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
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