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Personalized Health Assessment Related to Medications (Project PHARM)

Primary Purpose

Feedback, Psychological, Clinical Trial, Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based PFI
Assessment Only
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feedback, Psychological

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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 exclusion criteria other than not meeting inclusion criteria.

Study 2 Inclusion Criteria:

  • Provides consent to participate
  • Currently enrolled as a student at one of the participating campuses and in their second semester/quarter or later
  • Has an anticipated graduation date at least 12 months into the future
  • Between 18-25 year olds
  • Misuse of prescription stimulants in the past year

Study 2 Exclusion Criteria:

  • There are no exclusion criteria other than not meeting inclusion criteria.

Study 3 Inclusion Criteria:

  • Provides consent to participate
  • Previous participation as a Study 2 participant.

Study 3 Exclusion Criteria:

  • There are no exclusion criteria other than not meeting inclusion criteria.

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Web-Based PFI

Assessment Only

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 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).
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).
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).
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).

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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).

Full Information

First Posted
January 5, 2017
Last Updated
July 7, 2023
Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03037476
Brief Title
Personalized Health Assessment Related to Medications (Project PHARM)
Official Title
Personalized Health Assessment Related to Medications (Project PHARM)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feedback, Psychological, Clinical Trial, Substance Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
843 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-Based PFI
Arm Type
Experimental
Arm Description
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.
Arm Title
Assessment Only
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Web-based PFI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Assessment Only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Past 6 Month Non-Medical Use of Prescription Stimulant Medication Frequency
Description
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
Title
Change in Past 6 Month Medical Misuse of Prescription Stimulant Medication
Description
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
Title
Change in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)
Description
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
Title
Change in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants Only
Description
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
Title
Change in Past 6 Month Prescription Stimulant Use Consequence Questionnaire
Description
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
Secondary Outcome Measure Information:
Title
Change in Peak Quantity of Alcohol Consumed in Past Month
Description
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
Title
Change in Past 6 Month Daily Drinking Questionnaire
Description
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
Title
Change in Past 6 Month Rutgers Alcohol Problem Index
Description
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
Title
Change in Past Year, 6 Month, and 30 Day Marijuana Use Frequency
Description
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
Title
Change in Past 6 Month Rutgers Marijuana Problem Index
Description
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
Title
Change in Frequency of Past Month Alcohol Consumption
Description
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
Title
Change in Typical Quantity in Standard Drinks Consumed on a Typical Occasion in the Past Month
Description
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
Other Pre-specified Outcome Measures:
Title
Change in Past 6 Month Relapse Prevention/Protective Behaviors Scale
Description
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
Title
Change in Past Year Prescription Stimulant Norms Rating Form
Description
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
Title
Change in Current Semester/Quarter Motivated Strategies for Learning Questionnaire (MSLQ)
Description
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
Title
Change in Cumulative and Last Semester/Quarter Grade Point Average (GPA)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 exclusion criteria other than not meeting inclusion criteria. Study 2 Inclusion Criteria: Provides consent to participate Currently enrolled as a student at one of the participating campuses and in their second semester/quarter or later Has an anticipated graduation date at least 12 months into the future Between 18-25 year olds Misuse of prescription stimulants in the past year Study 2 Exclusion Criteria: There are no exclusion criteria other than not meeting inclusion criteria. Study 3 Inclusion Criteria: Provides consent to participate Previous participation as a Study 2 participant. Study 3 Exclusion Criteria: There are no exclusion criteria other than not meeting inclusion criteria.
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Personalized Health Assessment Related to Medications (Project PHARM)

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