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Clinical Trials/NCT00230009
NCT00230009
Completed
Phase 1

Brief Intervention in At-Risk First-time Mothers

Wayne State University1 site in 1 country100 target enrollmentApril 2004
ConditionsSubstance Use

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Substance Use
Sponsor
Wayne State University
Enrollment
100
Locations
1
Primary Endpoint
Alcohol Use
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Preliminary controlled trial of a brief intervention designed to reduce child maltreatment risk among low-income pregnant mothers. Foci will include major risk factors for maltreatment, including substance abuse, social isolation, depression, violence exposure, and maladaptive child-rearing attitudes/beliefs.

Registry
clinicaltrials.gov
Start Date
April 2004
End Date
March 2007
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steven J. Ondersma

Associate Professor

Wayne State University

Eligibility Criteria

Inclusion Criteria

  • Receipt of public assistance (e.g., Medicaid, Food Stamps), ability to communicate in English

Exclusion Criteria

  • Frank psychosis or other cognitive impairment

Outcomes

Primary Outcomes

Alcohol Use

Time Frame: 3 month follow-up

Alcohol use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported at the 3 month follow-up. The mean of each the control and intervention group was used. Frequency of use ranged from 0 to 5 for the follow-up sample. Higher scores mean more frequent use of the substance.

Drug Use

Time Frame: 3 month follow-up

Drug use was measured by looking at frequency of use in past 30 days with the Alcohol Use Disorders Identification Test (AUDIT), reported about marijuana use at the 3 month follow-up. The mean of each the assessment only and intervention group was used. Scores ranged from 0 to 13 for the follow-up sample. Higher scores mean more frequent use of the substance.

Child Abuse Potential

Time Frame: baseline and 3 month follow-up

Change score was calculated by taking the follow-up scores on the Brief Child Abuse Potential Inventory (BCAP) and subtracting the baseline score. The possible total score for the BCAP ranges from 0 to 24. Therefore, the possible range of scores for the change calculation (reported below) is -24 to +24. Higher scores indicate higher risk at the follow-up visit (worse outcome).

Treatment Engagement

Time Frame: at 3 month follow-up

The number of participants who reported seeking outpatient substance abuse treatment since baseline (either at a treatment facility or through outpatient counseling).

Secondary Outcomes

  • Depression(at 3 month follow-up)

Study Sites (1)

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