Interactive Motivational Media for Perinatal Drug Abuse - 3

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University
ClinicalTrials.gov Identifier:
NCT00230048
First received: September 29, 2005
Last updated: October 29, 2012
Last verified: October 2012
Results First Received: October 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   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
Assessment Only This arm answered questions only, but received no intervention.
Brief Intervention Brief computer-delivered intervention following motivational approach, adapted from Motivational Interviewing: Decisional balance, normed feedback, and optional goal-setting.

Participant Flow:   Overall Study
    Assessment Only     Brief Intervention  
STARTED     52     55  
Completed Intervention/Control Session     52     55  
COMPLETED     39     37  
NOT COMPLETED     13     18  
Lost to Follow-up                 13                 18  



  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
Assessment Only This arm answered questions only, but received no intervention.
Brief Intervention Brief computer-delivered intervention following 5As/5Rs approach.
Total Total of all reporting groups

Baseline Measures
    Assessment Only     Brief Intervention     Total  
Number of Participants  
[units: participants]
  52     55     107  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     52     55     107  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  24.2  ± 5.4     25.9  ± 5.7     25.1  ± 5.6  
Gender  
[units: participants]
     
Female     52     55     107  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     52     55     107  



  Outcome Measures
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1.  Primary:   Number of Participants With Drug Use at 3 Months   [ Time Frame: 3 months ]

2.  Primary:   Treatment Engagement   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Generalizability limited by relatively small sample, attrition of 29%, and restriction to low-income mothers. Second, power limitations prevented verification of effects on the dichotomous outcomes, despite effects in the small-moderate range.


  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.


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: NCT00230048     History of Changes
Other Study ID Numbers: NIDA-14621-3, R21DA014621
Study First Received: September 29, 2005
Results First Received: October 12, 2011
Last Updated: October 29, 2012
Health Authority: United States: Federal Government