NCT01643044

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 1, 2014

Completed
Last Updated

August 1, 2014

Status Verified

July 1, 2014

Enrollment Period

3.1 years

First QC Date

July 13, 2012

Results QC Date

July 7, 2014

Last Update Submit

July 7, 2014

Conditions

Alcohol Abuse

Keywords

pregnancyscreeningmotivation

Outcome Measures

Primary Outcomes (1)

  • Alcohol Use

    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.

    self-reported use during 90 days prior to delivery of their baby

Study Arms (2)

Alcohol intervention

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Behavioral: Nutrition time control/placebo intervention

Interventions

Nutrition time control/placebo interventionBEHAVIORAL

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.

Control
Computer-delivered, brief intervention on alcohol useBEHAVIORAL

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.

Alcohol intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Steven Ondersma, PhD
Organization
Wayne State University
sondersm@med.wayne.edu
313-444-9797

Study Officials

  • Steven J Ondersma, Ph.D.

    Wayne State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 13, 2012

First Posted

July 17, 2012

Study Start

April 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

August 1, 2014

Results First Posted

August 1, 2014

Record last verified: 2014-07

Locations

US(1)