Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Alcohol Abuse
- Sponsor
- Yale University
- Enrollment
- 168
- Locations
- 2
- Primary Endpoint
- Percentage of Days Used Drugs or Alcohol
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is... To assess whether a behavioral treatment that combines motivational enhancement and cognitive skills training therapy (MET-CBT) is more effective than brief advice in: 1) decreasing use of a full range of psychoactive substances (e.g. marijuana, cocaine, methamphetamines, alcohol, nicotine, opioids) in pregnant substance using and dependent women; 2) decreasing HIV risk behavior; 3) improving birth outcomes (longer gestations and greater birth weight).
Detailed Description
We propose an integrated system of counseling services onsite in primary care obstetrical clinics, comparing a manualized brief advice (closely approximating "treatment as usual") to manualized motivationally enhanced cognitive behavioral therapy. Treatment providers are obstetrical nurses. Therapy patients are taught skill sets designed to enhance motivation to abstain from drugs of abuse, as well as designed to prevent relapse during the perinatal period. It is our hypothesis that therapy patients will be more successful at achieving stated study aims than those receiving brief advice.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnant women, age 16 or older, alcohol or illicit drug use in the past 30 days -
Exclusion Criteria
- •Nonfluent in English or Spanish, pending incarceration, psychotic, cognitively unable to give informed consent, actively suicidal or homicidal, already engaged in addictions treatment, primarily addicted to nicotine or heroin.
Outcomes
Primary Outcomes
Percentage of Days Used Drugs or Alcohol
Time Frame: delivery to 3 months post-delivery
Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Time Frame: Delivery to 3 months post-delivery
Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Time Frame: Delivery to 3 months post-delivery
Secondary Outcomes
- Incidence of Preterm Births(At delivery)
- Incidence of Low Birth Weight(At delivery)
- Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report(Delivery to 3 months post-delivery)
- Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine(intake to delivery, an average of 21 weeks)
- Proportion of Participants Abstinent From Drugs According to Urine(Delivery to 3 months post-delivery)
- Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine(Delivery to 3 months post-delivery)
- Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report(Delivery to 3 months post-delivery)
- Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report(Delivery to 3 months post-delivery)
- Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine(Delivery to 3 months post-delivery)
- Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine(Delivery to 3 months post-delivery)
- Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine(Delivery to 3 months post-delivery)
- Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine(Delivery to 3 months post-delivery)