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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01643044
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : August 1, 2014
Last Update Posted : August 1, 2014
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University

Brief Summary:

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:

  1. Evaluation of the usefulness of handheld devices and anonymous screening for self report of at-risk alcohol use among pregnant women.
  2. Assessing the validity of an alcohol biomarker, Ethyl Glucoronide (EtG), for the detection of at-risk drinking in pregnant women.
  3. 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

Detailed Description:
Infants born to African-American and/or low SES women appear to be at increased risk of adverse effects due to prenatal exposure to alcohol. Computer-delivered SBIRT approaches may provide consistent screening and evidence-based brief interventions, at low cost, without requiring substantial investments of time or energy from medical staff. However, several Stage I steps are necessary before moving to a Stage II clinical trial. This R34 application will therefore lay the groundwork for a fully powered clinical trial of a computer-delivered SBIRT for alcohol use during pregnancy. It will do so through the conduct of five key preliminary studies, including: (1) evaluation of the utility of handheld mobile devices and an anonymous self-interview format in screening for at-risk drinking among patients attending a prenatal clinic; (2) modification of an existing computer-delivered motivational intervention for alcohol use during pregnancy, to previously set standards of acceptability (to experts as well as representative pregnant women); (3) development of an evidence-based tailored messaging supplement to the single-session brief intervention; (4) examining the validity of, and cut scores for, the biomarker Ethyl Glucoronide (EtG) in pregnant women; and (5) collecting data on the acceptability, feasibility, and estimated effect size of the modified computer-delivered intervention through an N = 50 Phase I randomized clinical trial. Participants in this trial will be a diverse sample of women at-risk for alcohol use during pregnancy, the majority of whom will be African-American and/or low SES. These key preparatory steps will greatly facilitate the subsequent development of an R01 application to conduct a Stage II clinical trial for alcohol use during pregnancy. These steps will also provide important preliminary data on (a) a novel method for risk factor screening in primary care; (b) the potential utility of EtG as a biomarker for alcohol use during pregnancy and in the perinatal period; and (c) the effect size estimate for a fully computer-delivered, combined brief interactive/tailored messaging intervention requiring only a single contact. If successful, this line of research could lead to a highly cost-effective, high-reach intervention for alcohol use during pregnancy; these reductions in alcohol use could in turn have a meaningful population impact on Fetal Alcohol Spectrum Disorders.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older
  • intention to carry pregnancy to term
  • self-reported alcohol use
  • willingness to be sent tailored messages
  • gives consent to access medical records for collection of birth outcome data

Exclusion Criteria:

  • unable to communicate in English
  • less than 4 months before delivery due date

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01643044

United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Wayne State University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Steven J Ondersma, Ph.D. Wayne State University

Responsible Party: Steven J. Ondersma, Associate Professor, Wayne State University Identifier: NCT01643044     History of Changes
Other Study ID Numbers: R34AA020056 ( U.S. NIH Grant/Contract )
R34AA020056 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2012    Key Record Dates
Results First Posted: August 1, 2014
Last Update Posted: August 1, 2014
Last Verified: July 2014

Keywords provided by Steven J. Ondersma, Wayne State University:

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs