Alcohol Abuse Clinical Trial
— PRIDE-POfficial title:
Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)
Verified date | April 2020 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 168 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 16 Years to 45 Years |
Eligibility |
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. - |
Country | Name | City | State |
---|---|---|---|
United States | Bridgeport Hospital | Bridgeport | Connecticut |
United States | Yale-New Haven Hospital | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Drug Abuse (NIDA) |
United States,
Hine CE, Howell HB, Yonkers KA. Integration of medical and psychological treatment within the primary health care setting. Soc Work Health Care. 2008;47(2):122-34. doi: 10.1080/00981380801970244. Review. — View Citation
Quesada O, Gotman N, Howell HB, Funai EF, Rounsaville BJ, Yonkers KA. Prenatal hazardous substance use and adverse birth outcomes. J Matern Fetal Neonatal Med. 2012 Aug;25(8):1222-7. doi: 10.3109/14767058.2011.602143. Epub 2012 May 11. — View Citation
Yonkers KA, Forray A, Howell HB, Gotman N, Kershaw T, Rounsaville BJ, Carroll KM. Motivational enhancement therapy coupled with cognitive behavioral therapy versus brief advice: a randomized trial for treatment of hazardous substance use in pregnancy and — View Citation
Yonkers KA, Gotman N, Kershaw T, Forray A, Howell HB, Rounsaville BJ. Screening for prenatal substance use: development of the Substance Use Risk Profile-Pregnancy scale. Obstet Gynecol. 2010 Oct;116(4):827-33. doi: 10.1097/AOG.0b013e3181ed8290. — View Citation
Yonkers KA, Howell HB, Allen AE, Ball SA, Pantalon MV, Rounsaville BJ. A treatment for substance abusing pregnant women. Arch Womens Ment Health. 2009 Aug;12(4):221-7. doi: 10.1007/s00737-009-0069-2. Epub 2009 Apr 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adequacy of Received Services | Based on prenatal care attendance: the percent of visits attended after prenatal care initiation, accounting for time of delivery. Attendance was rated according to the Kotelchuck Adequacy of Prenatal Care Index. Only the normally scheduled prenatal car visits were included. | After prenatal care initiation | |
Other | Attendance of Treatment Outside the Study | The number of patients who attended outside treatment in the 30 days prior to each assessment. | 30 days prior to assessment | |
Primary | Percentage of Days Used Drugs or Alcohol | intake to delivery, an average of 21 weeks | ||
Primary | Percentage of Days Used Drugs or Alcohol | delivery to 3 months post-delivery | ||
Primary | Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | intake to delivery, an average of 21 weeks | ||
Primary | Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | Delivery to 3 months post-delivery | ||
Primary | Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | intake to delivery, an average of 21 weeks | ||
Primary | Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | Delivery to 3 months post-delivery | ||
Secondary | Incidence of Preterm Births | At delivery | ||
Secondary | Incidence of Low Birth Weight | At delivery | ||
Secondary | Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | intake to delivery, an average of 21 weeks | ||
Secondary | Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | Delivery to 3 months post-delivery | ||
Secondary | Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine | intake to delivery, an average of 21 weeks | ||
Secondary | Proportion of Participants Abstinent From Drugs According to Urine | Based on urine tests for marijuana, cocaine, or opioids | Delivery to 3 months post-delivery | |
Secondary | 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. | intake to delivery, an average of 21 weeks | |
Secondary | 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. | Delivery to 3 months post-delivery | |
Secondary | 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 | intake to delivery, an average of 21 weeks | ||
Secondary | 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 | ||
Secondary | 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 | intake to delivery, an average of 21 weeks | ||
Secondary | 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 | ||
Secondary | 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. | intake to delivery, an average of 21 weeks | |
Secondary | 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. | Delivery to 3 months post-delivery | |
Secondary | 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. | intake to delivery, an average of 21 weeks | |
Secondary | 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. | Delivery to 3 months post-delivery | |
Secondary | 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. | intake to delivery, an average of 21 weeks | |
Secondary | 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 | Delivery to 3 months post-delivery | |
Secondary | 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 | intake to delivery, an average of 21 weeks | |
Secondary | 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 | Delivery to 3 months post-delivery |
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