Computer-based Brief Intervention for Perinatal Substance Abuse

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Substance Abuse

Intervention / Treatment
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* Behavioral: Computer-based Motivational Interviewing
* Behavioral: Time control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief computer-delivered intervention for drug use<br>A single interactive computer intervention based primarily on Motivational Interviewing principles. | Behavioral: Computer-based Motivational Interviewing<br>* The software includes three intervention components - pros and cons, feedback, and optional goal-setting in a fixed order.<br>* Other names: Motivation Enhancement System;|
| Placebo Comparator: Time control for drug use<br>An series of innocuous and therapeutically inactive computer segments. | Behavioral: Time control<br>* A series of therapeutically inactive videos and questions to (a) maintain RA blind, and (b) serve as a time control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use at 3 months |  | 3 months | 
| Drug use at 6 months |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motivational Interview, Computer based intervention, Substance abuse, post-partum