Trial Outcomes & Findings for Therapeutic Substance Abuse Treatment in Pregnancy - 1 (NCT NCT00227903)
NCT ID: NCT00227903
Last Updated: 2020-04-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
168 participants
Primary outcome timeframe
intake to delivery, an average of 21 weeks
Results posted on
2020-04-15
Participant Flow
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.
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
Participant milestones
| Measure |
Brief Advice
Advice and education
|
MI-CBT
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
92
|
|
Overall Study
Received ≥ 1 Follow-up Assessment
|
86
|
82
|
|
Overall Study
COMPLETED
|
86
|
82
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
| Measure |
Brief Advice
Advice and education
|
MI-CBT
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
|
Overall Study
Subject moved out of area
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Miscarriage
|
1
|
0
|
Baseline Characteristics
Therapeutic Substance Abuse Treatment in Pregnancy - 1
Baseline characteristics by cohort
| Measure |
Brief Advice
n=86 Participants
Advice and education
|
MI-CBT
n=82 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<20 years
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Age, Customized
20-34 years
|
65 participants
n=5 Participants
|
61 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Age, Customized
>35 years
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
47 participants
n=5 Participants
|
42 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
24 participants
n=5 Participants
|
19 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=5 Participants
|
82 participants
n=7 Participants
|
168 participants
n=5 Participants
|
|
Education (years)
<12
|
26 participants
n=5 Participants
|
32 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Education (years)
12
|
31 participants
n=5 Participants
|
35 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Education (years)
13-15
|
23 participants
n=5 Participants
|
14 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Education (years)
16+
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Parity
0
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Parity
1
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Parity
2+
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Gestational age at intake
Weeks 1-8
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Gestational age at intake
Weeks 9-16
|
25 participants
n=5 Participants
|
28 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Gestational age at intake
Weeks 17-24
|
31 participants
n=5 Participants
|
27 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Gestational age at intake
Weeks 25 or later
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Prenatal care initiation
Weeks 1-8
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Prenatal care initiation
Weeks 9-16
|
47 participants
n=5 Participants
|
40 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Prenatal care initiation
Weeks 17-24
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Prenatal care initiation
Week 25 or later
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Prenatal care initiation
Unknown
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Site
Bridgeport Hospital
|
22 participants
n=5 Participants
|
25 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Site
Yale New Haven Hospital
|
64 participants
n=5 Participants
|
57 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
MINI drug or alcohol abuse or dependence
Participants diagnosed with abuse or dependence
|
28 participants
n=5 Participants
|
19 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
MINI drug or alcohol abuse or dependence
Participants without such a diagnosis
|
58 participants
n=5 Participants
|
63 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Past-month use
Alcohol (any)
|
33 participants
n=5 Participants
|
19 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Past-month use
Alcohol (intoxication)
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Past-month use
Heroin
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Past-month use
Methadone
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Past-month use
Opiates (excluding methadone)
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Past-month use
Barbiturates
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Past-month use
Sedatives
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Past-month use
Cocaine
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Past-month use
Amphetamines
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Past-month use
Marijuana
|
40 participants
n=5 Participants
|
34 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Past-month use
Hallucinogens
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Past-month use
Inhalants
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Primary Drug
Alcohol
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Primary Drug
Cocaine
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Primary Drug
Marijuana
|
40 participants
n=5 Participants
|
37 participants
n=7 Participants
|
77 participants
n=5 Participants
|
|
Primary Drug
Other
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: intake to delivery, an average of 21 weeksPopulation: all randomized participants
Outcome measures
| Measure |
Brief Advice
n=86 Participants
Advice and education
|
MI-CBT
n=82 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Percentage of Days Used Drugs or Alcohol
Intake
|
18 percentage of days
Standard Deviation 27
|
21 percentage of days
Standard Deviation 34
|
|
Percentage of Days Used Drugs or Alcohol
Delivery
|
6 percentage of days
Standard Deviation 17
|
7 percentage of days
Standard Deviation 22
|
PRIMARY outcome
Timeframe: delivery to 3 months post-deliveryPopulation: all randomized participants with data from delivery and 3 months post-delivery
Outcome measures
| Measure |
Brief Advice
n=83 Participants
Advice and education
|
MI-CBT
n=80 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Percentage of Days Used Drugs or Alcohol
Delivery
|
6 percentage of days
Standard Deviation 17
|
7 percentage of days
Standard Deviation 22
|
|
Percentage of Days Used Drugs or Alcohol
3 months post-delivery
|
14 percentage of days
Standard Deviation 25
|
13 percentage of days
Standard Deviation 24
|
PRIMARY outcome
Timeframe: intake to delivery, an average of 21 weeksPopulation: All randomized participants without a baseline diagnosis of drug use or dependence.
Outcome measures
| Measure |
Brief Advice
n=58 Participants
Advice and education
|
MI-CBT
n=63 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Intake
|
14 percentage of days
Standard Deviation 25
|
15 percentage of days
Standard Deviation 27
|
|
Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Delivery
|
4 percentage of days
Standard Deviation 11
|
6 percentage of days
Standard Deviation 20
|
PRIMARY outcome
Timeframe: Delivery to 3 months post-deliveryPopulation: All randomized participants without a baseline diagnosis for drug abuse or dependence with data available for time frame.
Outcome measures
| Measure |
Brief Advice
n=55 Participants
Advice and education
|
MI-CBT
n=62 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Delivery
|
4 percentage of days
Standard Deviation 11
|
6 percentage of days
Standard Deviation 20
|
|
Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
3 months post-delivery
|
11 percentage of days
Standard Deviation 20
|
14 percentage of days
Standard Deviation 27
|
PRIMARY outcome
Timeframe: intake to delivery, an average of 21 weeksPopulation: All randomized participants with a baseline diagnosis for drug abuse or dependence.
Outcome measures
| Measure |
Brief Advice
n=28 Participants
Advice and education
|
MI-CBT
n=19 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Intake
|
27 percentage of days
Standard Deviation 29
|
40 percentage of days
Standard Deviation 45
|
|
Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Delivery
|
10 percentage of days
Standard Deviation 25
|
13 percentage of days
Standard Deviation 28
|
PRIMARY outcome
Timeframe: Delivery to 3 months post-deliveryPopulation: All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.
Outcome measures
| Measure |
Brief Advice
n=28 Participants
Advice and education
|
MI-CBT
n=18 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Delivery
|
10 percentage of days
Standard Deviation 25
|
13 percentage of days
Standard Deviation 28
|
|
Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
3 months post-delivery
|
18 percentage of days
Standard Deviation 32
|
8 percentage of days
Standard Deviation 8
|
SECONDARY outcome
Timeframe: At deliveryPopulation: 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.
Outcome measures
| Measure |
Brief Advice
n=84 Participants
Advice and education
|
MI-CBT
n=79 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Incidence of Preterm Births
|
17 preterm births
|
8 preterm births
|
SECONDARY outcome
Timeframe: At deliveryPopulation: 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.
Outcome measures
| Measure |
Brief Advice
n=84 Participants
Advice and education
|
MI-CBT
n=76 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Incidence of Low Birth Weight
|
17 low weight births
|
11 low weight births
|
SECONDARY outcome
Timeframe: intake to delivery, an average of 21 weeksPopulation: All randomized participants
Outcome measures
| Measure |
Brief Advice
n=86 Participants
Advice and education
|
MI-CBT
n=82 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Intake
|
0.41 proportion of participants
|
0.49 proportion of participants
|
|
Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Delivery
|
0.75 proportion of participants
|
0.76 proportion of participants
|
SECONDARY outcome
Timeframe: Delivery to 3 months post-deliveryPopulation: All randomized participants with data available from the time frame.
Outcome measures
| Measure |
Brief Advice
n=83 Participants
Advice and education
|
MI-CBT
n=80 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Delivery
|
0.75 proportion of participants
|
0.76 proportion of participants
|
|
Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
3 months post-delivery
|
0.38 proportion of participants
|
0.41 proportion of participants
|
SECONDARY outcome
Timeframe: intake to delivery, an average of 21 weeksPopulation: All randomized participants for whom urine test data was available.
Outcome measures
| Measure |
Brief Advice
n=80 Participants
Advice and education
|
MI-CBT
n=81 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine
Intake
|
0.54 proportion of participants
|
0.56 proportion of participants
|
|
Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine
Delivery
|
0.84 proportion of participants
|
0.84 proportion of participants
|
SECONDARY outcome
Timeframe: Delivery to 3 months post-deliveryPopulation: All randomized participants for whom urine data was available during the time frame.
Based on urine tests for marijuana, cocaine, or opioids
Outcome measures
| Measure |
Brief Advice
n=51 Participants
Advice and education
|
MI-CBT
n=55 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Proportion of Participants Abstinent From Drugs According to Urine
Delivery
|
0.84 proportion of participants
|
0.84 proportion of participants
|
|
Proportion of Participants Abstinent From Drugs According to Urine
3 months post-delivery
|
0.52 proportion of participants
|
0.59 proportion of participants
|
SECONDARY outcome
Timeframe: intake to delivery, an average of 21 weeksPopulation: All randomized participants with both self-report and urine data available.
Based on urine tests for marijuana, cocaine or opioids.
Outcome measures
| Measure |
Brief Advice
n=80 Participants
Advice and education
|
MI-CBT
n=81 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Intake
|
0.33 proportion of participants
|
0.43 proportion of participants
|
|
Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Delivery
|
0.76 proportion of participants
|
0.75 proportion of participants
|
SECONDARY outcome
Timeframe: Delivery to 3 months post-deliveryPopulation: All randomized participants with both self-report and urine data available during the time frame.
Based on urine tests for marijuana, cocaine, or opioids.
Outcome measures
| Measure |
Brief Advice
n=51 Participants
Advice and education
|
MI-CBT
n=55 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Delivery
|
0.76 proportion of participants
|
0.75 proportion of participants
|
|
Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
3 months post-delivery
|
0.34 proportion of participants
|
0.33 proportion of participants
|
SECONDARY outcome
Timeframe: intake to delivery, an average of 21 weeksPopulation: All randomized participants without a baseline diagnosis of drug abuse or dependence.
Outcome measures
| Measure |
Brief Advice
n=58 Participants
Advice and education
|
MI-CBT
n=63 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
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
|
0.50 proportion of participants
|
0.52 proportion of participants
|
|
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
|
0.76 proportion of participants
|
0.81 proportion of participants
|
SECONDARY outcome
Timeframe: Delivery to 3 months post-deliveryPopulation: All randomized participants without a baseline diagnosis of drug abuse or dependence with data available for the time frame.
Outcome measures
| Measure |
Brief Advice
n=55 Participants
Advice and education
|
MI-CBT
n=62 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
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
3 months post-delivery
|
0.28 proportion of participants
|
0.44 proportion of participants
|
|
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
|
0.76 proportion of participants
|
0.81 proportion of participants
|
SECONDARY outcome
Timeframe: intake to delivery, an average of 21 weeksPopulation: All randomized participants with a baseline diagnosis of drug abuse or dependence.
Outcome measures
| Measure |
Brief Advice
n=28 Participants
Advice and education
|
MI-CBT
n=19 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
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
|
0.21 proportion of participants
|
0.37 proportion of participants
|
|
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
|
0.71 proportion of participants
|
0.61 proportion of participants
|
SECONDARY outcome
Timeframe: Delivery to 3 months post-deliveryPopulation: All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.
Outcome measures
| Measure |
Brief Advice
n=28 Participants
Advice and education
|
MI-CBT
n=18 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
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
3 months post-delivery
|
0.54 proportion of participants
|
0.31 proportion of participants
|
|
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
|
0.71 proportion of participants
|
0.61 proportion of participants
|
SECONDARY outcome
Timeframe: intake to delivery, an average of 21 weeksPopulation: All randomized participants without a baseline diagnosis for drug abuse or dependence and with urine data.
Based on urine tests for marijuana, cocaine or opioids.
Outcome measures
| Measure |
Brief Advice
n=52 Participants
Advice and education
|
MI-CBT
n=62 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Intake
|
0.56 proportion of participants
|
0.60 proportion of participants
|
|
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Delivery
|
0.82 proportion of participants
|
0.85 proportion of participants
|
SECONDARY outcome
Timeframe: Delivery to 3 months post-deliveryPopulation: All randomized participants without a baseline diagnosis of drug abuse or dependence and urine data during the time frame.
Based on urine tests for marijuana, cocaine or opioids.
Outcome measures
| Measure |
Brief Advice
n=33 Participants
Advice and education
|
MI-CBT
n=46 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Delivery
|
0.82 proportion of participants
|
0.85 proportion of participants
|
|
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
3 months post-delivery
|
0.46 proportion of participants
|
0.58 proportion of participants
|
SECONDARY outcome
Timeframe: intake to delivery, an average of 21 weeksPopulation: All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.
Based on urine tests for marijuana, cocaine or opioids.
Outcome measures
| Measure |
Brief Advice
n=28 Participants
Advice and education
|
MI-CBT
n=19 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Intake
|
0.50 proportion of participants
|
0.42 proportion of participants
|
|
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Delivery
|
0.89 proportion of participants
|
0.78 proportion of participants
|
SECONDARY outcome
Timeframe: Delivery to 3 months post-deliveryPopulation: All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.
Based on urine tests for marijuana, cocaine or opioids.
Outcome measures
| Measure |
Brief Advice
n=18 Participants
Advice and education
|
MI-CBT
n=9 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Delivery
|
0.89 proportion of participants
|
0.78 proportion of participants
|
|
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
3 months post-delivery
|
0.60 proportion of participants
|
0.63 proportion of participants
|
SECONDARY outcome
Timeframe: intake to delivery, an average of 21 weeksPopulation: All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data.
Based on urine tests for marijuana, cocaine or opioids.
Outcome measures
| Measure |
Brief Advice
n=52 Participants
Advice and education
|
MI-CBT
n=62 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
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
Intake
|
0.42 proportion of participants
|
0.47 proportion of participants
|
|
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
|
0.76 proportion of participants
|
0.76 proportion of participants
|
SECONDARY outcome
Timeframe: Delivery to 3 months post-deliveryPopulation: All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.
Based on urine tests for marijuana, cocaine or opioids
Outcome measures
| Measure |
Brief Advice
n=33 Participants
Advice and education
|
MI-CBT
n=46 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
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
3 months post-delivery
|
0.23 proportion of participants
|
0.35 proportion of participants
|
|
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
|
0.76 proportion of participants
|
0.76 proportion of participants
|
SECONDARY outcome
Timeframe: intake to delivery, an average of 21 weeksPopulation: All randomized participants with a baseline diagnosis for drug abuse or dependence, and with both self-report and urine data.
Based on urine tests for marijuana, cocaine or opioids
Outcome measures
| Measure |
Brief Advice
n=28 Participants
Advice and education
|
MI-CBT
n=19 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
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
Intake
|
0.14 proportion of participants
|
0.32 proportion of participants
|
|
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
|
0.78 proportion of participants
|
0.67 proportion of participants
|
SECONDARY outcome
Timeframe: Delivery to 3 months post-deliveryPopulation: All randomized participants with a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame.
Based on urine tests for marijuana, cocaine or opioids
Outcome measures
| Measure |
Brief Advice
n=18 Participants
Advice and education
|
MI-CBT
n=9 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
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
|
0.78 proportion of participants
|
0.67 proportion of participants
|
|
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
3 months post-delivery
|
0.52 proportion of participants
|
0.25 proportion of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After prenatal care initiationPopulation: All randomized participants, 6 women had unkown attendance.
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.
Outcome measures
| Measure |
Brief Advice
n=86 Participants
Advice and education
|
MI-CBT
n=82 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Adequacy of Received Services
Inadequate (0-49% attendance)
|
2 participants
|
2 participants
|
|
Adequacy of Received Services
Intermediate (50%-79% attendance)
|
7 participants
|
13 participants
|
|
Adequacy of Received Services
Adequate (80%-109% attendance)
|
24 participants
|
33 participants
|
|
Adequacy of Received Services
Adequate plus (110+%)
|
51 participants
|
30 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days prior to assessmentPopulation: all randomized participants with data availabe at time frames
The number of patients who attended outside treatment in the 30 days prior to each assessment.
Outcome measures
| Measure |
Brief Advice
n=86 Participants
Advice and education
|
MI-CBT
n=82 Participants
Motivationally-enhanced cognitive behavioral skills counseling
|
|---|---|---|
|
Attendance of Treatment Outside the Study
Participants who attended prior to delivery
|
4 participants
|
6 participants
|
|
Attendance of Treatment Outside the Study
Participants who attended prior to 3 months post
|
9 participants
|
6 participants
|
Adverse Events
Brief Advice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MI-CBT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place