NCT00685074

Brief Summary

The purpose of the study is to see if a brief computer program can help new mothers cut down or quit tobacco, alcohol, or drug use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2007

Typical duration for phase_1

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, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 14, 2011

Status Verified

October 1, 2011

Enrollment Period

3.5 years

First QC Date

May 23, 2008

Last Update Submit

October 12, 2011

Conditions

Substance Abuse

Keywords

Motivational InterviewComputer based interventionSubstance abusepost-partum

Outcome Measures

Primary Outcomes (2)

  • Drug use at 3 months

    3 months

  • Drug use at 6 months

    6 months

Study Arms (2)

Brief computer-delivered intervention for drug use

EXPERIMENTAL

A single interactive computer intervention based primarily on Motivational Interviewing principles.

Behavioral: Computer-based Motivational Interviewing

Time control for drug use

PLACEBO COMPARATOR

An series of innocuous and therapeutically inactive computer segments.

Behavioral: Time control

Interventions

Computer-based Motivational InterviewingBEHAVIORAL

The software includes three intervention components - pros and cons, feedback, and optional goal-setting in a fixed order.

Also known as: Motivation Enhancement System
Brief computer-delivered intervention for drug use
Time controlBEHAVIORAL

A series of therapeutically inactive videos and questions to (a) maintain RA blind, and (b) serve as a time control.

Time control for drug use

Eligibility Criteria

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

You may qualify if:

  • Hospitalized women in immediate post-partum period
  • Self report of illicit drug use, problem alcohol use, or tobacco use in month prior to pregnancy

You may not qualify if:

  • Frank psychosis or other cognitive impairment
  • Inability to communicate in English
  • No sleep since giving birth
  • Recent receipt of narcotic pain medication
  • Grieving over medically compromised infant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hutzel Women's Hospital

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Flowering time control protein FCA, Arabidopsis

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Steven J. Ondersma, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
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

May 23, 2008

First Posted

May 28, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

October 14, 2011

Record last verified: 2011-10

Locations

US(1)