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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Alcohol Abuse
Cocaine Abuse
Marijuana Abuse
Interventions Behavioral: MI-CBT
Behavioral: Brief Advice
Enrollment 168
Recruitment Details Recruitment occurred between June 2006 and September 2009, with follow-up concluding in July 2010. Women were screened and recruited while attending obstetrical appointments in two hospital-based reproductive health clinics in New Haven and Bridgeport, CT.
Pre-assignment Details 13 women who were consented to the trial and provisionally were found to be eligible either declined or failed to complete intake, 1 had an incomplete intake and 1 was found to be ineligible at intake
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description Advice and education Motivationally-enhanced cognitive behavioral skills counseling
Period Title: Overall Study
Started 91 92
Received ≥ 1 Follow-up Assessment 86 [1] 82 [2]
Completed 86 [3] 82 [3]
Not Completed 5 10
Reason Not Completed
Withdrawal by Subject             2             5
Subject moved out of area             1             2
Lost to Follow-up             1             3
Miscarriage             1             0
[1]
1 participant did not receive any treatment sessions.
[2]
4 participants did not receive any treatment sessions.
[3]
Participants with at least 1 follow-up assessment were analyzed
Arm/Group Title Brief Advice MI-CBT Total
Hide Arm/Group Description Advice and education Motivationally-enhanced cognitive behavioral skills counseling Total of all reporting groups
Overall Number of Baseline Participants 86 82 168
Hide Baseline Analysis Population Description
Analysis excluded women with no follow-up assessments.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 168 participants
<20 years 13 16 29
20-34 years 65 61 126
>35 years 8 5 13
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 168 participants
Female
86
 100.0%
82
 100.0%
168
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 168 participants
White 17 19 36
Black 47 42 89
Hispanic 24 19 43
Other 1 2 3
[1]
Measure Description: Participants could indicate more than one race/ethnicity category. All results were counted and categorized, leading to a total count greater than the number baseline participants.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 86 participants 82 participants 168 participants
86 82 168
Education (years)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 168 participants
<12 26 32 58
12 31 35 66
13-15 23 14 37
16+ 6 1 7
Parity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 168 participants
0
35
  40.7%
31
  37.8%
66
  39.3%
1
27
  31.4%
25
  30.5%
52
  31.0%
2+
24
  27.9%
26
  31.7%
50
  29.8%
[1]
Measure Description: Parity defined as number of previous births
Gestational age at intake  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 168 participants
Weeks 1-8 5 3 8
Weeks 9-16 25 28 53
Weeks 17-24 31 27 58
Weeks 25 or later 25 24 49
Prenatal care initiation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 168 participants
Weeks 1-8 21 23 44
Weeks 9-16 47 40 87
Weeks 17-24 13 10 23
Week 25 or later 4 5 9
Unknown 1 4 5
Site  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 168 participants
Bridgeport Hospital 22 25 47
Yale New Haven Hospital 64 57 121
MINI drug or alcohol abuse or dependence  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 168 participants
Participants diagnosed with abuse or dependence 28 19 47
Participants without such a diagnosis 58 63 121
Past-month use   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 168 participants
Alcohol (any) 33 19 52
Alcohol (intoxication) 7 9 16
Heroin 1 3 4
Methadone 5 8 13
Opiates (excluding methadone) 6 4 10
Barbiturates 0 0 0
Sedatives 5 1 6
Cocaine 11 7 18
Amphetamines 1 0 1
Marijuana 40 34 74
Hallucinogens 2 1 3
Inhalants 0 0 0
[1]
Measure Description: Participants could indicate use of more than one substance in the past month. All results were counted and categorized, leading to a total count greater than the number of baseline participants.
Primary Drug   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 168 participants
Alcohol 25 26 51
Cocaine 15 14 29
Marijuana 40 37 77
Other 6 5 11
[1]
Measure Description: Primary drug was determined by combining a) self-reported recent use of substances and b) preferred substance according to the subject. If the participant used only one substance in the past 28 days, it was designated as primary. If the woman used more than one or did not endorse use of a substance in the prior 28 days, we used patient-identified primary drug. Subjects who reported more than one drug as primary were classified as "other" regardless of substances endorsed.
1.Primary Outcome
Title Percentage of Days Used Drugs or Alcohol
Hide Description [Not Specified]
Time Frame intake to delivery, an average of 21 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized participants
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 86 82
Mean (Standard Deviation)
Unit of Measure: percentage of days
Intake 18  (27) 21  (34)
Delivery 6  (17) 7  (22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments We estimated that 110 people with 10% attrition would provide 80% power
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments Not corrected for multiple comparison
Method Mixed Models Analysis
Comments 2 degrees of freedom
2.Primary Outcome
Title Percentage of Days Used Drugs or Alcohol
Hide Description [Not Specified]
Time Frame delivery to 3 months post-delivery
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized participants with data from delivery and 3 months post-delivery
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 83 80
Mean (Standard Deviation)
Unit of Measure: percentage of days
Delivery 6  (17) 7  (22)
3 months post-delivery 14  (25) 13  (24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments We estimated that 110 people with 10% attrition would provide 80% power.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments Not corrected for multiple comparison.
Method Mixed Models Analysis
Comments 2 degrees of freedom
3.Primary Outcome
Title Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Hide Description [Not Specified]
Time Frame intake to delivery, an average of 21 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without a baseline diagnosis of drug use or dependence.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 58 63
Mean (Standard Deviation)
Unit of Measure: percentage of days
Intake 14  (25) 15  (27)
Delivery 4  (11) 6  (20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Primary Outcome
Title Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Hide Description [Not Specified]
Time Frame Delivery to 3 months post-delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without a baseline diagnosis for drug abuse or dependence with data available for time frame.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 55 62
Mean (Standard Deviation)
Unit of Measure: percentage of days
Delivery 4  (11) 6  (20)
3 months post-delivery 11  (20) 14  (27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Primary Outcome
Title Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Hide Description [Not Specified]
Time Frame intake to delivery, an average of 21 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline diagnosis for drug abuse or dependence.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 28 19
Mean (Standard Deviation)
Unit of Measure: percentage of days
Intake 27  (29) 40  (45)
Delivery 10  (25) 13  (28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Primary Outcome
Title Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Hide Description [Not Specified]
Time Frame Delivery to 3 months post-delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 28 18
Mean (Standard Deviation)
Unit of Measure: percentage of days
Delivery 10  (25) 13  (28)
3 months post-delivery 18  (32) 8  (8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
7.Secondary Outcome
Title Incidence of Preterm Births
Hide Description [Not Specified]
Time Frame At delivery
Hide Outcome Measure Data
Hide Analysis Population Description
A singleton live birth occurred in 163 subjects, and 5 had twins. Data was collected from the 84 women of the Brief Advice category and the 79 women of the MI-CBT category who had singleton live births.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 84 79
Measure Type: Number
Unit of Measure: preterm births
17 8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Secondary Outcome
Title Incidence of Low Birth Weight
Hide Description [Not Specified]
Time Frame At delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Only singleton live births, which occurred in 163 subjects, were analyzed. Three of the women in the MI-CBT group had an infant of unknown birth weight, and were not included in analysis.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 84 76
Measure Type: Number
Unit of Measure: low weight births
17 11
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Hide Description [Not Specified]
Time Frame intake to delivery, an average of 21 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 86 82
Measure Type: Number
Unit of Measure: proportion of participants
Intake 0.41 0.49
Delivery 0.75 0.76
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value .77
Confidence Interval (2-Sided) 95%
0.36 to 1.67
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Hide Description [Not Specified]
Time Frame Delivery to 3 months post-delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with data available from the time frame.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 83 80
Measure Type: Number
Unit of Measure: proportion of participants
Delivery 0.75 0.76
3 months post-delivery 0.38 0.41
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.42 to 2.62
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine
Hide Description [Not Specified]
Time Frame intake to delivery, an average of 21 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants for whom urine test data was available.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 80 81
Measure Type: Number
Unit of Measure: proportion of participants
Intake 0.54 0.56
Delivery 0.84 0.84
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.34 to 2.72
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Proportion of Participants Abstinent From Drugs According to Urine
Hide Description Based on urine tests for marijuana, cocaine, or opioids
Time Frame Delivery to 3 months post-delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants for whom urine data was available during the time frame.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 51 55
Measure Type: Number
Unit of Measure: proportion of participants
Delivery 0.84 0.84
3 months post-delivery 0.52 0.59
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.57 to 2.57
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Hide Description Based on urine tests for marijuana, cocaine or opioids.
Time Frame intake to delivery, an average of 21 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with both self-report and urine data available.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 80 81
Measure Type: Number
Unit of Measure: proportion of participants
Intake 0.33 0.43
Delivery 0.76 0.75
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.32 to 1.84
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Hide Description Based on urine tests for marijuana, cocaine, or opioids.
Time Frame Delivery to 3 months post-delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with both self-report and urine data available during the time frame.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 51 55
Measure Type: Number
Unit of Measure: proportion of participants
Delivery 0.76 0.75
3 months post-delivery 0.34 0.33
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.27 to 2.11
Estimation Comments [Not Specified]
15.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame intake to delivery, an average of 21 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without a baseline diagnosis of drug abuse or dependence.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 58 63
Measure Type: Number
Unit of Measure: proportion of participants
Intake 0.50 0.52
Delivery 0.76 0.81
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.44 to 3.14
Estimation Comments [Not Specified]
16.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Delivery to 3 months post-delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without a baseline diagnosis of drug abuse or dependence with data available for the time frame.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 55 62
Measure Type: Number
Unit of Measure: proportion of participants
Delivery 0.76 0.81
3 months post-delivery 0.28 0.44
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.46
Confidence Interval (2-Sided) 95%
0.47 to 4.52
Estimation Comments [Not Specified]
17.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame intake to delivery, an average of 21 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline diagnosis of drug abuse or dependence.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 28 19
Measure Type: Number
Unit of Measure: proportion of participants
Intake 0.21 0.37
Delivery 0.71 0.61
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
0.08 to 1.02
Estimation Comments [Not Specified]
18.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Delivery to 3 months post-delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 28 18
Measure Type: Number
Unit of Measure: proportion of participants
Delivery 0.71 0.61
3 months post-delivery 0.54 0.31
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.10 to 3.90
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Hide Description Based on urine tests for marijuana, cocaine or opioids.
Time Frame intake to delivery, an average of 21 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without a baseline diagnosis for drug abuse or dependence and with urine data.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 52 62
Measure Type: Number
Unit of Measure: proportion of participants
Intake 0.56 0.60
Delivery 0.82 0.85
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.32 to 4.20
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Hide Description Based on urine tests for marijuana, cocaine or opioids.
Time Frame Delivery to 3 months post-delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without a baseline diagnosis of drug abuse or dependence and urine data during the time frame.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 33 46
Measure Type: Number
Unit of Measure: proportion of participants
Delivery 0.82 0.85
3 months post-delivery 0.46 0.58
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.33
Confidence Interval (2-Sided) 95%
0.35 to 5.07
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Hide Description Based on urine tests for marijuana, cocaine or opioids.
Time Frame intake to delivery, an average of 21 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 28 19
Measure Type: Number
Unit of Measure: proportion of participants
Intake 0.50 0.42
Delivery 0.89 0.78
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.14 to 5.23
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Hide Description Based on urine tests for marijuana, cocaine or opioids.
Time Frame Delivery to 3 months post-delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 18 9
Measure Type: Number
Unit of Measure: proportion of participants
Delivery 0.89 0.78
3 months post-delivery 0.60 0.63
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
0.21 to 7.12
Estimation Comments [Not Specified]
23.Secondary Outcome
Title 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
Hide Description Based on urine tests for marijuana, cocaine or opioids.
Time Frame intake to delivery, an average of 21 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 52 62
Measure Type: Number
Unit of Measure: proportion of participants
Intake 0.42 0.47
Delivery 0.76 0.76
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .04
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
0.46 to 3.55
Estimation Comments [Not Specified]
24.Secondary Outcome
Title 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
Hide Description Based on urine tests for marijuana, cocaine or opioids
Time Frame Delivery to 3 months post-delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 33 46
Measure Type: Number
Unit of Measure: proportion of participants
Delivery 0.76 0.76
3 months post-delivery 0.23 0.35
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.35 to 4.17
Estimation Comments [Not Specified]
25.Secondary Outcome
Title 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
Hide Description Based on urine tests for marijuana, cocaine or opioids
Time Frame intake to delivery, an average of 21 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline diagnosis for drug abuse or dependence, and with both self-report and urine data.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 28 19
Measure Type: Number
Unit of Measure: proportion of participants
Intake 0.14 0.32
Delivery 0.78 0.67
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
0.04 to 1.63
Estimation Comments [Not Specified]
26.Secondary Outcome
Title 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
Hide Description Based on urine tests for marijuana, cocaine or opioids
Time Frame Delivery to 3 months post-delivery
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 18 9
Measure Type: Number
Unit of Measure: proportion of participants
Delivery 0.78 0.67
3 months post-delivery 0.52 0.25
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
0.04 to 3.74
Estimation Comments [Not Specified]
27.Other Pre-specified Outcome
Title Adequacy of Received Services
Hide Description 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.
Time Frame After prenatal care initiation
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants, 6 women had unkown attendance.
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 86 82
Measure Type: Number
Unit of Measure: participants
Inadequate (0-49% attendance) 2 2
Intermediate (50%-79% attendance) 7 13
Adequate (80%-109% attendance) 24 33
Adequate plus (110+%) 51 30
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
28.Other Pre-specified Outcome
Title Attendance of Treatment Outside the Study
Hide Description The number of patients who attended outside treatment in the 30 days prior to each assessment.
Time Frame 30 days prior to assessment
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized participants with data availabe at time frames
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description:
Advice and education
Motivationally-enhanced cognitive behavioral skills counseling
Overall Number of Participants Analyzed 86 82
Measure Type: Number
Unit of Measure: participants
Participants who attended prior to delivery 4 6
Participants who attended prior to 3 months post 9 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brief Advice, MI-CBT
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brief Advice MI-CBT
Hide Arm/Group Description Advice and education Motivationally-enhanced cognitive behavioral skills counseling
All-Cause Mortality
Brief Advice MI-CBT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Brief Advice MI-CBT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/82 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Brief Advice MI-CBT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/82 (0.00%) 
Did not acheive desired sample size; results were averaged across substances; women were not seeking substance abuse treatment (i.e. they were attending for prenatal care); treatment was brief
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kimberly Yonkers
Organization: Yale University
Phone: 1-203-764-6621
EMail: Kimberly.Yonkers@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00227903    
Other Study ID Numbers: 0402026466
R01DA019135 ( U.S. NIH Grant/Contract )
First Submitted: September 27, 2005
First Posted: September 28, 2005
Results First Submitted: June 14, 2013
Results First Posted: August 21, 2013
Last Update Posted: April 15, 2020