NCT01961050

Brief Summary

The purpose of this study is to evaluate an intervention aimed at reducing risk for alcohol-exposed pregnancies and preventing Fetal Alcohol Spectrum Disorders in Russian children. The study will determine whether physicians, trained in a dual-focused brief motivational intervention and monitored for performance, can foster greater change in knowledge, health beliefs, alcohol use, and alcohol-exposed pregnancy risk in Russian women who are at risk than standard care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
767

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 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

Study Start

First participant enrolled

September 1, 2007

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

7.8 years

First QC Date

October 8, 2013

Last Update Submit

February 18, 2016

Conditions

Fetal Alcohol Syndrome (FAS)Fetal Alcohol Spectrum DisordersAlcohol Abuse in Pregnancy

Keywords

alcoholpregnancyfetal exposurepreventionFASAlcohol-Related Neurodevelopmental Disorder (ARND)

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 3 months

    Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.

    3 months

  • Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 6 months

    Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.

    6 months

  • Change from Baseline Alcohol-Exposed Pregnancy (AEP) risk at 12 months

    Interviews are conducted at the baseline and follow-up assessments at 3, 6, and 12 months after the baseline to assess self-reported alcohol consumption, sexual activity, and contraception use to identify AEP risk.

    12 months

Secondary Outcomes (3)

  • Changes in alcohol consumption from baseline

    3 months, 6 months, and 12 months follow-up

  • Changes in knowledge about Fetal Alcohol Syndrome (FAS) from baseline

    3 months, 6 months, and 12 months follow-up

  • Changes in Health beliefs and attitudes from baseline

    3 months, 6 months, and 12 months follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

Dual-Focused Brief Physician Intervention (DFBPI)

Behavioral: Dual-Focused Brief Physician Intervention (DFBPI)

Standard care

OTHER

Services as usual including standard OB/GYN clinic visits; no experimental intervention is provided.

Other: Services as usual

Interventions

Dual-Focused Brief Physician Intervention (DFBPI)BEHAVIORAL

The DFBPI is incorporated in OB/GYN clinic visit. The intervention consists of two brief (5 to 10 minutes) manualized counseling segments delivered face-to-face by an OB/GYN in the context of two clinic visits.

Intervention
Services as usualOTHER

Active Comparator: Standard OB/GYN clinic visits that include OB/GYN services as usual.

Standard care

Eligibility Criteria

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

You may qualify if:

  • nonpregnant women
  • childbearing age (between 18 and 44 years of age)
  • fertile
  • at risk for an alcohol-exposed pregnancy: drinking at-risk (4 or more drinks on one occasion or more than 7 drinks per week)in the last 3 months and report having unprotected intercourse at least once in the last 6 months

You may not qualify if:

  • unable comprehend interview questions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Women's Clinics

Nizhny Novgorod, 603950, Russia

Location

Women's clinics

Saint Peterburg, 199034, Russia

Location

Related Publications (1)

  • Balachova T, Bonner BL, Chaffin M, Isurina G, Shapkaitz V, Tsvetkova L, Volkova E, Grandilevskaya I, Skitnevskaya L, Knowlton N. Brief FASD prevention intervention: physicians' skills demonstrated in a clinical trial in Russia. Addict Sci Clin Pract. 2013 Jan 8;8(1):1. doi: 10.1186/1940-0640-8-1.

    PMID: 23294846RESULT

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Tatiana Balachova, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 11, 2013

Study Start

September 1, 2007

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations

RU(2)