Computer-based Brief Intervention for Perinatal Substance Abuse

Substance Abuse Clinical Trial

Official title:

Computer-based Brief Intervention for Perinatal Drug, Alcohol, and Tobacco Abuse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685074
• Other study ID #: MES-III
• Secondary ID: 5R01DA021329-04D
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 23, 2008
• Last updated: October 12, 2011
• Start date: September 2007
• Est. completion date: March 2011

Study information

• Verified date: October 2011
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

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 Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• Computer-based Motivational Interviewing
The software includes three intervention components - pros and cons, feedback, and optional goal-setting in a fixed order.
• Time control
A series of therapeutically inactive videos and questions to (a) maintain RA blind, and (b) serve as a time control.

Locations

Country	Name	City	State
United States	Hutzel Women's Hospital	Detroit	Michigan

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug use at 3 months		3 months	No
Primary	Drug use at 6 months		6 months	No