Healthy Moms Alcohol Intervention

NCT ID: NCT00244062

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2007-06-30

Brief Summary

The study proposes to test the efficacy of a primary care-based brief intervention with women who resumed heavy drinking during the post-partum period and who used alcohol during a previous pregnancy. The trial will also examine the effects of tobacco use, illicit drug use, depression and domestic violence on alcohol use.

Conditions

Fetal Alcohol Syndrome; Pregnancy; Alcoholism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Interventions

counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Women of childbearing age (18-40) who drank alcohol during their previous pregnancy and who report drinking above recommended limits in the post partum period.

Exclusion Criteria

• N/A

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Fleming, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Other Identifiers

5R01AA012522-03

Identifier Type: NIH

Identifier Source: secondary_id

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5R01AA012522-03

Identifier Type: NIH

Identifier Source: org_study_id

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