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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Motivationally-enhanced cognitive behavioral skills counseling
Advice and education
Bridgeport Hospital
Bridgeport, Connecticut, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
Percentage of Days Used Drugs or Alcohol
Time frame: intake to delivery, an average of 21 weeks
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: intake to delivery, an average of 21 weeks
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: intake to delivery, an average of 21 weeks
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
Incidence of Preterm Births
Time frame: At delivery
Incidence of Low Birth Weight
Time frame: At delivery
Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
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Time frame: Delivery to 3 months post-delivery
Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants Abstinent From Drugs According to Urine
Based on urine tests for marijuana, cocaine, or opioids
Time frame: Delivery to 3 months post-delivery
Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Based on urine tests for marijuana, cocaine or opioids.
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Based on urine tests for marijuana, cocaine, or opioids.
Time frame: 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
Time frame: intake to delivery, an average of 21 weeks
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
Time frame: 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
Time frame: intake to delivery, an average of 21 weeks
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
Time frame: Delivery to 3 months post-delivery
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Based on urine tests for marijuana, cocaine or opioids.
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Based on urine tests for marijuana, cocaine or opioids.
Time frame: Delivery to 3 months post-delivery
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Based on urine tests for marijuana, cocaine or opioids.
Time frame: intake to delivery, an average of 21 weeks
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Based on urine tests for marijuana, cocaine or opioids.
Time frame: 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
Based on urine tests for marijuana, cocaine or opioids.
Time frame: intake to delivery, an average of 21 weeks
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
Based on urine tests for marijuana, cocaine or opioids
Time frame: 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
Based on urine tests for marijuana, cocaine or opioids
Time frame: intake to delivery, an average of 21 weeks
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
Based on urine tests for marijuana, cocaine or opioids
Time frame: Delivery to 3 months post-delivery