NCT02337361

Brief Summary

An innovative, self-administered computerized screening and brief intervention (SBI) for drinking during pregnancy will be adapted for use with non-pregnant childbearing age women and its efficacy will be tested in a small trial. Study findings will inform a larger randomized control trial for a primary prevention tool with the potential for broad health impact.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

October 21, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 22, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
5 months until next milestone

Results Posted

Study results publicly available

January 23, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

October 21, 2014

Results QC Date

December 17, 2018

Last Update Submit

January 23, 2019

Conditions

Foetal Exposure During Pregnancy

Keywords

risky alcohol usepregnancy

Outcome Measures

Primary Outcomes (3)

  • Number of Participants Reporting Risky Alcohol Use

    Risky alcohol use is defined as drinking 8 or more drinks in a week or 3 or more drinks in a day. Risky alcohol use is measured by frequency of any alcohol use, number of usual and maximum drinks in a drinking day, and frequency of drinking 3 or more drinks containing alcohol

    baseline, 3 months, 6 months

  • Number of Participants Reporting Weekly Alcohol Use

    weekly alcohol use is defined as at least drinking once a week or more often

    baseline, 3 month, 6 month

  • Number of Participants Reporting Heavy Alcohol Use

    heavy alcohol use is defined as self-reported maximum number of drinks in a day of 5 or more drinks

    baseline, 3 month, 6 month

Secondary Outcomes (4)

  • Number of Participants Reporting Any Tobacco Use

    baseline , 3 months, 6 months

  • Number of Participants Reporting Frequent Sugar Sweetened Beverage Use

    baseline, 3 months, 6 months

  • Number of Participants Reporting Significant Depression

    baseline, 3 months, 6 months

  • Number of Participants Reporting Any Drug Use

    baseline, 3 month, 6 month

Study Arms (2)

e-SBI

EXPERIMENTAL

Single session, Electronic SBI for risky alcohol use

Behavioral: Electronic SBI

Control

NO INTERVENTION

Treatment as usual with only assessment

Interventions

Electronic SBIBEHAVIORAL

Bilingual (English and Spanish) e-SBI with four key components: 1\) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies.

e-SBI

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • not pregnant in the last 6 months, drank alcohol in the past year, alcohol consumption was at risky levels,

You may not qualify if:

  • not fluent in english or spanish,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

La Clinica Women Infants and Children Program Site

Oakland, California, 94601, United States

Location

Sonoma County Department of Health Services

Santa Rosa, California, 95403, United States

Location

Related Publications (1)

  • Nayak MB, Kaskutas LA, Mericle AA. Randomized Trial of an Innovative Electronic Screening and Brief Intervention for Reducing Drinking Among Women of Childbearing Age. J Addict Med. 2019 Nov/Dec;13(6):450-459. doi: 10.1097/ADM.0000000000000518.

    PMID: 30882553DERIVED

Limitations and Caveats

Participants in the e-SBI group were re-administered the brief intervention at 3-month follow-up if they reported any alcohol use at that follow-up.

Results Point of Contact

Title
Madhabika B. Nayak
Organization
Public Health Institute/Alcohol Research Group
mnayak@arg.org
510-898-5849

Study Officials

  • Madhabika Nayak, Ph.D.

    Public Health Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2014

First Posted

January 13, 2015

Study Start

February 22, 2016

Primary Completion

August 31, 2017

Study Completion

August 31, 2018

Last Updated

January 25, 2019

Results First Posted

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)