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| ID | Type | Description | Link |
|---|---|---|---|
| 3U01DA040219-04S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This research will adapt an evidence based intervention for alcohol and other drugs and evaluate its efficacy on Prescription Stimulant Medication (PSM) misuse in a web-based format for use with college students who have misused PSMs.
This project proposes to evaluate the efficacy of Screening and Brief Interventions (SBIs) for reducing college students' PSM misuse through two different routes of screening and intervention across 9 colleges and universities spanning the United States. The research will consist of studies designed to 1) conduct focus groups to refine feedback materials (Study 1); 2) Conduct screening through the Registrar's student lists and implement a randomized controlled trial (RCT) of a web-based PSM intervention at all sites (Study 2); and 3) Evaluate the impact of the COVID-19 pandemic using the Study 2 sample on non-medical use of prescription stimulants, prescription opiates, alcohol use, marijuana use, and other substances during the COVID-19 pandemic, and understand motives, access, mental health impacts, and college student and young adult experiences during this unprecedented 12 months.
Study 1 consists of conducting up to 5 focus groups of 8-12 people to elicit feedback regarding the Personalized Feedback Tool and make refinements prior to carrying out Study 2.
In Study 2, students from 9 college campuses are screened for past year PSM misuse. Those meeting study criteria are invited to complete a web-based baseline survey and are randomized to either receive the web-based personalized feedback intervention (PFI) or to assessment only control. Participants complete follow-up assessments at 6 and 12 months post-baseline to evaluate intervention efficacy. The investigators hypothesize that participants who receive the PFI will reduce PSM misuse assessed at 6 and 12 month follow-ups. The investigators further expect reductions in perceived benefits of PSM and perceived descriptive norms for PSM, and increases in use of alternative behaviors to support academic success, and expect these changes will mediate impacts on PSM use at follow-ups. Secondary effects of the intervention on alcohol and marijuana use are also anticipated, and these reductions are expected to partially mediate PSM outcomes. Finally, PSM motives and demographics as potential moderators of intervention efficacy will also be explored.
Lastly, in February of 2021, we received approval to modify the aims for Study 3 to evaluate the impact of the COVID-19 pandemic using the Study 2 sample. In an already consented, recruited, and well-characterized sample of high-risk young adults reporting poly-substance use (Study 2 participants, n=843), Study 3 aimed to describe changes in non-medical use of prescription stimulants, prescription opiates, alcohol use, marijuana use, and other substances during the COVID-19 pandemic, and understand motives, access, mental health impacts, and college student and young adult experiences during this unprecedented 12 months. Specifically, we intend to evaluate changes pre- and post-pandemic in non-medical use of PSM, non-medical use of prescription opioid medications (POM), alcohol use, and marijuana use, as well as mood utilizing Study 2 baseline and follow-up data, controlling for intervention condition and time since last assessment. We also will evaluate student status and living arrangement as moderators. The investigators hypothesize: (1) Young adults will report less PSM and less POM during the pandemic compared to pre-pandemic assessments, in part due to reduced ease of access and a change in motives for use; (2) Given previous findings that academic motives were 8 of the 9 most frequently endorsed reasons for PSM, and given perceptions that a move to virtual learning has been less academically challenging, we hypothesize that academic motives for PSM will decrease significantly during the pandemic compared to pre-pandemic; (3) Those no longer in school will report less PSM and less POM during the pandemic compared to pre-pandemic. (4) Those living at home will have decreased alcohol and marijuana use compared to pre-pandemic. Among those reporting current student status at the time of the new survey, we will be able to evaluate changes in motives for use, access, and academic pressure from baseline to present.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-Based PFI | Experimental | Participants randomized to the web-based PFI in Study 2 receive a 5 component Personalized Feedback Tool. The first component is presented immediately after the baseline survey and a link to each of the remaining 4 components is sent to participants spaced 1 to 2 weeks apart. The PFI components cover: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol. Each component is comprised of personalized feedback presented in text and graphic format, and each component includes links to tips for making changes if and when the participant is contemplating or ready to commit to change. These tips include general relapse prevention strategies, as well as information about the importance of regular class attendance, study habits, and sleep habits for academic success. General educational tips/strategies for time management, as well as tips for initiating behavior change are also included. Each component takes approximately 5-10 minutes to review. |
|
| Assessment Only | Other | The Assessment Only group receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6-month follow-up, and 12-month follow-up in Study 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based PFI | Behavioral | A web-based 5 component Personalized Feedback Tool covering content on: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Past 6 Month Non-Medical Use of Prescription Stimulant Medication Frequency | Assesses frequency of non-medical use of prescription stimulant medications. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months |
| Change in Past 6 Month Medical Misuse of Prescription Stimulant Medication | Assesses past 6 month medical misuse of prescription stimulant medication. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months |
| Change in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool) | Assesses problematic use of tobacco, alcohol, prescription, and illicit drugs over the past year and 3 months. Response options included: 0= Never, 1= Less than Monthly, 2= Monthly, 3= Weekly, 4= Daily or Almost Daily. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months |
| Change in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants Only | Measures past 3 month non-medical use of prescription stimulants and associated negative consequences. Items were summed to create a scale summary score where higher values indicated more problematic use in the past 3 months (min=0, max=40). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Quantity of Alcohol Consumed in Past Month | Assesses quantity in standard drinks of peak drinking episode of alcohol consumption over the past month. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Past 6 Month Relapse Prevention/Protective Behaviors Scale | Measures the use of relapse prevention strategies and protective behaviors related to stimulant medication misuse. A score of "0" indicates that a given strategy did not occur and a score of "1" indicates that it did occur. Items were summed to create a scale summary score of overall number of unique relapse prevention/protective behavior strategies that occurred in the past 6 months (min=0, max=28). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). |
Study 1 Inclusion Criteria:
Study 1 Exclusion Criteria:
Study 2 Inclusion Criteria:
Study 2 Exclusion Criteria:
Study 3 Inclusion Criteria:
Study 3 Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Web-Based PFI | Participants randomized to the web-based PFI in Study 2 receive a 5 component Personalized Feedback Tool. The first component is presented immediately after the baseline survey and a link to each of the remaining 4 components is sent to participants spaced 1 to 2 weeks apart. The PFI components cover: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol. Each component is comprised of personalized feedback presented in text and graphic format, and each component includes links to tips for making changes if and when the participant is contemplating or ready to commit to change. These tips include general relapse prevention strategies, as well as information about the importance of regular class attendance, study habits, and sleep habits for academic success. General educational tips/strategies for time management, as well as tips for initiating behavior change are also included. Each component takes approximately 5-10 minutes to review. Web-based PFI: A web-based 5 component Personalized Feedback Tool covering content on: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol. |
| FG001 | Assessment Only | The Assessment Only group receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6-month follow-up, and 12-month follow-up in Study 2. Assessment Only: The Assessment Only condition receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6 month follow-up, and 12 month follow-up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Web-Based PFI | Participants randomized to the web-based PFI in Study 2 receive a 5 component Personalized Feedback Tool. The first component is presented immediately after the baseline survey and a link to each of the remaining 4 components is sent to participants spaced 1 to 2 weeks apart. The PFI components cover: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol. Each component is comprised of personalized feedback presented in text and graphic format, and each component includes links to tips for making changes if and when the participant is contemplating or ready to commit to change. These tips include general relapse prevention strategies, as well as information about the importance of regular class attendance, study habits, and sleep habits for academic success. General educational tips/strategies for time management, as well as tips for initiating behavior change are also included. Each component takes approximately 5-10 minutes to review. Web-based PFI: A web-based 5 component Personalized Feedback Tool covering content on: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol. |
| 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 | Change in Past 6 Month Non-Medical Use of Prescription Stimulant Medication Frequency | Assesses frequency of non-medical use of prescription stimulant medications. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Change in past 6 month number of days of nonmedical prescription stimulant use. | Posted | Mean | Standard Deviation | Usage days | Baseline and 6 months, Baseline and 12 months |
|
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 | Web-Based PFI | Participants randomized to the web-based PFI in Study 2 receive a 5 component Personalized Feedback Tool. The first component is presented immediately after the baseline survey and a link to each of the remaining 4 components is sent to participants spaced 1 to 2 weeks apart. The PFI components cover: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol. Each component is comprised of personalized feedback presented in text and graphic format, and each component includes links to tips for making changes if and when the participant is contemplating or ready to commit to change. These tips include general relapse prevention strategies, as well as information about the importance of regular class attendance, study habits, and sleep habits for academic success. General educational tips/strategies for time management, as well as tips for initiating behavior change are also included. Each component takes approximately 5-10 minutes to review. Web-based PFI: A web-based 5 component Personalized Feedback Tool covering content on: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Kilmer, Ph.D. | University of Washington | 206-685-4512 | jkilmer@uw.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 | Aug 23, 2019 | Jul 6, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 11, 2019 | Jul 6, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Assessment Only | Behavioral | The Assessment Only condition receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6 month follow-up, and 12 month follow-up. |
|
| Baseline and 6 months, Baseline and 12 months |
| Change in Past 6 Month Prescription Stimulant Use Consequence Questionnaire | Assesses negative consequences associated with prescription stimulant misuse over the previous 6 months. A score of "0" indicates that a given consequence did not occur and a score of "1" indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=19). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | 6 and 12 month follow-up |
| Change in Past 6 Month Daily Drinking Questionnaire | Assesses typical alcohol consumption over the course of a typical week. Responses for number of drinks consumed each day of a typical week were summed to create a summary score of total number of drinks consumed over a typical week. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months |
| Change in Past 6 Month Rutgers Alcohol Problem Index | Measures negative alcohol-related consequences experienced over the past 6 months. A score of "0" indicates that a given consequence did not occur and a score of "1" indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=26). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months |
| Change in Past Year, 6 Month, and 30 Day Marijuana Use Frequency | Items measure typical frequency of marijuana use and number of days used in the past year, 6 months, and 30 days. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months |
| Change in Past 6 Month Rutgers Marijuana Problem Index | Measures negative marijuana-related consequences experienced over the past 6 months. A score of "0" indicates that a given consequence did not occur and a score of "1" indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=26). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months |
| Change in Frequency of Past Month Alcohol Consumption | Assesses frequency (days) of alcohol consumption over the past month (min=0, max=31). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months |
| Change in Typical Quantity in Standard Drinks Consumed on a Typical Occasion in the Past Month | Assesses typical drinking quantity in standard drinks of alcohol consumed during a typical drinking occasion over the past month. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months |
| Baseline and 6 months, Baseline and 12 months |
| Change in Past Year Prescription Stimulant Norms Rating Form | Assesses the perceived percentage of students who have misused prescription stimulant medication in the past year. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months |
| Change in Current Semester/Quarter Motivated Strategies for Learning Questionnaire (MSLQ) | A 19-item abbreviated version of the Motivated Strategies for Learning Questionnaire was used to measures the use of different types of learning strategies and academic motivations during the current semester/quarter. Response options ranged from 1=Not at all true of me to 7=Very true of me. Mean scale scores were computed and change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Baseline and 6 months, Baseline and 12 months |
| Change in Cumulative and Last Semester/Quarter Grade Point Average (GPA) | Participants report their cumulative and previous semester/quarter GPA. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | 6 and 12 month follow-up |
| BG001 | Assessment Only | The Assessment Only group receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6-month follow-up, and 12-month follow-up in Study 2. Assessment Only: The Assessment Only condition receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6 month follow-up, and 12 month follow-up. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Assessment Only | The Assessment Only group receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6-month follow-up, and 12-month follow-up in Study 2. Assessment Only: The Assessment Only condition receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6 month follow-up, and 12 month follow-up. |
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| Primary | Change in Past 6 Month Medical Misuse of Prescription Stimulant Medication | Assesses past 6 month medical misuse of prescription stimulant medication. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | These analyses were limited to individuals who reported a diagnosis of ADHD (n=62). | Posted | Mean | Standard Deviation | Usage days | Baseline and 6 months, Baseline and 12 months |
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| Primary | Change in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool) | Assesses problematic use of tobacco, alcohol, prescription, and illicit drugs over the past year and 3 months. Response options included: 0= Never, 1= Less than Monthly, 2= Monthly, 3= Weekly, 4= Daily or Almost Daily. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 6 months, Baseline and 12 months |
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| Primary | Change in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants Only | Measures past 3 month non-medical use of prescription stimulants and associated negative consequences. Items were summed to create a scale summary score where higher values indicated more problematic use in the past 3 months (min=0, max=40). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 6 months, Baseline and 12 months |
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| Primary | Change in Past 6 Month Prescription Stimulant Use Consequence Questionnaire | Assesses negative consequences associated with prescription stimulant misuse over the previous 6 months. A score of "0" indicates that a given consequence did not occur and a score of "1" indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=19). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | Score on a scale | 6 and 12 month follow-up |
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| Secondary | Change in Peak Quantity of Alcohol Consumed in Past Month | Assesses quantity in standard drinks of peak drinking episode of alcohol consumption over the past month. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | standard drinks | Baseline and 6 months, Baseline and 12 months |
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| Secondary | Change in Past 6 Month Daily Drinking Questionnaire | Assesses typical alcohol consumption over the course of a typical week. Responses for number of drinks consumed each day of a typical week were summed to create a summary score of total number of drinks consumed over a typical week. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | Number of drinks | Baseline and 6 months, Baseline and 12 months |
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| Secondary | Change in Past 6 Month Rutgers Alcohol Problem Index | Measures negative alcohol-related consequences experienced over the past 6 months. A score of "0" indicates that a given consequence did not occur and a score of "1" indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=26). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 6 months, Baseline and 12 months |
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| Secondary | Change in Past Year, 6 Month, and 30 Day Marijuana Use Frequency | Items measure typical frequency of marijuana use and number of days used in the past year, 6 months, and 30 days. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | Usage days | Baseline and 6 months, Baseline and 12 months |
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| Secondary | Change in Past 6 Month Rutgers Marijuana Problem Index | Measures negative marijuana-related consequences experienced over the past 6 months. A score of "0" indicates that a given consequence did not occur and a score of "1" indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=26). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 6 months, Baseline and 12 months |
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| Other Pre-specified | Change in Past 6 Month Relapse Prevention/Protective Behaviors Scale | Measures the use of relapse prevention strategies and protective behaviors related to stimulant medication misuse. A score of "0" indicates that a given strategy did not occur and a score of "1" indicates that it did occur. Items were summed to create a scale summary score of overall number of unique relapse prevention/protective behavior strategies that occurred in the past 6 months (min=0, max=28). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 6 months, Baseline and 12 months |
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| Other Pre-specified | Change in Past Year Prescription Stimulant Norms Rating Form | Assesses the perceived percentage of students who have misused prescription stimulant medication in the past year. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | Percentage | Baseline and 6 months, Baseline and 12 months |
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| Other Pre-specified | Change in Current Semester/Quarter Motivated Strategies for Learning Questionnaire (MSLQ) | A 19-item abbreviated version of the Motivated Strategies for Learning Questionnaire was used to measures the use of different types of learning strategies and academic motivations during the current semester/quarter. Response options ranged from 1=Not at all true of me to 7=Very true of me. Mean scale scores were computed and change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 6 months, Baseline and 12 months |
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| Other Pre-specified | Change in Cumulative and Last Semester/Quarter Grade Point Average (GPA) | Participants report their cumulative and previous semester/quarter GPA. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | Score on a scale | 6 and 12 month follow-up |
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| Secondary | Change in Frequency of Past Month Alcohol Consumption | Assesses frequency (days) of alcohol consumption over the past month (min=0, max=31). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | Usage days | Baseline and 6 months, Baseline and 12 months |
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| Secondary | Change in Typical Quantity in Standard Drinks Consumed on a Typical Occasion in the Past Month | Assesses typical drinking quantity in standard drinks of alcohol consumed during a typical drinking occasion over the past month. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline). | Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants. | Posted | Mean | Standard Deviation | standard drinks | Baseline and 6 months, Baseline and 12 months |
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|
| 0 |
| 414 |
| 0 |
| 414 |
| 0 |
| 414 |
| EG001 | Assessment Only | The Assessment Only group receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6-month follow-up, and 12-month follow-up in Study 2. Assessment Only: The Assessment Only condition receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6 month follow-up, and 12 month follow-up. | 0 | 429 | 0 | 429 | 0 | 429 |
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Change in Medical Misuse of Prescription Stimulant Medication Among those with ADHD Diagnosis from Baseline to 12 Month Followup |
| Mixed Models Analysis |
Poisson Regression |
| .465 |
| Slope |
| -.336 |
| 2-Sided |
| 95 |
| -1.238 |
| .566 |
| Other |
General Linear Model |
| Change in Past 12 Month Tobacco Use at 12 Month Followup |
|
|
| Change in Past 12 Month Alcohol Use at 6 Month Followup |
|
|
| Change in Past 12 Month Alcohol Use at 12 Month Followup |
|
|
| Change in Past 12 Month Other Drug Use at 6 Month Followup |
|
|
| Change in Past 12 Month Other Drug Use at 12 Month Followup |
|
|
| Change in Past 12 Month Nonmedical Prescription Drug Use at 6 Month Followup |
|
|
| Change in Past 12 Month Nonmedical Prescription Drug Use at 12 Month Followup |
|
|
| Change in Past 3 Month Tobacco Use at 6 Month Followup |
|
|
| Change in Past 3 Month Tobacco Use at 12 Month Followup |
|
|
| Change in Past 3 Month Alcohol Use at 6 Month Followup |
|
|
| Change in Past 3 Month Alcohol Use at 12 Month Followup |
|
|
| Change in Past 3 Month Marijuana Use at 6 Month Followup |
|
|
| Change in Past 3 Month Marijuana Use at 12 Month Followup |
|
|
| Change in Past 3 Month Stimulant Use at 6 Month Followup |
|
|
| Change in Past 3 Month Stimulant Use at 12 Month Followup |
|
|
| Change in Past 3 Month Heroin Use at 6 Month Followup |
|
|
| Change in Past 3 Month Heroin Use at 12 Month Followup |
|
|
| Change in Past 3 Month Nonmedical Prescription Drug Use at 6 Month Followup |
|
|
| Change in Past 3 Month Nonmedical Prescription Drug Use at 12 Month Followup |
|
|
Change in Past 12 Month Tobacco Use from Baseline to 12 Month Followup |
| Mixed Models Analysis |
Negative Binomial Regression |
| .942 |
| Slope |
| .006 |
| 2-Sided |
| 95 |
| -.160 |
| .172 |
| Other |
General Linear Model |
| Change in Past 12 Month Alcohol Use from Baseline to 6 Month Followup | Mixed Models Analysis | Poisson Regression | .552 | Slope | -.042 | 2-Sided | 95 | -.180 | .097 | Other | General Linear Model |
| Change in Past 12 Month Alcohol Use from Baseline to 12 Month Followup | Mixed Models Analysis | Poisson Regression | .608 | Slope | .037 | 2-Sided | 95 | -.104 | .177 | Other | General Linear Model |
| Change in Past 12 Month Other Drug Use from Baseline to 6 Month Followup | Mixed Models Analysis | Poisson Regression | .840 | Slope | .015 | 2-Sided | 95 | -.130 | .160 | Other | General Linear Model |
| Change in Past 12 Month Other Drug Use from Baseline to 12 Month Followup | Mixed Models Analysis | Poisson Regression | .927 | Slope | .007 | 2-Sided | 95 | -.142 | .155 | Other | General Linear Model |
| Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followup | Mixed Models Analysis | Poisson Regression | .932 | Slope | -.010 | 2-Sided | 95 | -.244 | .223 | Other | General Linear Model |
| Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followup | Mixed Models Analysis | Poisson Regression | .648 | Slope | -.057 | 2-Sided | 95 | -.300 | 0.187 | Other | General Linear Model |
| Change in Past 3 Month Tobacco Use from Baseline to 6 Month Followup | Mixed Models Analysis | Poisson Regression | .702 | Slope | -.059 | 2-Sided | 95 | -.363 | .245 | Other | General Linear Model |
| Change in Past 3 Month Tobacco Use from Baseline to 12 Month Followup | Mixed Models Analysis | Poisson Regression | .524 | Slope | -.100 | 2-Sided | 95 | -.408 | .208 | Other | General Linear Model |
| Change in Past 3 Month Alcohol Use from Baseline to 6 Month Followup | Mixed Models Analysis | Poisson Regression | .913 | Slope | .008 | 2-Sided | 95 | -.137 | .153 | Other | General Linear Model |
| Change in Past 3 Month Alcohol Use from Baseline to 12 Month Followup | Mixed Models Analysis | Poisson Regresision | .676 | Slope | .032 | 2-Sided | 95 | -.117 | .181 | Other | General Linear Model |
| Change in Past 3 Month Marijuana Use from Baseline to 6 Month Followup | Mixed Models Analysis | Poisson Regression | .712 | Slope | -.035 | 2-Sided | 95 | -.223 | .152 | Other | General Linear Model |
| Change in Past 3 Month Marijuana Use from Baseline to 12 Month Followup | Mixed Models Analysis | Poisson Regression | .956 | Slope | .005 | 2-Sided | 95 | -.186 | 0.197 | Other | General Linear Model |
| Change in Past 3 Month Stimulant Use from Baseline to 6 Month Followup | Mixed Models Analysis | Poisson Regression | .446 | Slope | .149 | 2-Sided | 95 | -.234 | .531 | Other | General Linear Model |
| Change in Past 3 Month Stimulant Use from Baseline to 12 Month Followup | Mixed Models Analysis | Poisson Regression | .793 | Slope | .055 | 2-Sided | 95 | -.353 | .462 | Other | General Linear Model |
| Change in Past 3 Month Heroin Use from Baseline to 6 Month Followup | Mixed Models Analysis | Negative Binomial Regression | .999 | Slope | -.001 | 2-Sided | 95 | -2.005 | 2.003 | Other | General Linear Model |
| Change in Past 3 Month Heroin Use from Baseline to 12 Month Followup | Mixed Models Analysis | Negative Binomial Regression | .397 | Slope | .999 | 2-Sided | 95 | -1.312 | 3.310 | Other | General Linear Model |
| Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followup | Mixed Models Analysis | Negative Binomial Regression | .303 | Slope | .465 | 2-Sided | 95 | -.419 | 1.349 | Other | General Linear Model |
| Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followup | Mixed Models Analysis | Negative Binomial Regression | <.05 | Slope | .939 | 2-Sided | 95 | .128 | 1.751 | Other | General Linear Model |
| Change in ASSIST score at 12 month follow up |
|
|
Changes in ASSIST scores at 12 month follow up
| Mixed Models Analysis |
Negative Binomial Regression |
| 0.642 |
| Slope |
| -0.0601 |
| 2-Sided |
| 95 |
| -0.3133 |
| 0.1931 |
| Other |
General Linear Model |
| Change in consequence score at 12 months |
|
|
Change in consequence score at 12 month follow up
| Mixed Models Analysis |
Negative Binomial Regression |
| 0.351 |
| Slope |
| -0.1165 |
| 2-Sided |
| 95 |
| -0.3612 |
| 0.1282 |
| Other |
General Linear Model |
| Change in peak standard drink total at 12 months |
|
|
Change in peak alcohol quantity (reported in standard drinks) at 12 month follow-up |
| Mixed Models Analysis |
Negative Binomial Regression |
| 0.428 |
| Slope |
| 0.0315 |
| 2-Sided |
| 95 |
| -0.0463 |
| 0.1092 |
| Other |
General Linear Model |
| Change in DDQ score at 12 months |
|
|
Change in DDQ score at 12 month follow-up
| Mixed Models Analysis |
Negative Binomial Regression |
| 0.265 |
| Slope |
| -0.0559 |
| 2-Sided |
| 95 |
| -0.1542 |
| 0.0424 |
| Other |
General Linear Model |
| Change in RAPI score at 12 month follow up |
|
|
Change in RAPI count at 12 month follow-up
| Mixed Models Analysis |
Negative Binomial Regression |
| 0.573 |
| Slope |
| -0.0445 |
| 2-Sided |
| 95 |
| -0.1993 |
| 0.1102 |
| Other |
General Linear Model |
| Change in past year marijuana use at 12 month follow up |
|
|
| Change in past 6 month marijuana use at 6 month follow-up |
|
|
| Change in past 6 month marijuana use at 12 month follow-up |
|
|
| Change in past month marijuana use at 6 month follow-up |
|
|
| Change in past month marijuana use at 12 month follow-up |
|
|
Past 12 month marijuana use at 12 month follow-up
| Mixed Models Analysis |
Negative Binomial Regression |
| 0.816 |
| Slope |
| -0.0197 |
| 2-Sided |
| 95 |
| -0.1859 |
| 0.1465 |
| Other |
General Linear Model |
| Change in past 6 month marijuana use at 6 month follow-up | Mixed Models Analysis | Negative Binomial Regression | 0.209 | Slope | -0.1031 | 2-Sided | 95 | -0.2639 | 0.0577 | Other | General Linear Model |
| Change in past 6 month marijuana use at 12 month follow-up | Mixed Models Analysis | Negative Binomial Regression | 0.944 | Slope | -0.0060 | 2-Sided | 95 | -0.1729 | 0.1608 | Other | General Linear Model |
| Change in past month marijuana use at 6 month follow-up | Mixed Models Analysis | Negative Binomial Regression | 0.654 | Slope | -0.0391 | 2-Sided | 95 | -0.2102 | 0.1320 | Other | General Linear Model |
| Change in past month marijuana use at 12 month follow-up | Mixed Models Analysis | Negative Binomial Regression | 0.481 | Slope | -0.0646 | 2-Sided | 95 | -0.2444 | 0.1152 | Other | General Linear Model |
| Change in RMPI count at 12 month follow up |
|
|
Change in RMPI count at 12 month follow-up
| Mixed Models Analysis |
Negative Binomial Regression |
| 0.772 |
| Slope |
| 0.0177 |
| 2-Sided |
| 95 |
| -0.1021 |
| 0.1375 |
| Other |
General Linear Model |
| Change in PBS count at 12 month follow up |
|
|
Change in PBS count at 12 month follow up
| Mixed Models Analysis |
Negative Binomial Regression |
| 0.207 |
| Slope |
| 0.0936 |
| 2-Sided |
| 95 |
| -0.0517 |
| 0.2388 |
| Other |
General Linear Model |
| Change in perceived norm (in perceived past year days of use) at 12 month |
|
|
Change in perceived norm (perceived number of days of use in past year) at 12 month follow up |
| Mixed Models Analysis |
Negative Binomial Regression |
| <.003 |
| Slope |
| -0.1441 |
| 2-Sided |
| 95 |
| -0.2404 |
| -0.0478 |
| Other |
General Linear Model |
| Change in MSLQ score at 12 month follow up |
|
|
Change in MSLQ score at 12 month follow up
| Mixed Models Analysis |
Poisson regression |
| 0.784 |
| Slope |
| 0.0133 |
| 2-Sided |
| 95 |
| -0.0816 |
| 0.1081 |
| Other |
General Linear Model |
| Change in cumulative GPA at 12 month follow-up |
|
|
| Change in last term GPA at 6 month follow-up |
|
|
| Change in last term GPA at 12 month follow-up |
|
|
Change in cumulative grade point average at 12 month follow up
| Mixed Models Analysis |
General Linear Model |
| 0.871 |
| Slope |
| -0.0092 |
| 2-Sided |
| 95 |
| -0.1202 |
| 0.1018 |
| Other |
General Linear Model |
| Change in last term GPA at 6 month follow-up | Mixed Models Analysis | Poisson regression | 0.957 | Slope | 0.0030 | 2-Sided | 95 | -0.1063 | 0.1124 | Other | General Linear Model |
| Change in last term GPA at 12 month follow-up | Mixed Models Analysis | Poisson regression | 0.992 | Slope | 0.0006 | 2-Sided | 95 | -0.1098 | 0.1109 | Other | General Linear Model |
Change in past month alcohol frequency at 12 month follow-up
| Mixed Models Analysis |
Negative Binomial Regression |
| 0.443 |
| Slope |
| 0.0398 |
| 2-Sided |
| 95 |
| -0.0619 |
| 0.1414 |
| Other |
General Linear Model |
Change in past month typical alcohol quantity at 12 month follow-up
| Mixed Models Analysis |
Negative Binomial Regression |
| 0.808 |
| Slope |
| -0.0136 |
| 2-Sided |
| 95 |
| -0.1236 |
| 0.0963 |
| Other |
General Linear Model |