Computer-delivered Screening and Brief Intervention for Alcohol Use in Pregnancy
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Alcohol Abuse |
Behavioral: Nutrition time control/placebo intervention Behavioral: Computer-delivered, brief intervention on alcohol use |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Screening |
| Official Title: | Computer-delivered SBIRT for Alcohol Use in Pregnancy: Planning a Stage II Trial |
- Alcohol use [ Time Frame: self-reported use during 120 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.
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders 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
Contacts and Locations| Contact: Jessica R Beatty, Ph.D. | 313-664-2518 | jbeatty@wayne.edu |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Principal Investigator: Steven J Ondersma, Ph.D. | |
| Principal Investigator: | Steven J Ondersma, Ph.D. | Wayne State University |
More Information
No publications provided
| Responsible Party: | Steven J. Ondersma, Associate Professor, Wayne State University |
| ClinicalTrials.gov Identifier: | NCT01643044 History of Changes |
| Other Study ID Numbers: | R34AA020056, R34AA020056 |
| Study First Received: | July 13, 2012 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Wayne State University:
|
pregnancy screening motivation |
Additional relevant MeSH terms:
|
Alcohol Drinking Alcoholism Drinking Behavior Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Ethanol |
Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013