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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

September 29, 2005
October 29, 2012
September 2001
February 2006   (final data collection date for primary outcome measure)
  • 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.
  • Treatment engagement
  • Amount of drug use
Complete list of historical versions of study NCT00230048 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Interactive Motivational Media for Perinatal Drug Abuse - 3
Interactive Motivational Media for Perinatal Drug Abuse

Interactive Motivational Media for Perinatal Drug Abuse

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Substance-Related Disorders
Behavioral: Brief computer-delivered intervention
Brief (20-minute) computer delivered intervention, plus two subsequent non-tailored mailings.
  • No Intervention: Assessment only
  • Experimental: Brief intervention
    Intervention: Behavioral: Brief computer-delivered intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
February 2006
February 2006   (final data collection date for primary outcome measure)

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

Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00230048
NIDA-14621-3, R21DA014621
No
Steven J. Ondersma, Wayne State University
Wayne State University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Steven J Ondersma, Ph.D. ACT
Wayne State University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP