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Computer-based Brief Intervention for Perinatal Substance Abuse

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00685074
Enrollment
143
Registered
2008-05-28
Start date
2007-09-30
Completion date
2011-03-31
Last updated
2011-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Abuse

Keywords

Motivational Interview, Computer based intervention, Substance abuse, post-partum

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.

Interventions

BEHAVIORALComputer-based Motivational Interviewing

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

BEHAVIORALTime control

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

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Wayne State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Drug use at 3 months3 months
Drug use at 6 months6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026