Back to resultsPilot Clinical Trial of Computer-based Motivational Intervention - 1
Primary Purpose
Substance-Related Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brief computer-delivered intervention
Sponsored by
About this trial
This is an interventional treatment trial for Substance-Related Disorders
Eligibility Criteria
Woman in immediate post-partum period Inclusion Criteria: Self-report of drug use prior to pregnancy Exclusion Criteria: Frank psychosis or other cognitive impairment; inability to communicate in English; fatigue; recent receipt of narcotic pain medication; grieving over medically compromised infant
Sites / Locations
- Wayne State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Brief computer-delivered intervention
Assessment only
Arm Description
A 20-minute interaction with software designed to partially replicate the experience of a brief motivational intervention with a therapist or health care professional. Included decisional balance, normed feedback, and optional goal-setting.
Participants in this arm only completed assessment section, same as intervention group, but then was done.
Outcomes
Primary Outcome Measures
Motivation to Change Substance Use
An eight-item measure tapping motivation to change, self-efficacy, and change intention was assessed using visual analog scales. The average of the eight items was calculated resulting in a score ranging from 1 to 100. The measure was asked at baseline (reported in baseline data) and the one month follow-up. Scores here represent average level of motivation for change at the time of follow-up. Higher scores represent higher levels of motivation to change, self-efficacy and intention to change.
Secondary Outcome Measures
Full Information
NCT ID
NCT00230022
First Posted
September 29, 2005
Last Updated
June 10, 2013
Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00230022
Brief Title
Pilot Clinical Trial of Computer-based Motivational Intervention - 1
Official Title
Pilot Clinical Trial of Computer-based Motivational Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pilot trial of computer-based motivational intervention. Hypothesis: The brief computer-delivered intervention would result in higher motivation to change at follow-up.
Detailed Description
Participants were randomized into brief intervention vs. assessment-only conditions, with follow-up to measure overall motivation to change.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief computer-delivered intervention
Arm Type
Experimental
Arm Description
A 20-minute interaction with software designed to partially replicate the experience of a brief motivational intervention with a therapist or health care professional. Included decisional balance, normed feedback, and optional goal-setting.
Arm Title
Assessment only
Arm Type
No Intervention
Arm Description
Participants in this arm only completed assessment section, same as intervention group, but then was done.
Intervention Type
Behavioral
Intervention Name(s)
Brief computer-delivered intervention
Intervention Description
20-minute interaction with voice-enabled software that could provide reflections, images, text, etc.
Primary Outcome Measure Information:
Title
Motivation to Change Substance Use
Description
An eight-item measure tapping motivation to change, self-efficacy, and change intention was assessed using visual analog scales. The average of the eight items was calculated resulting in a score ranging from 1 to 100. The measure was asked at baseline (reported in baseline data) and the one month follow-up. Scores here represent average level of motivation for change at the time of follow-up. Higher scores represent higher levels of motivation to change, self-efficacy and intention to change.
Time Frame
One month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Woman in immediate post-partum period
Inclusion Criteria:
Self-report of drug use prior to pregnancy
Exclusion Criteria:
Frank psychosis or other cognitive impairment; inability to communicate in English; fatigue; recent receipt of narcotic pain medication; grieving over medically compromised infant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Ondersma, Ph.D.
Organizational Affiliation
ACT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48207
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15925264
Citation
Ondersma SJ, Chase SK, Svikis DS, Schuster CR. Computer-based brief motivational intervention for perinatal drug use. J Subst Abuse Treat. 2005 Jun;28(4):305-12. doi: 10.1016/j.jsat.2005.02.004.
Results Reference
result
Learn more about this trial
Pilot Clinical Trial of Computer-based Motivational Intervention - 1
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