Computerized Brief Intervention vs. Delayed Computerized Brief Intervention

April 19, 2017 updated by: Friends Research Institute, Inc.
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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

    • New Mexico
      • Edgewood, New Mexico, United States, 87015
        • First Choice Community Healthcare

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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
Experimental: Computerized Brief Intervention
Computerized Brief Intervention is delivered using a talking, animated cartoon-like parrot that provides patient feedback, empathic reflection, and personalization regarding their drug use.
No additional information needed.
Other: Delayed Computerized Brief Intervention
Participants receive only a substance abuse assessment at baseline. At three-month follow-up, they then receive the computerized brief intervention.
No additional information needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score
Time Frame: 3 month follow-up
The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.
3 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score
Time Frame: 6-month follow-up
The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.
6-month follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids.
Time Frame: 3-month
Radioimmunoassay (RIA) Tests were used.
3-month
Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids
Time Frame: 6-month follow-up
Radioimmunoassay Testing (RIA) was conducted
6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert P Schwartz, M.D., Friends Research Institute, Inc.

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

August 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 6, 2013

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 1R01DA026003-B
  • 1R01DA026003 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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