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Completed

NCT Number: NCT00230009

Brief Intervention in At-Risk First-time Mothers

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.

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Key information

Conditions

Substance Use Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Wayne State University

Detroit, Michigan, 48207, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Pregnant, expecting first child

Inclusion criteria

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

Exclusion criteria

Frank psychosis or other cognitive impairment

Treatment and study plan

Brief Motivational Intervention

Behavioral

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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

  1. Depression

    Time frame: at 3 month follow-up

    Depression was measured by using the Center for Epidemiologic Studies Depression Scale (CES-D) at the 3 month follow-up. CES-D total scores can range from 0 to 60. Scores at 16 or higher indicate clinical significance. Higher scores represent higher risk for depression.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 30, 2005
Registry last updated
Aug 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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