Pilot Clinical Trial of Computer-based Motivational Intervention - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University
ClinicalTrials.gov Identifier:
NCT00230022
First received: September 29, 2005
Last updated: June 10, 2013
Last verified: June 2013
Results First Received: October 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Substance-Related Disorders
Intervention: Behavioral: Brief computer-delivered intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Brief Computer-delivered Motivational Intervention Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
Assessment Only Only assessment, same as completed by intervention group. No further interaction with computer.

Participant Flow:   Overall Study
    Brief Computer-delivered Motivational Intervention     Assessment Only  
STARTED     15     15  
COMPLETED     15     15  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Brief Computer-delivered Motivational Intervention Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
Assessment Only Only assessment, same as completed by intervention group. No further interaction with computer.
Total Total of all reporting groups

Baseline Measures
    Brief Computer-delivered Motivational Intervention     Assessment Only     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     15     30  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     15     15     30  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     15     15     30  
Baseline motivation [1]
[units: units on a scale]
Mean ± Standard Deviation
  82.5  ± 18.9     79.5  ± 21.2     81.0  ± 20.3  
[1] Visual analog scale questions were used to assess baseline motivation, self-efficacy, problem recognition, and change likelihood. The average of the items were calculated for baseline measurement resulting in a score ranging from 1 to 100. Higher scores represent increase motivation for change, self-efficacy, problem recognition and increased likelihood of making a change.



  Outcome Measures

1.  Primary:   Motivation to Change Substance Use   [ Time Frame: One month ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size in the pilot clinical trial. Because of this lack of power, a statistically significant difference between groups was not demonstrated, and the 95% Confidence Interval (CI) for the effect size estimate included zero.  


Results Point of Contact:  
Name/Title: Steven J. Ondersma
Organization: Wayne State University
phone: 313-577-6680
e-mail: s.ondersma@wayne.edu


Publications of Results:

Responsible Party: Steven J. Ondersma, Wayne State University
ClinicalTrials.gov Identifier: NCT00230022     History of Changes
Other Study ID Numbers: NIDA-14621-1, R21DA014621
Study First Received: September 29, 2005
Results First Received: October 12, 2011
Last Updated: June 10, 2013
Health Authority: United States: Federal Government