Interactive Motivational Media for Perinatal Drug Abuse - 3

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven J. Ondersma, Wayne State University
ClinicalTrials.gov Identifier:
NCT00230048
First received: September 29, 2005
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

Interactive Motivational Media for Perinatal Drug Abuse


Condition Intervention Phase
Substance-Related Disorders
Behavioral: Brief computer-delivered intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interactive Motivational Media for Perinatal Drug Abuse

Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Number of Participants With Drug Use at 3 Months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Treatment Engagement [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months.


Enrollment: 107
Study Start Date: September 2001
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Assessment only
Experimental: Brief intervention Behavioral: Brief computer-delivered intervention
Brief (20-minute) computer delivered intervention, plus two subsequent non-tailored mailings.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230048

Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48207
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Steven J Ondersma, Ph.D. ACT
  More Information

Publications:
Responsible Party: Steven J. Ondersma, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT00230048     History of Changes
Other Study ID Numbers: NIDA-14621-3, R21DA014621
Study First Received: September 29, 2005
Results First Received: October 12, 2011
Last Updated: October 29, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014