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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
225

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Assessment Only Control
Completed Baseline and 6 month follow-up surveys only.
Experimental: Personalized Feedback Intervention
See Intervention Description
Behavioral: Personalized Feedback Intervention
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
Behavioral: Cognitive Behavioral Intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23848-C
  • R21MH067026 (U.S. NIH Grant/Contract)
  • DATR A2-AII

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