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Brief Intervention in At-Risk First-time Mothers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University
ClinicalTrials.gov Identifier:
NCT00230009
First received: September 29, 2005
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Substance Use
Behavioral: Brief motivational intervention
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Brief Intervention in At-Risk First-time Mothers

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Alcohol Use [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The number of participants who reported seeking outpatient substance abuse treatment since baseline (either at a treatment facility or through outpatient counseling).


Secondary Outcome Measures:
  • Depression [ Time Frame: at 3 month follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: April 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Assessment only
Experimental: Brief intervention session Behavioral: Brief motivational intervention

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230009

Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48207
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Steven J Ondersma, Ph.D. Wayne State University