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.

Study Overview

• Status: Completed
• Conditions: Substance Use
• Intervention / Treatment: Behavioral: Brief motivational intervention

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48207
      • Wayne State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Assessment only
Experimental: Brief intervention session	Behavioral: Brief motivational intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 month follow-up
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.	3 month follow-up
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).	baseline and 3 month follow-up
Treatment Engagement	The number of participants who reported seeking outpatient substance abuse treatment since baseline (either at a treatment facility or through outpatient counseling).	at 3 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at 3 month follow-up

Collaborators and Investigators

• Sponsor: Wayne State University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Steven J Ondersma, Ph.D., Wayne State University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: September 29, 2005
• First Submitted That Met QC Criteria: September 29, 2005
• First Posted (Estimate): September 30, 2005

Study Record Updates

• Last Update Posted (Estimate): August 8, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: child abuse, child neglect, substance use, violence exposure, brief intervention
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: NIDA-00516-3; K23DA000516 (U.S. NIH Grant/Contract)