Alcohol Abuse, Cocaine Abuse, Marijuana Abuse
Conditions
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).
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.
Interventions
BEHAVIORALMI-CBT
Motivationally-enhanced cognitive behavioral skills counseling
BEHAVIORALBrief Advice
Advice and education
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Percentage of Days Used Drugs or Alcohol | intake to delivery, an average of 21 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine | intake to delivery, an average of 21 weeks | — |
| Proportion of Participants Abstinent From Drugs According to Urine | Delivery to 3 months post-delivery | Based on urine tests for marijuana, cocaine, or opioids |
| Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | intake to delivery, an average of 21 weeks | Based on urine tests for marijuana, cocaine or opioids. |
| 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 | — |
| Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | intake to delivery, an average of 21 weeks | Based on urine tests for marijuana, cocaine or opioids. |
| Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | intake to delivery, an average of 21 weeks | Based on urine tests for marijuana, cocaine or opioids. |
| 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 to delivery, an average of 21 weeks | Based on urine tests for marijuana, cocaine or opioids. |
| 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 to delivery, an average of 21 weeks | Based on urine tests for marijuana, cocaine or opioids |
| 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 | — |
| Incidence of Preterm Births | At delivery | — |
| Incidence of Low Birth Weight | At delivery | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adequacy of Received Services | 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. |
| Attendance of Treatment Outside the Study | 30 days prior to assessment | The number of patients who attended outside treatment in the 30 days prior to each assessment. |
Countries
United States
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| Brief Advice Advice and education | 86 |
| MI-CBT Motivationally-enhanced cognitive behavioral skills counseling | 82 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Miscarriage | 1 | 0 |
| Overall Study | Subject moved out of area | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | Brief Advice | MI-CBT | Total |
|---|---|---|---|
| Age, Customized 20-34 years | 65 participants | 61 participants | 126 participants |
| Age, Customized <20 years | 13 participants | 16 participants | 29 participants |
| Age, Customized >35 years | 8 participants | 5 participants | 13 participants |
| Education (years) 12 | 31 participants | 35 participants | 66 participants |
| Education (years) <12 | 26 participants | 32 participants | 58 participants |
| Education (years) 13-15 | 23 participants | 14 participants | 37 participants |
| Education (years) 16+ | 6 participants | 1 participants | 7 participants |
| Gestational age at intake Weeks 17-24 | 31 participants | 27 participants | 58 participants |
| Gestational age at intake Weeks 1-8 | 5 participants | 3 participants | 8 participants |
| Gestational age at intake Weeks 25 or later | 25 participants | 24 participants | 49 participants |
| Gestational age at intake Weeks 9-16 | 25 participants | 28 participants | 53 participants |
| MINI drug or alcohol abuse or dependence Participants diagnosed with abuse or dependence | 28 participants | 19 participants | 47 participants |
| MINI drug or alcohol abuse or dependence Participants without such a diagnosis | 58 participants | 63 participants | 121 participants |
| Parity 0 | 35 Participants | 31 Participants | 66 Participants |
| Parity 1 | 27 Participants | 25 Participants | 52 Participants |
| Parity 2+ | 24 Participants | 26 Participants | 50 Participants |
| Past-month use Alcohol (any) | 33 participants | 19 participants | 52 participants |
| Past-month use Alcohol (intoxication) | 7 participants | 9 participants | 16 participants |
| Past-month use Amphetamines | 1 participants | 0 participants | 1 participants |
| Past-month use Barbiturates | 0 participants | 0 participants | 0 participants |
| Past-month use Cocaine | 11 participants | 7 participants | 18 participants |
| Past-month use Hallucinogens | 2 participants | 1 participants | 3 participants |
| Past-month use Heroin | 1 participants | 3 participants | 4 participants |
| Past-month use Inhalants | 0 participants | 0 participants | 0 participants |
| Past-month use Marijuana | 40 participants | 34 participants | 74 participants |
| Past-month use Methadone | 5 participants | 8 participants | 13 participants |
| Past-month use Opiates (excluding methadone) | 6 participants | 4 participants | 10 participants |
| Past-month use Sedatives | 5 participants | 1 participants | 6 participants |
| Prenatal care initiation Unknown | 1 participants | 4 participants | 5 participants |
| Prenatal care initiation Week 25 or later | 4 participants | 5 participants | 9 participants |
| Prenatal care initiation Weeks 17-24 | 13 participants | 10 participants | 23 participants |
| Prenatal care initiation Weeks 1-8 | 21 participants | 23 participants | 44 participants |
| Prenatal care initiation Weeks 9-16 | 47 participants | 40 participants | 87 participants |
| Primary Drug Alcohol | 25 participants | 26 participants | 51 participants |
| Primary Drug Cocaine | 15 participants | 14 participants | 29 participants |
| Primary Drug Marijuana | 40 participants | 37 participants | 77 participants |
| Primary Drug Other | 6 participants | 5 participants | 11 participants |
| Race/Ethnicity, Customized Black | 47 participants | 42 participants | 89 participants |
| Race/Ethnicity, Customized Hispanic | 24 participants | 19 participants | 43 participants |
| Race/Ethnicity, Customized Other | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized White | 17 participants | 19 participants | 36 participants |
| Region of Enrollment United States | 86 participants | 82 participants | 168 participants |
| Sex: Female, Male Female | 86 Participants | 82 Participants | 168 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Site Bridgeport Hospital | 22 participants | 25 participants | 47 participants |
| Site Yale New Haven Hospital | 64 participants | 57 participants | 121 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 86 | 0 / 82 |
| serious Total, serious adverse events | 0 / 86 | 0 / 82 |
Outcome results
Primary
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
Population: All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Advice | 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 |
| Brief Advice | 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 |
| MI-CBT | Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | Delivery | 13 percentage of days | Standard Deviation 28 |
| MI-CBT | Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | 3 months post-delivery | 8 percentage of days | Standard Deviation 8 |
p-value: 0.1Mixed Models Analysis
Primary
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
Population: All randomized participants with a baseline diagnosis for drug abuse or dependence.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Advice | 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 |
| Brief Advice | 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 |
| MI-CBT | Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | Intake | 40 percentage of days | Standard Deviation 45 |
| MI-CBT | Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | Delivery | 13 percentage of days | Standard Deviation 28 |
p-value: 0.1Mixed Models Analysis
Primary
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
Population: All randomized participants without a baseline diagnosis for drug abuse or dependence with data available for time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Advice | 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 |
| Brief Advice | 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 |
| MI-CBT | Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | Delivery | 6 percentage of days | Standard Deviation 20 |
| MI-CBT | Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | 3 months post-delivery | 14 percentage of days | Standard Deviation 27 |
p-value: 0.1Mixed Models Analysis
Primary
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
Population: All randomized participants without a baseline diagnosis of drug use or dependence.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Advice | 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 |
| Brief Advice | 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 |
| MI-CBT | Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | Intake | 15 percentage of days | Standard Deviation 27 |
| MI-CBT | Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | Delivery | 6 percentage of days | Standard Deviation 20 |
p-value: 0.1Mixed Models Analysis
Primary
Percentage of Days Used Drugs or Alcohol
Time frame: intake to delivery, an average of 21 weeks
Population: all randomized participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Advice | Percentage of Days Used Drugs or Alcohol | Intake | 18 percentage of days | Standard Deviation 27 |
| Brief Advice | Percentage of Days Used Drugs or Alcohol | Delivery | 6 percentage of days | Standard Deviation 17 |
| MI-CBT | Percentage of Days Used Drugs or Alcohol | Intake | 21 percentage of days | Standard Deviation 34 |
| MI-CBT | Percentage of Days Used Drugs or Alcohol | Delivery | 7 percentage of days | Standard Deviation 22 |
Comparison: We estimated that 110 people with 10% attrition would provide 80% powerp-value: 0.88Mixed Models Analysis
Primary
Percentage of Days Used Drugs or Alcohol
Time frame: delivery to 3 months post-delivery
Population: all randomized participants with data from delivery and 3 months post-delivery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brief Advice | Percentage of Days Used Drugs or Alcohol | Delivery | 6 percentage of days | Standard Deviation 17 |
| Brief Advice | Percentage of Days Used Drugs or Alcohol | 3 months post-delivery | 14 percentage of days | Standard Deviation 25 |
| MI-CBT | Percentage of Days Used Drugs or Alcohol | Delivery | 7 percentage of days | Standard Deviation 22 |
| MI-CBT | Percentage of Days Used Drugs or Alcohol | 3 months post-delivery | 13 percentage of days | Standard Deviation 24 |
Comparison: We estimated that 110 people with 10% attrition would provide 80% power.p-value: 0.88Mixed Models Analysis
Secondary
Incidence of Low Birth Weight
Time frame: At delivery
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Brief Advice | Incidence of Low Birth Weight | 17 low weight births |
| MI-CBT | Incidence of Low Birth Weight | 11 low weight births |
p-value: 0.41Fisher Exact
Secondary
Incidence of Preterm Births
Time frame: At delivery
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Brief Advice | Incidence of Preterm Births | 17 preterm births |
| MI-CBT | Incidence of Preterm Births | 8 preterm births |
p-value: 0.08Fisher Exact
Secondary
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
Population: All randomized participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | Intake | 0.41 proportion of participants |
| Brief Advice | Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | Delivery | 0.75 proportion of participants |
| MI-CBT | Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | Intake | 0.49 proportion of participants |
| MI-CBT | Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | Delivery | 0.76 proportion of participants |
p-value: 0.7995% CI: [0.36, 1.67]Regression, Logistic
Secondary
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
Population: All randomized participants with data available from the time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | Delivery | 0.75 proportion of participants |
| Brief Advice | 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 |
| MI-CBT | Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | Delivery | 0.76 proportion of participants |
| MI-CBT | Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | 3 months post-delivery | 0.41 proportion of participants |
p-value: 0.7995% CI: [0.42, 2.62]Regression, Logistic
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.
Time frame: intake to delivery, an average of 21 weeks
Population: All randomized participants with both self-report and urine data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Intake | 0.33 proportion of participants |
| Brief Advice | Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Delivery | 0.76 proportion of participants |
| MI-CBT | Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Intake | 0.43 proportion of participants |
| MI-CBT | Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Delivery | 0.75 proportion of participants |
p-value: 0.595% CI: [0.32, 1.84]Regression, Logistic
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.
Time frame: Delivery to 3 months post-delivery
Population: All randomized participants with both self-report and urine data available during the time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Delivery | 0.76 proportion of participants |
| Brief Advice | 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 |
| MI-CBT | Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Delivery | 0.75 proportion of participants |
| MI-CBT | Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | 3 months post-delivery | 0.33 proportion of participants |
p-value: 0.595% CI: [0.27, 2.11]Regression, Logistic
Secondary
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
Population: All randomized participants for whom urine data was available during the time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | Proportion of Participants Abstinent From Drugs According to Urine | Delivery | 0.84 proportion of participants |
| Brief Advice | Proportion of Participants Abstinent From Drugs According to Urine | 3 months post-delivery | 0.52 proportion of participants |
| MI-CBT | Proportion of Participants Abstinent From Drugs According to Urine | Delivery | 0.84 proportion of participants |
| MI-CBT | Proportion of Participants Abstinent From Drugs According to Urine | 3 months post-delivery | 0.59 proportion of participants |
p-value: 0.8895% CI: [0.57, 2.57]Regression, Logistic
Secondary
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
Population: All randomized participants for whom urine test data was available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine | Intake | 0.54 proportion of participants |
| Brief Advice | Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine | Delivery | 0.84 proportion of participants |
| MI-CBT | Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine | Intake | 0.56 proportion of participants |
| MI-CBT | Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine | Delivery | 0.84 proportion of participants |
p-value: 0.8895% CI: [0.34, 2.72]Regression, Logistic
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
Time frame: Delivery to 3 months post-delivery
Population: All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | 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 |
| Brief Advice | 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 |
| MI-CBT | 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 | 0.61 proportion of participants |
| MI-CBT | 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 | 0.31 proportion of participants |
p-value: 0.0795% CI: [0.1, 3.9]Regression, Logistic
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
Time frame: intake to delivery, an average of 21 weeks
Population: All randomized participants with a baseline diagnosis of drug abuse or dependence.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | 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 |
| Brief Advice | 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 |
| MI-CBT | 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 | 0.37 proportion of participants |
| MI-CBT | 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 | 0.61 proportion of participants |
p-value: 0.0795% CI: [0.08, 1.02]Regression, Logistic
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
Time frame: intake to delivery, an average of 21 weeks
Population: All randomized participants with a baseline diagnosis for drug abuse or dependence, and with both self-report and urine data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | 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 |
| Brief Advice | 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 |
| MI-CBT | 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 | 0.32 proportion of participants |
| MI-CBT | 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 | 0.67 proportion of participants |
p-value: 0.0495% CI: [0.04, 1.63]Regression, Logistic
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
Time frame: Delivery to 3 months post-delivery
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | 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 |
| Brief Advice | 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 |
| MI-CBT | 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 | 0.67 proportion of participants |
| MI-CBT | 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 | 0.25 proportion of participants |
p-value: 0.0495% CI: [0.04, 3.74]Regression, Logistic
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.
Time frame: intake to delivery, an average of 21 weeks
Population: All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Intake | 0.50 proportion of participants |
| Brief Advice | Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Delivery | 0.89 proportion of participants |
| MI-CBT | Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Intake | 0.42 proportion of participants |
| MI-CBT | Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Delivery | 0.78 proportion of participants |
p-value: 0.9195% CI: [0.14, 5.23]Regression, Logistic
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.
Time frame: Delivery to 3 months post-delivery
Population: All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Delivery | 0.89 proportion of participants |
| Brief Advice | 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 |
| MI-CBT | Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Delivery | 0.78 proportion of participants |
| MI-CBT | Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | 3 months post-delivery | 0.63 proportion of participants |
p-value: 0.9195% CI: [0.21, 7.12]Regression, Logistic
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
Time frame: intake to delivery, an average of 21 weeks
Population: All randomized participants without a baseline diagnosis of drug abuse or dependence.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | 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 |
| Brief Advice | 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 |
| MI-CBT | 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 | 0.52 proportion of participants |
| MI-CBT | 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 | 0.81 proportion of participants |
p-value: 0.0795% CI: [0.44, 3.14]Regression, Logistic
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
Time frame: Delivery to 3 months post-delivery
Population: All randomized participants without a baseline diagnosis of drug abuse or dependence with data available for the time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | 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 |
| Brief Advice | 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 |
| MI-CBT | 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 | 0.81 proportion of participants |
| MI-CBT | 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 | 0.44 proportion of participants |
p-value: 0.0795% CI: [0.47, 4.52]Regression, Logistic
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.
Time frame: intake to delivery, an average of 21 weeks
Population: All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | 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 |
| Brief Advice | 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 |
| MI-CBT | 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 |
| MI-CBT | 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 | 0.47 proportion of participants |
p-value: 0.0495% CI: [0.46, 3.55]Regression, Logistic
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
Time frame: Delivery to 3 months post-delivery
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | 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 |
| Brief Advice | 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 |
| MI-CBT | 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 |
| MI-CBT | 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 | 0.35 proportion of participants |
p-value: 0.0495% CI: [0.35, 4.17]Regression, Logistic
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.
Time frame: Delivery to 3 months post-delivery
Population: All randomized participants without a baseline diagnosis of drug abuse or dependence and urine data during the time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Delivery | 0.82 proportion of participants |
| Brief Advice | 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 |
| MI-CBT | Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Delivery | 0.85 proportion of participants |
| MI-CBT | Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | 3 months post-delivery | 0.58 proportion of participants |
p-value: 0.9195% CI: [0.35, 5.07]Regression, Logistic
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.
Time frame: intake to delivery, an average of 21 weeks
Population: All randomized participants without a baseline diagnosis for drug abuse or dependence and with urine data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Intake | 0.56 proportion of participants |
| Brief Advice | Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Delivery | 0.82 proportion of participants |
| MI-CBT | Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Intake | 0.60 proportion of participants |
| MI-CBT | Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Delivery | 0.85 proportion of participants |
p-value: 0.9195% CI: [0.32, 4.2]Regression, Logistic
Other Pre-specified
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.
Time frame: After prenatal care initiation
Population: All randomized participants, 6 women had unkown attendance.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | Adequacy of Received Services | Intermediate (50%-79% attendance) | 7 participants |
| Brief Advice | Adequacy of Received Services | Inadequate (0-49% attendance) | 2 participants |
| Brief Advice | Adequacy of Received Services | Adequate plus (110+%) | 51 participants |
| Brief Advice | Adequacy of Received Services | Adequate (80%-109% attendance) | 24 participants |
| MI-CBT | Adequacy of Received Services | Adequate plus (110+%) | 30 participants |
| MI-CBT | Adequacy of Received Services | Adequate (80%-109% attendance) | 33 participants |
| MI-CBT | Adequacy of Received Services | Inadequate (0-49% attendance) | 2 participants |
| MI-CBT | Adequacy of Received Services | Intermediate (50%-79% attendance) | 13 participants |
p-value: 0.01Cochran-Mantel-Haenszel
Other Pre-specified
Attendance of Treatment Outside the Study
The number of patients who attended outside treatment in the 30 days prior to each assessment.
Time frame: 30 days prior to assessment
Population: all randomized participants with data availabe at time frames
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brief Advice | Attendance of Treatment Outside the Study | Participants who attended prior to delivery | 4 participants |
| Brief Advice | Attendance of Treatment Outside the Study | Participants who attended prior to 3 months post | 9 participants |
| MI-CBT | Attendance of Treatment Outside the Study | Participants who attended prior to delivery | 6 participants |
| MI-CBT | Attendance of Treatment Outside the Study | Participants who attended prior to 3 months post | 6 participants |
p-value: >0.05Chi-squared