Personalized Health Assessment Related to Medications (Project PHARM)
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 25 |
| Updated: | 5/6/2018 |
| Start Date: | January 2017 |
| End Date: | June 2019 |
| Contact: | Irene M Geisner, Ph.D. |
| Email: | geisner@uw.edu |
| Phone: | 206-419-8999 |
This research will adapt an evidence based intervention for alcohol and other drugs and
evaluate its efficacy on Prescription Stimulant Medication (PSM) misuse in web-based and
in-person formats for use with college students who have misused PSMs.
evaluate its efficacy on Prescription Stimulant Medication (PSM) misuse in web-based and
in-person formats 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) Conduct
screening and RCT through a university counseling center and healthcare center utilizing
in-person and web-based PSM interventions compared to control.
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, Study 3 entails conducting screening and a RCT through a university counseling center
and healthcare center. Eligible students will be randomized to one of 3 conditions: in-person
PFI, web-based PFI, or control. Both of the interventions aim to reduce perceived benefits of
PSM, normative perceptions of PSM, and increase alternative behaviors, thereby reducing PSM
and other substance use (specifically marijuana and alcohol). Participants complete a
follow-up assessment at 6 months post-baseline to evaluate intervention efficacy. The
investigators hypothesize: 1) both web- and in-person PFI will be more efficacious than
control, 2) the in-person intervention will be more efficacious than web at 6 month
follow-up, and 3) reductions in perceived benefits and norms of PSM and increases in
alternative behaviors will mediate efficacy of both interventions, as will reductions in
alcohol and marijuana use. Demographics and PSM motives will be explored as moderators of
overall and differential efficacy.
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) Conduct
screening and RCT through a university counseling center and healthcare center utilizing
in-person and web-based PSM interventions compared to control.
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, Study 3 entails conducting screening and a RCT through a university counseling center
and healthcare center. Eligible students will be randomized to one of 3 conditions: in-person
PFI, web-based PFI, or control. Both of the interventions aim to reduce perceived benefits of
PSM, normative perceptions of PSM, and increase alternative behaviors, thereby reducing PSM
and other substance use (specifically marijuana and alcohol). Participants complete a
follow-up assessment at 6 months post-baseline to evaluate intervention efficacy. The
investigators hypothesize: 1) both web- and in-person PFI will be more efficacious than
control, 2) the in-person intervention will be more efficacious than web at 6 month
follow-up, and 3) reductions in perceived benefits and norms of PSM and increases in
alternative behaviors will mediate efficacy of both interventions, as will reductions in
alcohol and marijuana use. Demographics and PSM motives will be explored as moderators of
overall and differential efficacy.
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
- Currently enrolled as a student at the participating campus and in their second
semester/quarter or later.
- Has an anticipated graduation date at least 6 months into the future
- Between 18-25 year olds
- Misuse of prescription stimulants in the past year
Study 3 Exclusion Criteria:
- There are no exclusion criteria other than not meeting inclusion criteria.
We found this trial at
1
site
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Irene M Geisner, Ph.D.
Phone: 206-419-8999
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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