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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Wayne State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University
ClinicalTrials.gov Identifier:
NCT01643044
First received: July 13, 2012
Last updated: February 12, 2014
Last verified: February 2014

July 13, 2012
February 12, 2014
April 2011
March 2014   (final data collection date for primary outcome measure)
Alcohol use [ Time Frame: self-reported use during 90 days prior to delivery of their baby ] [ Designated as safety issue: No ]
Alcohol use will be measured at the time of delivery of their infant by self-report and urine analysis.
Alcohol use [ Time Frame: post-partum follow-up ] [ Designated as safety issue: No ]
Alcohol use will be measured at the time of delivery of their infant by self-report and urine analysis.
Complete list of historical versions of study NCT01643044 on ClinicalTrials.gov Archive Site
Not Provided
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Computer-delivered Screening and Brief Intervention for Alcohol Use in Pregnancy
Computer-delivered SBIRT for Alcohol Use in Pregnancy: Planning a Stage II Trial

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Screening
Alcohol Abuse
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Computer-delivered, brief intervention on alcohol use
  • Placebo Comparator: Control
    Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
    Intervention: Behavioral: Nutrition time control/placebo intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
No
Contact: Jessica R Beatty, Ph.D. 313-664-2518 jbeatty@wayne.edu
United States
 
NCT01643044
R34AA020056, R34AA020056
No
Steven J. Ondersma, Wayne State University
Wayne State University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Steven J Ondersma, Ph.D. Wayne State University
Wayne State University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP