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Screening Brief Intervention Referral to Treatment (SBIRT) in New Mexico

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ClinicalTrials.gov Identifier: NCT01131520
Recruitment Status : Completed
First Posted : May 27, 2010
Results First Posted : August 21, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Friends Research Institute, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Drug Abuse
HIV Risk Behavior
Interventions Behavioral: Computerized brief intervention
Behavioral: Counselor delivered brief intervention
Enrollment 360

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Computerized Brief Intervention Counselor Delivered Brief Intervention
Hide Arm/Group Description

Computerized one-session brief intervention for drug use

Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.

Period Title: Overall Study
Started 180 180
Completed 179 176
Not Completed 1 4
Reason Not Completed
Computer problem             1             0
Counselor not available             0             3
Subject changed history after enrollment             0             1
Arm/Group Title Computerized Brief Intervention Counselor Delivered Brief Intervention Total
Hide Arm/Group Description

Computerized one-session brief intervention for drug use

Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.

Total of all reporting groups
Overall Number of Baseline Participants 180 179 359
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 180 participants 179 participants 359 participants
36.5  (14.7) 35.7  (14.6) 36.1  (14.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 179 participants 359 participants
Female
83
  46.1%
82
  45.8%
165
  46.0%
Male
97
  53.9%
97
  54.2%
194
  54.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 179 participants 359 participants
Hispanic or Latino
83
  46.1%
85
  47.5%
168
  46.8%
Not Hispanic or Latino
97
  53.9%
94
  52.5%
191
  53.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 179 participants 359 participants
American Indian or Alaska Native
6
   3.3%
6
   3.4%
12
   3.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   0.6%
2
   1.1%
3
   0.8%
Black or African American
3
   1.7%
1
   0.6%
4
   1.1%
White
162
  90.0%
161
  89.9%
323
  90.0%
More than one race
8
   4.4%
9
   5.0%
17
   4.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 180 participants 179 participants 359 participants
180
 100.0%
179
 100.0%
359
 100.0%
1.Primary Outcome
Title Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
Hide Description The ASSIST's Global Continuum of Illicit Drug Risk was used. A higher score is considered more severe risk. The scores range from 0 to 308.
Time Frame 3 months post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Computerized Brief Intervention Counselor Delivered Brief Intervention
Hide Arm/Group Description:

Computerized one-session brief intervention for drug use

Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.

Overall Number of Participants Analyzed 180 179
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
27.8  (0.93) 29.6  (0.93)
2.Primary Outcome
Title Hair Testing
Hide Description The number of participants testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC)
Time Frame 3 month post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants of the total sample who agreed to provide an analyzable hair specimen. Hair testing was not available for subjects not interviewed, those who refused testing, or who were unable to provide a sufficient quantity of hair for testing.
Arm/Group Title Computerized Brief Intervention Counselor Delivered Brief Intervention
Hide Arm/Group Description:

Computerized one-session brief intervention for drug use

Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.

Overall Number of Participants Analyzed 159 155
Measure Type: Count of Participants
Unit of Measure: Participants
93
  58.5%
100
  64.5%
3.Secondary Outcome
Title Human Immunodeficiency Virus (HIV) Drug Use Risk Assessment Battery Subscale
Hide Description HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Time Frame 3 months post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Computerized Brief Intervention Counselor Delivered Brief Intervention
Hide Arm/Group Description:

Computerized one-session brief intervention for drug use

Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.

Overall Number of Participants Analyzed 180 179
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
.06  (.03) .01  (.03)
4.Secondary Outcome
Title Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
Hide Description ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.
Time Frame 6 month post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Computerized Brief Intervention Counselor Delivered Brief Intervention
Hide Arm/Group Description:

Computerized one-session brief intervention for drug use

Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.

Overall Number of Participants Analyzed 180 179
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
27.3  (1.30) 27.4  (1.33)
5.Secondary Outcome
Title Alcohol, Smoking & Substance Involvement Screening Test (ASSIST) Score
Hide Description ASSIST's Global Continuum of Illicit Drug Risk Score which ranges from 0 to 308. A higher score is associated with higher risk.
Time Frame 12 months post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Computerized Brief Intervention Counselor Delivered Brief Intervention
Hide Arm/Group Description:

Computerized one-session brief intervention for drug use

Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.

Overall Number of Participants Analyzed 180 179
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
26.5  (1.32) 25.9  (1.34)
6.Secondary Outcome
Title Hair Testing
Hide Description The predicted probabilities for testing positive on Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and tetrahydrocannabinol (THC), calculated from generalized estimating equations.
Time Frame 6 month post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The sample includes participants who provided usable hair testing data at baseline.
Arm/Group Title Computerized Brief Intervention Counselor Delivered Brief Intervention
Hide Arm/Group Description:

Computerized one-session brief intervention for drug use

Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.

Overall Number of Participants Analyzed 159 155
Least Squares Mean (Standard Error)
Unit of Measure: predicted probability of positive test
.59  (.04) .67  (.04)
7.Secondary Outcome
Title Hair Testing
Hide Description Predicted Probabilities for testing positive on the Radioimmunoassay (RIA) Hair Testing for opiates, cocaine, amphetamine and THC, calculated from generalized estimating equations.
Time Frame 12 month post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The sample includes participants who provided usable hair testing data at baseline
Arm/Group Title Computerized Brief Intervention Counselor Delivered Brief Intervention
Hide Arm/Group Description:

Computerized one-session brief intervention for drug use

Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.

Overall Number of Participants Analyzed 159 155
Least Squares Mean (Standard Error)
Unit of Measure: predicted probability of positive test
.57  (.04) .59  (.04)
8.Secondary Outcome
Title Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale
Hide Description HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Time Frame 6 month post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Computerized Brief Intervention Counselor Delivered Brief Intervention
Hide Arm/Group Description:

Computerized one-session brief intervention for drug use

Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.

Overall Number of Participants Analyzed 180 179
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
.02  (.03) .04  (.03)
9.Secondary Outcome
Title Human Immunodeficiency Virus (HIV) Risk Assessment Battery Subscale Score
Hide Description HIV Drug Use Risk Assessment Battery Subscale Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Time Frame 12 month post-baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Computerized Brief Intervention Counselor Delivered Brief Intervention
Hide Arm/Group Description:

Computerized one-session brief intervention for drug use

Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.

Overall Number of Participants Analyzed 180 179
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
.05  (.03) .01  (.04)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Computerized Brief Intervention Counselor Delivered Brief Intervention
Hide Arm/Group Description

Computerized one-session brief intervention for drug use

Computerized brief intervention: This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.

This is a brief intervention focused on drug use delivered by a behavioral health counselor and based on motivational interviewing

Counselor delivered brief intervention: This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.

All-Cause Mortality
Computerized Brief Intervention Counselor Delivered Brief Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Computerized Brief Intervention Counselor Delivered Brief Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/180 (0.00%)   0/179 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Computerized Brief Intervention Counselor Delivered Brief Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/180 (0.00%)   0/179 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Robert Schwartz
Organization: Friends Research Institute
Phone: 410-837-3977
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01131520     History of Changes
Other Study ID Numbers: 08-08-173
R01DA026003 ( U.S. NIH Grant/Contract )
First Submitted: May 21, 2010
First Posted: May 27, 2010
Results First Submitted: December 20, 2016
Results First Posted: August 21, 2017
Last Update Posted: December 12, 2017