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Brief Intervention in At-Risk First-time Mothers

Primary Purpose

Substance Use

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brief motivational intervention
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use focused on measuring child abuse, child neglect, substance use, violence exposure, brief intervention

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Assessment only

Brief intervention session

Arm Description

Outcomes

Primary Outcome Measures

Alcohol Use
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
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
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
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
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.

Full Information

First Posted
September 29, 2005
Last Updated
August 6, 2013
Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00230009
Brief Title
Brief Intervention in At-Risk First-time Mothers
Official Title
Brief Intervention in At-Risk First-time Mothers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
child abuse, child neglect, substance use, violence exposure, brief intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assessment only
Arm Type
No Intervention
Arm Title
Brief intervention session
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Brief motivational intervention
Primary Outcome Measure Information:
Title
Alcohol Use
Description
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.
Time Frame
3 month follow-up
Title
Drug Use
Description
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.
Time Frame
3 month follow-up
Title
Child Abuse Potential
Description
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).
Time Frame
baseline and 3 month follow-up
Title
Treatment Engagement
Description
The number of participants who reported seeking outpatient substance abuse treatment since baseline (either at a treatment facility or through outpatient counseling).
Time Frame
at 3 month follow-up
Secondary Outcome Measure Information:
Title
Depression
Description
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.
Time Frame
at 3 month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J Ondersma, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48207
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11876674
Citation
Delaney-Black V, Covington C, Ondersma SJ, Nordstrom-Klee B, Templin T, Ager J, Janisse J, Sokol RJ. Violence exposure, trauma, and IQ and/or reading deficits among urban children. Arch Pediatr Adolesc Med. 2002 Mar;156(3):280-5. doi: 10.1001/archpedi.156.3.280.
Results Reference
background
PubMed Identifier
15901230
Citation
Ondersma SJ, Chaffin MJ, Mullins SM, LeBreton JM. A brief form of the child abuse potential inventory: development and validation. J Clin Child Adolesc Psychol. 2005 Jun;34(2):301-11. doi: 10.1207/s15374424jccp3402_9. Erratum In: J Clin Child Adolesc Psychol. 2006 Dec;35(4):598.
Results Reference
background
PubMed Identifier
15611328
Citation
Mullins SM, Bard DE, Ondersma SJ. Comprehensive services for mothers of drug-exposed infants: relations between program participation and subsequent child protective services reports. Child Maltreat. 2005 Feb;10(1):72-81. doi: 10.1177/1077559504272101.
Results Reference
background
PubMed Identifier
15223094
Citation
Mullins SM, Suarez M, Ondersma SJ, Page MC. The impact of motivational interviewing on substance abuse treatment retention: a randomized control trial of women involved with child welfare. J Subst Abuse Treat. 2004 Jul;27(1):51-8. doi: 10.1016/j.jsat.2004.03.010.
Results Reference
background

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Brief Intervention in At-Risk First-time Mothers

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