Back to resultsComputerized Brief Intervention vs. Delayed Computerized Brief Intervention
Primary Purpose
Drug Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Brief Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Drug Abuse focused on measuring brief intervention, computerized brief intervention
Eligibility Criteria
Inclusion Criteria:
- (1) minimum 18 years of age
- (2) primary care or dental patients at the participating clinics
- (3) score between 4 and 26 (moderate-risk) for illicit drug and/or nonmedical use of prescription drugs on any of the single item drug use risk scores of the ASSIST.
Exclusion Criteria:
- (1) score in the high-risk range on the ASSIST for any drug (except tobacco) or alcohol use (i.e., ASSIST score > 26)
- (2) no reported drug use within the past 3 months
- (3) drug abuse treatment within the past 12 months
- (4) a BI at the clinic with the behavioral health counselor within the past month
- (5) prior enrollment in the parent study;
- (6) plans to move out of New Mexico in the next 6 months
Sites / Locations
- First Choice Community Healthcare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Computerized Brief Intervention
Delayed Computerized Brief Intervention
Arm Description
Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.
Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.
Outcomes
Primary Outcome Measures
Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score
The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.
Secondary Outcome Measures
Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score
The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.
Full Information
NCT ID
NCT01936623
First Posted
September 3, 2013
Last Updated
April 19, 2017
Sponsor
Friends Research Institute, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01936623
Brief Title
Computerized Brief Intervention vs. Delayed Computerized Brief Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine whether a computerized brief intervention for moderate risk drug use among adult primary care patients is more effective than providing such patients with a substance abuse assessment alone.
Detailed Description
The study will enroll 80 adult primary care patients who have moderate risk drug use. Eligible participants (N = 80) will be randomly assigned to immediately receive a computerized brief intervention focused on drug use or to receive the same computerized brief intervention at 3-month follow-up. All participants will be assessed at three time points: baseline, and at 3 and 6 month follow-ups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse
Keywords
brief intervention, computerized brief intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computerized Brief Intervention
Arm Type
Experimental
Arm Description
Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.
Arm Title
Delayed Computerized Brief Intervention
Arm Type
Other
Arm Description
Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Brief Intervention
Intervention Description
No additional information needed.
Primary Outcome Measure Information:
Title
Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score
Description
The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.
Time Frame
3 month follow-up
Secondary Outcome Measure Information:
Title
Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score
Description
The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.
Time Frame
6-month follow-up
Other Pre-specified Outcome Measures:
Title
Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids.
Description
Radioimmunoassay (RIA) Tests were used.
Time Frame
3-month
Title
Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids
Description
Radioimmunoassay Testing (RIA) was conducted
Time Frame
6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
(1) minimum 18 years of age
(2) primary care or dental patients at the participating clinics
(3) score between 4 and 26 (moderate-risk) for illicit drug and/or nonmedical use of prescription drugs on any of the single item drug use risk scores of the ASSIST.
Exclusion Criteria:
(1) score in the high-risk range on the ASSIST for any drug (except tobacco) or alcohol use (i.e., ASSIST score > 26)
(2) no reported drug use within the past 3 months
(3) drug abuse treatment within the past 12 months
(4) a BI at the clinic with the behavioral health counselor within the past month
(5) prior enrollment in the parent study;
(6) plans to move out of New Mexico in the next 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Schwartz, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Choice Community Healthcare
City
Edgewood
State/Province
New Mexico
ZIP/Postal Code
87015
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Computerized Brief Intervention vs. Delayed Computerized Brief Intervention
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