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Computer-delivered Screening and Brief Intervention for Alcohol Use in Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University
ClinicalTrials.gov Identifier:
NCT01643044
First received: July 13, 2012
Last updated: July 7, 2014
Last verified: July 2014
Results First Received: July 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Screening
Condition: Alcohol Abuse
Interventions: Behavioral: Nutrition time control/placebo intervention
Behavioral: Computer-delivered, brief intervention on alcohol use

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Alcohol Intervention

Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.

Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant.

Control

Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.

Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos.


Participant Flow:   Overall Study
    Alcohol Intervention     Control  
STARTED     24     24  
COMPLETED     20     19  
NOT COMPLETED     4     5  
Lost to Follow-up                 1                 1  
Miscarried baby                 2                 2  
Delivered outside of hospital                 1                 2  



  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
Alcohol Intervention

Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.

Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant.

Control

Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.

Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos.

Total Total of all reporting groups

Baseline Measures
    Alcohol Intervention     Control     Total  
Number of Participants  
[units: participants]
  24     24     48  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     24     24     48  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     24     24     48  
Male     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     18     21     39  
White     3     2     5  
More than one race     1     0     1  
Unknown or Not Reported     2     0     2  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     0     1  
Not Hispanic or Latino     23     24     47  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     24     24     48  



  Outcome Measures

1.  Primary:   Alcohol Use   [ Time Frame: self-reported use during 90 days prior to delivery of their baby ]


  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
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  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 Ondersma, PhD
Organization: Wayne State University
phone: 313-444-9797
e-mail: sondersm@med.wayne.edu


No publications provided


Responsible Party: Steven J. Ondersma, Wayne State University
ClinicalTrials.gov Identifier: NCT01643044     History of Changes
Other Study ID Numbers: R34AA020056, R34AA020056
Study First Received: July 13, 2012
Results First Received: July 7, 2014
Last Updated: July 7, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board