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Interactive Motivational Media for Perinatal Drug Abuse - 3

NCT ID: NCT00230048

Last Updated: 2012-10-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2006-02-28

Brief Summary

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Interactive Motivational Media for Perinatal Drug Abuse

Detailed Description

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The goal of this exploratory/developmental proposal is to develop a low-cost, highly adaptable brief motivational intervention for perinatal drug abuse via embedding motivational principles in a self-contained interactive computer system. The Motivation Enhancement System (MES) will utilize a touch-screen, audio enhancement, and an interactive narrator to guide women in the immediate post-partum period through evaluation (thus facilitating self-report) and a one-time motivational intervention. A taxi voucher will be provided to further facilitate entry into treatment, and multiple tailored self-help mailings will be issued following discharge. If validated, this intervention could offer a highly cost-effective, replicable, and prescriptive method for increasing self-change and treatment involvement in drug abusers. Following development of the MES, a preliminary pilot phase will study the use of the MES with post-partum drug-using women and make necessary modifications, using data from participant debriefings and a single-case research design. After optimization of the MES, a clinical trial will randomly assign 120 post-partum drug-using women into treatment or assessment only conditions, with a 3-month blinded follow up to evaluate intervention effects on drug use and treatment involvement. Toxicological and self-report measures, as well as objective analysis of infant development, will be utilized. Participants will be lower socioeconomic status urban women.

Conditions

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Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Assessment only

Group Type NO_INTERVENTION

No interventions assigned to this group

Brief intervention

Group Type EXPERIMENTAL

Brief computer-delivered intervention

Intervention Type BEHAVIORAL

Brief (20-minute) computer delivered intervention, plus two subsequent non-tailored mailings.

Interventions

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Brief computer-delivered intervention

Brief (20-minute) computer delivered intervention, plus two subsequent non-tailored mailings.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Screen positive for drug use (self-report)

Exclusion Criteria

Frank psychosis or other cognitive impairment, fatigue, grief over medically compromised infant, inability to communicate in English
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Wayne State University

OTHER

Sponsor Role lead

Responsible Party

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Steven J. Ondersma

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven J Ondersma, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

ACT

Locations

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Wayne State University

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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Ondersma SJ, Chase SK, Svikis DS, Schuster CR. Computer-based brief motivational intervention for perinatal drug use. J Subst Abuse Treat. 2005 Jun;28(4):305-12. doi: 10.1016/j.jsat.2005.02.004.

Reference Type RESULT
PMID: 15925264 (View on PubMed)

Ondersma SJ, Svikis DS, Schuster CR. Computer-based brief intervention a randomized trial with postpartum women. Am J Prev Med. 2007 Mar;32(3):231-8. doi: 10.1016/j.amepre.2006.11.003. Epub 2007 Jan 22.

Reference Type RESULT
PMID: 17236741 (View on PubMed)

Other Identifiers

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R21DA014621

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDA-14621-3

Identifier Type: -

Identifier Source: org_study_id