Therapeutic Substance Abuse Treatment in Pregnancy - 1 (PRIDE-P)

• ClinicalTrials.gov Identifier: NCT00227903
• Recruitment Status: Completed
• First Posted: September 28, 2005
• Results First Posted: August 21, 2013
• Last Update Posted: April 15, 2020
• Sponsor: Yale University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Yale University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Alcohol Abuse; Cocaine Abuse; Marijuana Abuse	Behavioral: MI-CBT; Behavioral: Brief Advice	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)
• Study Start Date: September 2004
• Actual Primary Completion Date: August 2010
• Actual Study Completion Date: August 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: MI-CBT; Motivationally-enhanced cognitive behavioral skills counseling	Behavioral: MI-CBT; Motivationally-enhanced cognitive behavioral skills counseling
Active Comparator: Brief Advice; Advice and education	Behavioral: Brief Advice; Advice and education

Outcome Measures

Primary Outcome Measures :

1. Percentage of Days Used Drugs or Alcohol [ Time Frame: intake to delivery, an average of 21 weeks ]
2. Percentage of Days Used Drugs or Alcohol [ Time Frame: delivery to 3 months post-delivery ]
3. 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 ]
4. 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 ]
5. 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 ]
6. 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 Outcome Measures :

1. Incidence of Preterm Births [ Time Frame: At delivery ]
2. Incidence of Low Birth Weight [ Time Frame: At delivery ]
3. 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 ]
4. Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [ Time Frame: Delivery to 3 months post-delivery ]
5. 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 ]
6. Proportion of Participants Abstinent From Drugs According to Urine [ Time Frame: Delivery to 3 months post-delivery ]
   Based on urine tests for marijuana, cocaine, or opioids
7. Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [ Time Frame: intake to delivery, an average of 21 weeks ]
   Based on urine tests for marijuana, cocaine or opioids.
8. Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [ Time Frame: Delivery to 3 months post-delivery ]
   Based on urine tests for marijuana, cocaine, or opioids.
9. 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 ]
10. 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 ]
11. 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 ]
12. 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 ]
13. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [ Time Frame: intake to delivery, an average of 21 weeks ]
    Based on urine tests for marijuana, cocaine or opioids.
14. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [ Time Frame: Delivery to 3 months post-delivery ]
    Based on urine tests for marijuana, cocaine or opioids.
15. Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [ Time Frame: intake to delivery, an average of 21 weeks ]
    Based on urine tests for marijuana, cocaine or opioids.
16. Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [ Time Frame: Delivery to 3 months post-delivery ]
    Based on urine tests for marijuana, cocaine or opioids.
17. 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 [ Time Frame: intake to delivery, an average of 21 weeks ]
    Based on urine tests for marijuana, cocaine or opioids.
18. 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 [ Time Frame: Delivery to 3 months post-delivery ]
    Based on urine tests for marijuana, cocaine or opioids
19. 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 [ Time Frame: intake to delivery, an average of 21 weeks ]
    Based on urine tests for marijuana, cocaine or opioids
20. 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 [ Time Frame: Delivery to 3 months post-delivery ]
    Based on urine tests for marijuana, cocaine or opioids

Other Outcome Measures:

1. Adequacy of Received Services [ Time Frame: After prenatal care initiation ]
   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.
2. Attendance of Treatment Outside the Study [ Time Frame: 30 days prior to assessment ]
   The number of patients who attended outside treatment in the 30 days prior to each assessment.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 45 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

-

Contacts and Locations

Locations

United States, Connecticut

Bridgeport Hospital

Bridgeport, Connecticut, United States, 06106

Yale-New Haven Hospital

New Haven, Connecticut, United States, 06510

Sponsors and Collaborators

Yale University

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Kimberly A Yonkers, M.D.; Yale University

More Information

Publications of Results:

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 after delivery. Gen Hosp Psychiatry. 2012 Sep-Oct;34(5):439-49. doi: 10.1016/j.genhosppsych.2012.06.002. Epub 2012 Jul 12.

Other Publications:

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.

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.

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):827-833. doi: 10.1097/AOG.0b013e3181ed8290.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Xu X, Yonkers KA, Ruger JP. Economic evaluation of a behavioral intervention versus brief advice for substance use treatment in pregnant women: results from a randomized controlled trial. BMC Pregnancy Childbirth. 2017 Mar 7;17(1):83. doi: 10.1186/s12884-017-1260-5.

Forray A, Gotman N, Kershaw T, Yonkers KA. Perinatal smoking and depression in women with concurrent substance use. Addict Behav. 2014 Apr;39(4):749-56. doi: 10.1016/j.addbeh.2013.12.008. Epub 2013 Dec 17.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00227903
• Other Study ID Numbers: 0402026466; R01DA019135 ( U.S. NIH Grant/Contract )
• First Posted: September 28, 2005
• Results First Posted: August 21, 2013
• Last Update Posted: April 15, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: only aggregate de-identified data

Additional relevant MeSH terms:

Marijuana Abuse; Alcoholism; Cocaine-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders