Computer-based Brief Intervention for Perinatal Substance Abuse

NCT ID: NCT00685074

Last Updated: 2011-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-03-31

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.

Detailed Description

The purpose of this Stage I/II intervention study (that is, Stage II for drug use and Stage I for alcohol use and smoking) is to test the efficacy of a brief, computerized motivational intervention for substance abuse among post-partum women. The study will randomly assign 350 post-partum women to either intervention or control conditions, with intervention itself taking approximately 30 minutes in the period before the participant leaves the hospital. Inclusion criteria will include post-partum status, age between 18 and 45, ability to understand spoken English, and meeting criteria for one of the three substance use groups: any illicit drug use in month prior to pregnancy, meeting T-ACE criteria for problem alcohol use, or smoking in past month. Exclusion criteria will include receipt of narcotic pain medication in the past 3 hours, no sleep since giving birth, and inability to provide informed consent (e.g., due to psychosis or other clear cognitive impairment).

Lab-based follow-up will occur at 3- and 6-months postpartum. The primary outcomes will be participant report of frequency of substance use and toxicological analyses of substance use (urinalysis and expired breath CO at 3 and 6 month follow-up, hair analysis at 6-month follow-up). Secondary outcome measures include HIV risk behaviors, receipt of treatment services, motivation to change, self-efficacy, mental health functioning, violence exposure, and consequences related to substance use.

Conditions

Substance Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brief computer-delivered intervention for drug use

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

Group Type: EXPERIMENTAL

Computer-based Motivational Interviewing

Intervention Type: BEHAVIORAL

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

Time control for drug use

An series of innocuous and therapeutically inactive computer segments.

Group Type: PLACEBO_COMPARATOR

Time control

Intervention Type: BEHAVIORAL

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

Interventions

Computer-based Motivational Interviewing

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

Intervention Type: BEHAVIORAL

Time control

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Motivation Enhancement System

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Steven J. Ondersma

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven J. Ondersma, PhD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Hutzel Women's Hospital

Detroit, Michigan, United States

Countries

United States

Other Identifiers

5R01DA021329-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DA021329-01

Identifier Type: -

Identifier Source: secondary_id

MES-III

Identifier Type: -

Identifier Source: org_study_id