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Personalized Health Assessment Related to Medications (Project PHARM)

Personalized Health Assessment Related to Medications (Project PHARM)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03037476
Enrollment
843
Registered
2017-01-31
Start date
2017-03-30
Completion date
2021-12-15
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Trial, Feedback, Psychological, Substance Abuse

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALWeb-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.

BEHAVIORALAssessment 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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

Study 1 Inclusion Criteria: * Provides consent to participate * Currently enrolled as a student at one of the participating campuses * Between 18-25 year olds * Misuse of prescription stimulants in the past year Study 1

Exclusion criteria

* There are no

Design outcomes

Primary

MeasureTime frameDescription
Change in Past 6 Month Prescription Stimulant Use Consequence Questionnaire6 and 12 month follow-upAssesses 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).
Change in Past 6 Month Medical Misuse of Prescription Stimulant MedicationBaseline and 6 months, Baseline and 12 monthsAssesses 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).
Change in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants OnlyBaseline and 6 months, Baseline and 12 monthsMeasures 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).
Change in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Baseline and 6 months, Baseline and 12 monthsAssesses 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).
Change in Past 6 Month Non-Medical Use of Prescription Stimulant Medication FrequencyBaseline and 6 months, Baseline and 12 monthsAssesses 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).

Secondary

MeasureTime frameDescription
Change in Frequency of Past Month Alcohol ConsumptionBaseline and 6 months, Baseline and 12 monthsAssesses 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).
Change in Typical Quantity in Standard Drinks Consumed on a Typical Occasion in the Past MonthBaseline and 6 months, Baseline and 12 monthsAssesses 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).
Change in Past 6 Month Rutgers Marijuana Problem IndexBaseline and 6 months, Baseline and 12 monthsMeasures 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).
Change in Peak Quantity of Alcohol Consumed in Past MonthBaseline and 6 months, Baseline and 12 monthsAssesses 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).
Change in Past 6 Month Daily Drinking QuestionnaireBaseline and 6 months, Baseline and 12 monthsAssesses 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).
Change in Past 6 Month Rutgers Alcohol Problem IndexBaseline and 6 months, Baseline and 12 monthsMeasures 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).
Change in Past Year, 6 Month, and 30 Day Marijuana Use FrequencyBaseline and 6 months, Baseline and 12 monthsItems 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).

Other

MeasureTime frameDescription
Change in Past 6 Month Relapse Prevention/Protective Behaviors ScaleBaseline and 6 months, Baseline and 12 monthsMeasures 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).
Change in Cumulative and Last Semester/Quarter Grade Point Average (GPA)6 and 12 month follow-upParticipants 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).
Change in Current Semester/Quarter Motivated Strategies for Learning Questionnaire (MSLQ)Baseline and 6 months, Baseline and 12 monthsA 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).
Change in Past Year Prescription Stimulant Norms Rating FormBaseline and 6 months, Baseline and 12 monthsAssesses 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
414
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.
429
Total843

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up6346

Baseline characteristics

CharacteristicWeb-Based PFIAssessment OnlyTotal
Age, Categorical
<=18 years
45 Participants31 Participants76 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
369 Participants398 Participants767 Participants
Age, Continuous19.82 years
STANDARD_DEVIATION 1.12
19.95 years
STANDARD_DEVIATION 1.05
19.88 years
STANDARD_DEVIATION 1.09
Ethnicity (NIH/OMB)
Hispanic or Latino
46 Participants41 Participants87 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
366 Participants388 Participants754 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants3 Participants5 Participants
Race (NIH/OMB)
Asian
81 Participants88 Participants169 Participants
Race (NIH/OMB)
Black or African American
21 Participants16 Participants37 Participants
Race (NIH/OMB)
More than one race
31 Participants32 Participants63 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants3 Participants4 Participants
Race (NIH/OMB)
Unknown or Not Reported
15 Participants11 Participants26 Participants
Race (NIH/OMB)
White
263 Participants276 Participants539 Participants
Region of Enrollment
United States
414 participants429 participants843 participants
Sex: Female, Male
Female
258 Participants248 Participants506 Participants
Sex: Female, Male
Male
156 Participants181 Participants337 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 4140 / 429
other
Total, other adverse events
0 / 4140 / 429
serious
Total, serious adverse events
0 / 4140 / 429

Outcome results

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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants OnlyChange in ASSIST score at 6 month follow up-1.420 Score on a scaleStandard Deviation 4.59
Web-Based PFIChange in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants OnlyChange in ASSIST score at 12 month follow up-1.26 Score on a scaleStandard Deviation 5.35
Assessment OnlyChange in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants OnlyChange in ASSIST score at 6 month follow up-1.08 Score on a scaleStandard Deviation 5.02
Assessment OnlyChange in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants OnlyChange in ASSIST score at 12 month follow up-1.19 Score on a scaleStandard Deviation 5.24
Comparison: Change in ASSIST Score over time: 6 month follow upp-value: 0.15195% CI: [-0.4295, 0.0663]Mixed Models Analysis
Comparison: Changes in ASSIST scores at 12 month follow upp-value: 0.64295% CI: [-0.3133, 0.1931]Mixed Models Analysis
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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: These analyses were limited to individuals who reported a diagnosis of ADHD (n=62).

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Past 6 Month Medical Misuse of Prescription Stimulant Medication6 Month Follow-up-.30 Usage daysStandard Deviation 0.72
Web-Based PFIChange in Past 6 Month Medical Misuse of Prescription Stimulant Medication12 Month Follow-up-.19 Usage daysStandard Deviation 0.74
Assessment OnlyChange in Past 6 Month Medical Misuse of Prescription Stimulant Medication6 Month Follow-up-.03 Usage daysStandard Deviation 0.62
Assessment OnlyChange in Past 6 Month Medical Misuse of Prescription Stimulant Medication12 Month Follow-up-.07 Usage daysStandard Deviation 0.66
Comparison: Change in Medical Misuse of Prescription Stimulant Medication Among those with ADHD Diagnosis from Baseline to 6 Month Followupp-value: 0.60395% CI: [-1.12, 0.65]Mixed Models Analysis
Comparison: Change in Medical Misuse of Prescription Stimulant Medication Among those with ADHD Diagnosis from Baseline to 12 Month Followupp-value: 0.46595% CI: [-1.238, 0.566]Mixed Models Analysis
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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: Change in past 6 month number of days of nonmedical prescription stimulant use.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Past 6 Month Non-Medical Use of Prescription Stimulant Medication Frequency6 Month Follow-up-2.04 Usage daysStandard Deviation 5.72
Web-Based PFIChange in Past 6 Month Non-Medical Use of Prescription Stimulant Medication Frequency12 Month Follow-up-1.03 Usage daysStandard Deviation 7.91
Assessment OnlyChange in Past 6 Month Non-Medical Use of Prescription Stimulant Medication Frequency6 Month Follow-up-1.72 Usage daysStandard Deviation 6.88
Assessment OnlyChange in Past 6 Month Non-Medical Use of Prescription Stimulant Medication Frequency12 Month Follow-up-.38 Usage daysStandard Deviation 11.45
Comparison: Changes from Baseline to 6 Month Follow-up Outcomes reported in this section.p-value: 0.0395% CI: [-0.446, -0.023]Mixed Models Analysis
Comparison: Changes from Baseline to 12 Month Follow-up reported in this section.p-value: 0.16495% CI: [-0.36, 0.061]Mixed Models Analysis
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).

Time frame: 6 and 12 month follow-up

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Past 6 Month Prescription Stimulant Use Consequence QuestionnaireChange in consequence score at 6 months-1.27 Score on a scaleStandard Deviation 3.8
Web-Based PFIChange in Past 6 Month Prescription Stimulant Use Consequence QuestionnaireChange in consequence score at 12 months-0.92 Score on a scaleStandard Deviation 4.15
Assessment OnlyChange in Past 6 Month Prescription Stimulant Use Consequence QuestionnaireChange in consequence score at 6 months-1.07 Score on a scaleStandard Deviation 3.65
Assessment OnlyChange in Past 6 Month Prescription Stimulant Use Consequence QuestionnaireChange in consequence score at 12 months-1.11 Score on a scaleStandard Deviation 4.16
Comparison: Change in consequence score at 6 month follow upp-value: 0.07495% CI: [-0.4566, 0.0213]Mixed Models Analysis
Comparison: Change in consequence score at 12 month follow upp-value: 0.35195% CI: [-0.3612, 0.1282]Mixed Models Analysis
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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Tobacco Use at 12 Month Followup0.15 Score on a scaleStandard Deviation 1.35
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Alcohol Use at 12 Month Followup-.90 Score on a scaleStandard Deviation 0.81
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Other Drug Use at 12 Month Followup-.17 Score on a scaleStandard Deviation 1.25
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Other Drug Use at 6 Month Followup-.16 Score on a scaleStandard Deviation 1.14
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Nonmedical Prescription Drug Use at 6 Month Followup-.26 Score on a scaleStandard Deviation 0.87
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Stimulant Use at 12 Month Followup-.09 Score on a scaleStandard Deviation 0.66
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Tobacco Use at 6 Month Followup-.04 Score on a scaleStandard Deviation 0.59
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Nonmedical Prescription Drug Use at 12 Month Followup-.3 Score on a scaleStandard Deviation 0.97
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Tobacco Use at 12 Month Followup-.05 Score on a scaleStandard Deviation 0.61
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Heroin Use at 12 Month Followup.01 Score on a scaleStandard Deviation 0.28
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Marijuana Use at 6 Month Followup-.12 Score on a scaleStandard Deviation 0.76
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Alcohol Use at 6 Month Followup-.12 Score on a scaleStandard Deviation 0.9
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Marijuana Use at 12 Month Followup-.06 Score on a scaleStandard Deviation 0.8
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Nonmedical Prescription Drug Use at 6 Month Followup-.01 Score on a scaleStandard Deviation 0.26
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Stimulant Use at 6 Month Followup-.02 Score on a scaleStandard Deviation 0.58
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Alcohol Use at 6 Month Followup-.05 Score on a scaleStandard Deviation 0.78
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Heroin Use at 6 Month Followup.01 Score on a scaleStandard Deviation 0.26
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Alcohol Use at 12 Month Followup-.09 Score on a scaleStandard Deviation 0.89
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Nonmedical Prescription Drug Use at 12 Month Followup.04 Score on a scaleStandard Deviation 0.41
Web-Based PFIChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Tobacco Use at 6 Month Followup-.03 Score on a scaleStandard Deviation 1.22
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Nonmedical Prescription Drug Use at 12 Month Followup-.03 Score on a scaleStandard Deviation 0.36
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Tobacco Use at 6 Month Followup.06 Score on a scaleStandard Deviation 0.98
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Tobacco Use at 12 Month Followup0.15 Score on a scaleStandard Deviation 1.18
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Alcohol Use at 6 Month Followup-.02 Score on a scaleStandard Deviation 0.83
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Nonmedical Prescription Drug Use at 12 Month Followup-.28 Score on a scaleStandard Deviation 0.92
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Alcohol Use at 6 Month Followup-.1 Score on a scaleStandard Deviation 0.8
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Alcohol Use at 12 Month Followup-.19 Score on a scaleStandard Deviation 0.92
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Stimulant Use at 12 Month Followup-.11 Score on a scaleStandard Deviation 0.7
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Heroin Use at 12 Month Followup-.01 Score on a scaleStandard Deviation 0.15
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Nonmedical Prescription Drug Use at 6 Month Followup-.04 Score on a scaleStandard Deviation 0.35
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Alcohol Use at 12 Month Followup-.1 Score on a scaleStandard Deviation 0.93
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Other Drug Use at 6 Month Followup-.18 Score on a scaleStandard Deviation 1.08
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Other Drug Use at 12 Month Followup-.22 Score on a scaleStandard Deviation 1.22
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 12 Month Nonmedical Prescription Drug Use at 6 Month Followup-.24 Score on a scaleStandard Deviation 0.91
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Tobacco Use at 6 Month Followup0 Score on a scaleStandard Deviation 0.53
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Tobacco Use at 12 Month Followup.01 Score on a scaleStandard Deviation 0.56
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Marijuana Use at 6 Month Followup-.04 Score on a scaleStandard Deviation 0.77
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Marijuana Use at 12 Month Followup-.09 Score on a scaleStandard Deviation 0.87
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Stimulant Use at 6 Month Followup-.08 Score on a scaleStandard Deviation 0.61
Assessment OnlyChange in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)Change in Past 3 Month Heroin Use at 6 Month Followup.01 Score on a scaleStandard Deviation 0.15
Comparison: Change in Past 12 Month Tobacco Use from Baseline to 6 Month Followupp-value: 0.48695% CI: [-0.227, 0.108]Mixed Models Analysis
Comparison: Change in Past 12 Month Tobacco Use from Baseline to 12 Month Followupp-value: 0.94295% CI: [-0.16, 0.172]Mixed Models Analysis
Comparison: Change in Past 12 Month Alcohol Use from Baseline to 6 Month Followupp-value: 0.55295% CI: [-0.18, 0.097]Mixed Models Analysis
Comparison: Change in Past 12 Month Alcohol Use from Baseline to 12 Month Followupp-value: 0.60895% CI: [-0.104, 0.177]Mixed Models Analysis
Comparison: Change in Past 12 Month Other Drug Use from Baseline to 6 Month Followupp-value: 0.8495% CI: [-0.13, 0.16]Mixed Models Analysis
Comparison: Change in Past 12 Month Other Drug Use from Baseline to 12 Month Followupp-value: 0.92795% CI: [-0.142, 0.155]Mixed Models Analysis
Comparison: Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followupp-value: 0.93295% CI: [-0.244, 0.223]Mixed Models Analysis
Comparison: Change in Past 12 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followupp-value: 0.64895% CI: [-0.3, 0.187]Mixed Models Analysis
Comparison: Change in Past 3 Month Tobacco Use from Baseline to 6 Month Followupp-value: 0.70295% CI: [-0.363, 0.245]Mixed Models Analysis
Comparison: Change in Past 3 Month Tobacco Use from Baseline to 12 Month Followupp-value: 0.52495% CI: [-0.408, 0.208]Mixed Models Analysis
Comparison: Change in Past 3 Month Alcohol Use from Baseline to 6 Month Followupp-value: 0.91395% CI: [-0.137, 0.153]Mixed Models Analysis
Comparison: Change in Past 3 Month Alcohol Use from Baseline to 12 Month Followupp-value: 0.67695% CI: [-0.117, 0.181]Mixed Models Analysis
Comparison: Change in Past 3 Month Marijuana Use from Baseline to 6 Month Followupp-value: 0.71295% CI: [-0.223, 0.152]Mixed Models Analysis
Comparison: Change in Past 3 Month Marijuana Use from Baseline to 12 Month Followupp-value: 0.95695% CI: [-0.186, 0.197]Mixed Models Analysis
Comparison: Change in Past 3 Month Stimulant Use from Baseline to 6 Month Followupp-value: 0.44695% CI: [-0.234, 0.531]Mixed Models Analysis
Comparison: Change in Past 3 Month Stimulant Use from Baseline to 12 Month Followupp-value: 0.79395% CI: [-0.353, 0.462]Mixed Models Analysis
Comparison: Change in Past 3 Month Heroin Use from Baseline to 6 Month Followupp-value: 0.99995% CI: [-2.005, 2.003]Mixed Models Analysis
Comparison: Change in Past 3 Month Heroin Use from Baseline to 12 Month Followupp-value: 0.39795% CI: [-1.312, 3.31]Mixed Models Analysis
Comparison: Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 6 Month Followupp-value: 0.30395% CI: [-0.419, 1.349]Mixed Models Analysis
Comparison: Change in Past 3 Month Nonmedical Prescription Drug Use from Baseline to 12 Month Followupp-value: <0.0595% CI: [0.128, 1.751]Mixed Models Analysis
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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Frequency of Past Month Alcohol ConsumptionChange in past month frequency alcohol at 6 months-1.21 Usage daysStandard Deviation 4.94
Web-Based PFIChange in Frequency of Past Month Alcohol ConsumptionChange in past month alcohol frequency at 12 months-1.04 Usage daysStandard Deviation 5.63
Assessment OnlyChange in Frequency of Past Month Alcohol ConsumptionChange in past month frequency alcohol at 6 months-1.61 Usage daysStandard Deviation 5.45
Assessment OnlyChange in Frequency of Past Month Alcohol ConsumptionChange in past month alcohol frequency at 12 months-1.30 Usage daysStandard Deviation 6.36
Comparison: Change in past month alcohol frequency at 6 month follow-upp-value: 0.44795% CI: [-0.0615, 0.1395]Mixed Models Analysis
Comparison: Change in past month alcohol frequency at 12 month follow-upp-value: 0.44395% CI: [-0.0619, 0.1414]Mixed Models Analysis
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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Past 6 Month Daily Drinking QuestionnaireChange in DDQ score at 12 months-2.81 Number of drinksStandard Deviation 8.6
Web-Based PFIChange in Past 6 Month Daily Drinking QuestionnaireChange in DDQ score at 6 months-2.09 Number of drinksStandard Deviation 6.92
Assessment OnlyChange in Past 6 Month Daily Drinking QuestionnaireChange in DDQ score at 12 months-2.07 Number of drinksStandard Deviation 8.59
Assessment OnlyChange in Past 6 Month Daily Drinking QuestionnaireChange in DDQ score at 6 months-2.11 Number of drinksStandard Deviation 7.22
Comparison: Change in DDQ score at 6 monthsp-value: 0.96695% CI: [-0.0936, 0.0978]Mixed Models Analysis
Comparison: Change in DDQ score at 12 month follow-upp-value: 0.26595% CI: [-0.1542, 0.0424]Mixed Models Analysis
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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Past 6 Month Rutgers Alcohol Problem IndexChange in RAPI score at 6 month follow up-1.66 Score on a scaleStandard Deviation 5.06
Web-Based PFIChange in Past 6 Month Rutgers Alcohol Problem IndexChange in RAPI score at 12 month follow up-1.47 Score on a scaleStandard Deviation 5.71
Assessment OnlyChange in Past 6 Month Rutgers Alcohol Problem IndexChange in RAPI score at 6 month follow up-1.42 Score on a scaleStandard Deviation 4.44
Assessment OnlyChange in Past 6 Month Rutgers Alcohol Problem IndexChange in RAPI score at 12 month follow up-1.21 Score on a scaleStandard Deviation 4.94
Comparison: Change in RAPI count at 6 month follow-upp-value: 0.86895% CI: [-0.1633, 0.1378]Mixed Models Analysis
Comparison: Change in RAPI count at 12 month follow-upp-value: 0.57395% CI: [-0.1993, 0.1102]Mixed Models Analysis
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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Past 6 Month Rutgers Marijuana Problem IndexChange in RMPI count at 6 month follow up-0.81 Score on a scaleStandard Deviation 6.13
Web-Based PFIChange in Past 6 Month Rutgers Marijuana Problem IndexChange in RMPI count at 12 month follow up-0.81 Score on a scaleStandard Deviation 6
Assessment OnlyChange in Past 6 Month Rutgers Marijuana Problem IndexChange in RMPI count at 6 month follow up-0.66 Score on a scaleStandard Deviation 5.53
Assessment OnlyChange in Past 6 Month Rutgers Marijuana Problem IndexChange in RMPI count at 12 month follow up-1.01 Score on a scaleStandard Deviation 6.2
Comparison: Change in RMPI count at 6 month follow-upp-value: 0.48795% CI: [-0.1569, 0.0747]Mixed Models Analysis
Comparison: Change in RMPI count at 12 month follow-upp-value: 0.77295% CI: [-0.1021, 0.1375]Mixed Models Analysis
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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Past Year, 6 Month, and 30 Day Marijuana Use FrequencyChange in past month marijuana use at 12 month follow-up-0.53 Usage daysStandard Deviation 8.56
Web-Based PFIChange in Past Year, 6 Month, and 30 Day Marijuana Use FrequencyChange in past 6 month marijuana use at 12 month follow-up2.22 Usage daysStandard Deviation 41.52
Web-Based PFIChange in Past Year, 6 Month, and 30 Day Marijuana Use FrequencyChange in past month marijuana use at 6 month follow-up-0.07 Usage daysStandard Deviation 7.22
Web-Based PFIChange in Past Year, 6 Month, and 30 Day Marijuana Use FrequencyChange in past year marijuana use at 12 month follow up3.90 Usage daysStandard Deviation 84
Web-Based PFIChange in Past Year, 6 Month, and 30 Day Marijuana Use FrequencyChange in past 6 month marijuana use at 6 month follow-up0.49 Usage daysStandard Deviation 36.58
Web-Based PFIChange in Past Year, 6 Month, and 30 Day Marijuana Use FrequencyChange in past year marijuana use at 6 month follow up2.22 Usage daysStandard Deviation 72.74
Assessment OnlyChange in Past Year, 6 Month, and 30 Day Marijuana Use FrequencyChange in past 6 month marijuana use at 6 month follow-up1.69 Usage daysStandard Deviation 34.04
Assessment OnlyChange in Past Year, 6 Month, and 30 Day Marijuana Use FrequencyChange in past year marijuana use at 12 month follow up0.35 Usage daysStandard Deviation 87.6
Assessment OnlyChange in Past Year, 6 Month, and 30 Day Marijuana Use FrequencyChange in past 6 month marijuana use at 12 month follow-up-0.57 Usage daysStandard Deviation 42
Assessment OnlyChange in Past Year, 6 Month, and 30 Day Marijuana Use FrequencyChange in past month marijuana use at 6 month follow-up0.00 Usage daysStandard Deviation 7.33
Assessment OnlyChange in Past Year, 6 Month, and 30 Day Marijuana Use FrequencyChange in past month marijuana use at 12 month follow-up-0.39 Usage daysStandard Deviation 8.47
Assessment OnlyChange in Past Year, 6 Month, and 30 Day Marijuana Use FrequencyChange in past year marijuana use at 6 month follow up3.60 Usage daysStandard Deviation 66.67
Comparison: Change in past month marijuana use at 6 month follow-upp-value: 0.65495% CI: [-0.2102, 0.132]Mixed Models Analysis
Comparison: Change in past 12 month marijuana use at 6 month follow-upp-value: 0.26695% CI: [-0.2484, 0.0685]Mixed Models Analysis
Comparison: Past 12 month marijuana use at 12 month follow-upp-value: 0.81695% CI: [-0.1859, 0.1465]Mixed Models Analysis
Comparison: Change in past 6 month marijuana use at 6 month follow-upp-value: 0.20995% CI: [-0.2639, 0.0577]Mixed Models Analysis
Comparison: Change in past 6 month marijuana use at 12 month follow-upp-value: 0.94495% CI: [-0.1729, 0.1608]Mixed Models Analysis
Comparison: Change in past month marijuana use at 12 month follow-upp-value: 0.48195% CI: [-0.2444, 0.1152]Mixed Models Analysis
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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Peak Quantity of Alcohol Consumed in Past MonthChange in peak standard drink total at 12 months-1.26 standard drinksStandard Deviation 3.82
Web-Based PFIChange in Peak Quantity of Alcohol Consumed in Past MonthChange in peak alcohol standard drink total at 6 months-0.94 standard drinksStandard Deviation 3.71
Assessment OnlyChange in Peak Quantity of Alcohol Consumed in Past MonthChange in peak alcohol standard drink total at 6 months-1.23 standard drinksStandard Deviation 4.14
Assessment OnlyChange in Peak Quantity of Alcohol Consumed in Past MonthChange in peak standard drink total at 12 months-1.48 standard drinksStandard Deviation 4.53
Comparison: Change in peak alcohol quantity at 6 months (reported by number of standard drinks)p-value: 0.25595% CI: [-0.032, 0.1197]Mixed Models Analysis
Comparison: Change in peak alcohol quantity (reported in standard drinks) at 12 month follow-upp-value: 0.42895% CI: [-0.0463, 0.1092]Mixed Models Analysis
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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Typical Quantity in Standard Drinks Consumed on a Typical Occasion in the Past MonthChange in past month typical quantity at 6 months-1.47 standard drinksStandard Deviation 3.82
Web-Based PFIChange in Typical Quantity in Standard Drinks Consumed on a Typical Occasion in the Past MonthChange in past month typical quantity at 12 months-1.90 standard drinksStandard Deviation 4.16
Assessment OnlyChange in Typical Quantity in Standard Drinks Consumed on a Typical Occasion in the Past MonthChange in past month typical quantity at 6 months-1.40 standard drinksStandard Deviation 3.89
Assessment OnlyChange in Typical Quantity in Standard Drinks Consumed on a Typical Occasion in the Past MonthChange in past month typical quantity at 12 months-1.57 standard drinksStandard Deviation 4.42
Comparison: Change in past month alcohol typical quantity at 6 monthsp-value: 0.99795% CI: [-0.1066, 0.107]Mixed Models Analysis
Comparison: Change in past month typical alcohol quantity at 12 month follow-upp-value: 0.80895% CI: [-0.1236, 0.0963]Mixed Models Analysis
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).

Time frame: 6 and 12 month follow-up

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Cumulative and Last Semester/Quarter Grade Point Average (GPA)Change in cumulative GPA at 6 month follow up0.01 Score on a scaleStandard Deviation 0.21
Web-Based PFIChange in Cumulative and Last Semester/Quarter Grade Point Average (GPA)Change in last term GPA at 12 month follow-up0.05 Score on a scaleStandard Deviation 0.5
Web-Based PFIChange in Cumulative and Last Semester/Quarter Grade Point Average (GPA)Change in cumulative GPA at 12 month follow-up0.02 Score on a scaleStandard Deviation 0.26
Web-Based PFIChange in Cumulative and Last Semester/Quarter Grade Point Average (GPA)Change in last term GPA at 6 month follow-up0.05 Score on a scaleStandard Deviation 0.45
Assessment OnlyChange in Cumulative and Last Semester/Quarter Grade Point Average (GPA)Change in last term GPA at 12 month follow-up0.24 Score on a scaleStandard Deviation 0.48
Assessment OnlyChange in Cumulative and Last Semester/Quarter Grade Point Average (GPA)Change in last term GPA at 6 month follow-up0.01 Score on a scaleStandard Deviation 0.45
Assessment OnlyChange in Cumulative and Last Semester/Quarter Grade Point Average (GPA)Change in cumulative GPA at 12 month follow-up0.03 Score on a scaleStandard Deviation 0.24
Assessment OnlyChange in Cumulative and Last Semester/Quarter Grade Point Average (GPA)Change in cumulative GPA at 6 month follow up-0.002 Score on a scaleStandard Deviation 0.2
Comparison: Change in cumulative grade point average at 6 month follow upp-value: 0.91495% CI: [-0.1161, 0.104]Mixed Models Analysis
Comparison: Change in cumulative grade point average at 12 month follow upp-value: 0.87195% CI: [-0.1202, 0.1018]Mixed Models Analysis
Comparison: Change in last term GPA at 6 month follow-upp-value: 0.95795% CI: [-0.1063, 0.1124]Mixed Models Analysis
Comparison: Change in last term GPA at 12 month follow-upp-value: 0.99295% CI: [-0.1098, 0.1109]Mixed Models Analysis
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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Current Semester/Quarter Motivated Strategies for Learning Questionnaire (MSLQ)Change in MSLQ score at 6 month follow up-0.10 Score on a scaleStandard Deviation 1.07
Web-Based PFIChange in Current Semester/Quarter Motivated Strategies for Learning Questionnaire (MSLQ)Change in MSLQ score at 12 month follow up-0.01 Score on a scaleStandard Deviation 1.06
Assessment OnlyChange in Current Semester/Quarter Motivated Strategies for Learning Questionnaire (MSLQ)Change in MSLQ score at 6 month follow up-0.08 Score on a scaleStandard Deviation 0.95
Assessment OnlyChange in Current Semester/Quarter Motivated Strategies for Learning Questionnaire (MSLQ)Change in MSLQ score at 12 month follow up-0.1 Score on a scaleStandard Deviation 1.09
Comparison: Change in MSLQ score at 6 month follow-upp-value: 0.74395% CI: [-0.1096, 0.0782]Mixed Models Analysis
Comparison: Change in MSLQ score at 12 month follow upp-value: 0.78495% CI: [-0.0816, 0.1081]Mixed Models Analysis
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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Past 6 Month Relapse Prevention/Protective Behaviors ScaleChange in PBS count at 6 month follow up-0.32 Score on a scaleStandard Deviation 6.03
Web-Based PFIChange in Past 6 Month Relapse Prevention/Protective Behaviors ScaleChange in PBS count at 12 month follow up-0.77 Score on a scaleStandard Deviation 7.36
Assessment OnlyChange in Past 6 Month Relapse Prevention/Protective Behaviors ScaleChange in PBS count at 6 month follow up-1.40 Score on a scaleStandard Deviation 6.62
Assessment OnlyChange in Past 6 Month Relapse Prevention/Protective Behaviors ScaleChange in PBS count at 12 month follow up-1.30 Score on a scaleStandard Deviation 6.8
Comparison: Change in PBS count at 6 month follow upp-value: 0.07595% CI: [-0.0131, 0.2702]Mixed Models Analysis
Comparison: Change in PBS count at 12 month follow upp-value: 0.20795% CI: [-0.0517, 0.2388]Mixed Models Analysis
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).

Time frame: Baseline and 6 months, Baseline and 12 months

Population: Difference in number analyzed by condition are due to differences in follow-up participation rates and/or items skipped by participants.

ArmMeasureGroupValue (MEAN)Dispersion
Web-Based PFIChange in Past Year Prescription Stimulant Norms Rating FormChange in perceived norm (in perceived past year days of use) at 6 month-9.29 PercentageStandard Deviation 19.37
Web-Based PFIChange in Past Year Prescription Stimulant Norms Rating FormChange in perceived norm (in perceived past year days of use) at 12 month-11.10 PercentageStandard Deviation 20.99
Assessment OnlyChange in Past Year Prescription Stimulant Norms Rating FormChange in perceived norm (in perceived past year days of use) at 6 month-4.11 PercentageStandard Deviation 20.44
Assessment OnlyChange in Past Year Prescription Stimulant Norms Rating FormChange in perceived norm (in perceived past year days of use) at 12 month-6.36 PercentageStandard Deviation 18.5
Comparison: Change in perceived norm (in perceived days of use in past year) at 6 month follow upp-value: <0.00195% CI: [-0.2525, -0.0683]Mixed Models Analysis
Comparison: Change in perceived norm (perceived number of days of use in past year) at 12 month follow upp-value: <0.00395% CI: [-0.2404, -0.0478]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026