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Completed

NCT Number: NCT00230048

Interactive Motivational Media for Perinatal Drug Abuse - 3

Interactive Motivational Media for Perinatal Drug Abuse

Completed

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Wayne State University

Detroit, Michigan, 48207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Woman in immediate postpartum period

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

Treatment and study plan

Brief computer-delivered intervention

Behavioral

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

Primary outcomes

  1. Number of Participants With Drug Use at 3 Months

    Time frame: 3 months

    The number of participants postive for drug use using participant's self-report of drug use and urinalysis. Participants were considered positive if self-report and/or urinalysis were positive.

  2. Treatment Engagement

    Time frame: 3 months

    Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Interactive Motivational Media for Perinatal Drug Abuse

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Sep 30, 2005
Registry last updated
Oct 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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