Computer-delivered Screening and Brief Intervention for Alcohol Use in Pregnancy
|ClinicalTrials.gov Identifier: NCT01643044|
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : August 1, 2014
Last Update Posted : August 1, 2014
The purpose of this study is to lay the ground work for a fully powered clinical trial of a computer-delivered screener and intervention for alcohol use during pregnancy. The pilot study will include:
- Evaluation of the usefulness of handheld devices and anonymous screening for self report of at-risk alcohol use among pregnant women.
- Assessing the validity of an alcohol biomarker, Ethyl Glucoronide (EtG), for the detection of at-risk drinking in pregnant women.
- Evaluation of the efficacy of a computer-delivered brief intervention and use of tailored handouts to supplement the computer-based brief intervention focusing on alcohol use during pregnancy.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Abuse||Behavioral: Nutrition time control/placebo intervention Behavioral: Computer-delivered, brief intervention on alcohol use||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Computer-delivered SBIRT for Alcohol Use in Pregnancy: Planning a Stage II Trial|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Experimental: 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.
Behavioral: 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.
Placebo Comparator: Control
Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
Behavioral: 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.
- Alcohol Use [ Time Frame: self-reported use during 90 days prior to delivery of their baby ]Alcohol use will be measured at the time of delivery of their infant by self-report and urine analysis. The number represents the number of participants who were abstinent (reported no alcohol use and had a negative toxicology urine screen) from alcohol for the past 90 days.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643044
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Steven J Ondersma, Ph.D.||Wayne State University|