drinking Surgeon General Materials: Information published by the Surgeon General about teens and drinking | 0 | 393 | 0 | 393 | 0 | 393 |
| EG002 | Active Control | Received HPV vaccine info | 0 | 390 | 0 | 390 | 0 | 390 |
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| D000066479 |
| Criminal Behavior |
| D003617 | Dangerous Behavior |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|