Brief Intervention in At-Risk First-time Mothers

NCT00230009 | Completed Phase 1 Results

• 2 other identifiers: NIDA-00516-3K23DA000516
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use

Keywords

child abuse, child neglect, substance use, violence exposure, brief intervention

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Depression

  at 3 month follow-up

Study Arms (2)

Assessment only

NO INTERVENTION

Brief intervention session

EXPERIMENTAL

Behavioral: Brief motivational intervention

Interventions

Brief motivational intervention BEHAVIORAL

Brief intervention session

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Frank psychosis or other cognitive impairment

Sponsors & Collaborators

• Wayne State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48207, United States

Location

Related Publications (4)

• 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.

  PMID: 11876674 BACKGROUND

• 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.

  PMID: 15901230 BACKGROUND

• 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.

  PMID: 15611328 BACKGROUND

• 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.

  PMID: 15223094 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

This study is limited by the relatively small sample size and the restriction to low-income, urban women, thus limiting generalizability to other populations.

Results Point of Contact

• Title: Steven J. Ondersma, ,PI
• Organization: Wayne State University

s.ondersma@wayne.edu

313-577-6680

Study Officials

• Steven J Ondersma, Ph.D.

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 29, 2005
• First Posted: September 30, 2005
• Study Start: April 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: August 8, 2013
• Results First Posted: August 8, 2013

Record last verified: 2013-08

Locations

US (1)