Interactive Motivational Media for Perinatal Drug Abuse - 3

Substance-Related Disorders Clinical Trial

Official title:

Interactive Motivational Media for Perinatal Drug Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230048
• Other study ID #: NIDA-14621-3
• Secondary ID: R21DA014621
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2005
• Last updated: October 29, 2012
• Start date: September 2001
• Est. completion date: February 2006

Study information

• Verified date: October 2012
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Interactive Motivational Media for Perinatal Drug Abuse

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Epub 2007 Jan 22. Erratum in: Am J Prev Med. 2007 Jun;32(6):549. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Drug Use at 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.	3 months	No
Primary	Treatment Engagement	Completing at least a single intake or treatment session of any kind, focused on substance use within the previous 3 months.	3 months	No