Computer-based Brief Intervention for Perinatal Substance Abuse

Wayne State University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Substance Abuse

Treatments: Behavioral: Time control; Behavioral: Computer-based Motivational Interviewing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00685074

MES-III

5R01DA021329-04 (U.S. NIH Grant/Contract)

DA021329-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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143 participants in 2 patient groups, including a placebo group

Brief computer-delivered intervention for drug use

Experimental group

Description:

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

Treatment:

Behavioral: Computer-based Motivational Interviewing

Time control for drug use

Placebo Comparator group

Description:

An series of innocuous and therapeutically inactive computer segments.

Treatment:

Behavioral: Time control