- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00078273
Indicated Prevention With At-Risk Gamblers
December 10, 2013 updated by: Mary Larimer, University of Washington
The overall purpose of this study is to reduce the prevalence of gambling risk in college students by evaluating the effectiveness of different treatments in reducing gambling behavior and related negative consequences.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants in this study will be randomly assigned to a personal feedback intervention (PFI) or assessment only for 3 years.
The PFI intervention will be delivered in a single session.
Measures will include the NORC DSM Screen for Problem Gambling (NODS), the South Oaks Gambling Screen (SOGS), Gambling Quantity and Perceived Norms, Perceived Injunctive Gambling Norms, Gambling Problems Index, gambling frequency, attitudes and beliefs about gambling and self-control, readiness to change, gambling expectancies, gambling motives, gambling risk perception, psychiatric symptoms, assertiveness, coping skills, substance use, alcohol-related problems, self-determination, and social desirability.
Study Type
Interventional
Enrollment (Actual)
225
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington; Department of Psychiatry and Behavioral Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- College student
- South Oaks Gambling Screen (SOGS) score greater than 3
Exclusion Criteria:
- None, other than not meeting inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Assessment Only Control
Completed Baseline and 6 month follow-up surveys only.
|
|
Experimental: Personalized Feedback Intervention
See Intervention Description
|
Sessions lasted for 60-90 minutes and used Motivational Interviewing (MI) to facilitate discussion of feedback from participants' survey responses.
Sessions began with open-ended questions about contextual factors associated with participants' gambling, then review of each feedback section: gambling pattern; perceived gambling norms; positive expectancies and negative consequences of gambling; beliefs about control over gambling; and situational self-efficacy to avoid gambling.
Participants were encouraged to consider the feedback in light of their personal goals.
All participants received a copy of their feedback, a list of skills for limiting gambling and a resource/referral list.
|
Experimental: Cognitive Behavioral Intervention
See Intervention Description
|
Participants completed either six weekly 1-hour sessions or attend four sessions containing the same content.
Sessions covered functional analysis and gambling triggers; challenging cognitive distortions, with emphasis on illusions of control; coping with triggers; assertiveness; and relapse prevention.
Participants received a pamphlet covering each week's topic (which was reviewed with the participant if a session was missed), as well as homework sheets and gambling diaries.
CBI participants were asked to refrain from gambling for the duration of the group to provide an opportunity to practice and develop skills applicable to gambling and other behavior change situations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
South Oaks Gambling Screen (SOGS)
Time Frame: 6-Months
|
The 20-item South Oaks Gambling Screen (SOGS) measures gambling involvement and problem severity based on DSM-III-R pathological gambling criteria.
|
6-Months
|
Gambling Quantity and Perceived Norms Scale (GQPN)
Time Frame: 6 Months
|
The gambling quantity and perceived norms scale (GQPN) includes a six-item expenditure subscale assessing amount of money won/lost through gambling on a 10-point scale from $0 to more than $2000 over time-periods from the past month to past year.
Additional items assess gambling frequency (on a 10-point scale from never to every day in the past year), disposable income (on an 11-point scale from less than $50 to more than $500 per month) and perceptions of gambling frequency and expenditure for the typical college student (perceived norms).
Gambling expenditure was calculated as the expenditure subscale mean residualized on disposable income.
|
6 Months
|
Gambling Frequency (SOGS)
Time Frame: 6 Months
|
The SOGS was modified to assess internet gambling frequency and expand gambling frequency response options from a three- to a five-point scale with anchors of no times, one to 10 times, more than 10 times, less than weekly, weekly or more than weekly but less than daily, and daily.
This modified frequency scale has been shown to correlate highly with other measures of gambling frequency.
|
6 Months
|
Gambling Problems Index (GPI)
Time Frame: 6 Months
|
Gambling problems (or negative consequences) were assessed using the 20-item Gambling Problems Index (GPI).
Participants indicated how often, from never to more than 10 times in the past 6 months, they experienced consequences while, or as a result of, gambling.
|
6 Months
|
National Opinion Research Center DSM-IV Screen for Pathological Gambling (NODS)
Time Frame: 6 Months
|
DSM-IV [1] criteria for pathological gambling were assessed using the 17-item National Opinion Research Center DSM-IV Screen (NODS).
Some criteria have multiple items, but possible scores range from 0-10 DSM-IV criteria endorsed in the past 6 months.
|
6 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Illusions of Control
Time Frame: 6 Months
|
Illusions of control were assessed via a six-item subscale from the Beliefs About Control Scale (BACS), on a five-point scale ranging from strongly disagree to strongly agree.
|
6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mary E Larimer, Ph.D, University of Washington, Dept of Psychiatry & Behavioral Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Primary Completion (Actual)
July 1, 2003
Study Completion (Actual)
July 1, 2003
Study Registration Dates
First Submitted
February 20, 2004
First Submitted That Met QC Criteria
February 23, 2004
First Posted (Estimate)
February 24, 2004
Study Record Updates
Last Update Posted (Estimate)
December 11, 2013
Last Update Submitted That Met QC Criteria
December 10, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23848-C
- R21MH067026 (U.S. NIH Grant/Contract)
- DATR A2-AII
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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