NCT00230048

Brief Summary

Interactive Motivational Media for Perinatal Drug Abuse

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

August 16, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

4.4 years

First QC Date

September 29, 2005

Results QC Date

October 12, 2011

Last Update Submit

October 29, 2012

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Assessment only

NO INTERVENTION

Brief intervention

EXPERIMENTAL
Behavioral: Brief computer-delivered intervention

Interventions

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

Brief intervention

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Screen positive for drug use (self-report)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48207, United States

Location

Related 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. doi: 10.1016/j.jsat.2005.02.004.

  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Limitations and Caveats

Generalizability limited by relatively small sample, attrition of 29%, and restriction to low-income mothers. Second, power limitations prevented verification of effects on the dichotomous outcomes, despite effects in the small-moderate range.

Results Point of Contact

Title
Steven J. Ondersma
Organization
Wayne State University

Study Officials

  • Steven J Ondersma, Ph.D.

    ACT

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 29, 2005

First Posted

September 30, 2005

Study Start

September 1, 2001

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

October 31, 2012

Results First Posted

August 16, 2012

Record last verified: 2012-10

Locations