Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DA019135 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MI-CBT | Experimental | Motivationally-enhanced cognitive behavioral skills counseling |
|
| Brief Advice | Active Comparator | Advice and education |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MI-CBT | Behavioral | Motivationally-enhanced cognitive behavioral skills counseling |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Days Used Drugs or Alcohol | intake to delivery, an average of 21 weeks | |
| Percentage of Days Used Drugs or Alcohol | delivery to 3 months post-delivery | |
| 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 (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | Delivery to 3 months post-delivery | |
| 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 That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | Delivery to 3 months post-delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Preterm Births | At delivery | |
| Incidence of Low Birth Weight | At delivery | |
| Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report |
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of Received Services | Based on prenatal care attendance: the percent of visits attended after prenatal care initiation, accounting for time of delivery. Attendance was rated according to the Kotelchuck Adequacy of Prenatal Care Index. Only the normally scheduled prenatal car visits were included. | After prenatal care initiation |
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.
-
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kimberly A Yonkers, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridgeport Hospital | Bridgeport | Connecticut | 06106 | United States | ||
| Yale-New Haven Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19350369 | Background | Yonkers KA, Howell HB, Allen AE, Ball SA, Pantalon MV, Rounsaville BJ. A treatment for substance abusing pregnant women. Arch Womens Ment Health. 2009 Aug;12(4):221-7. doi: 10.1007/s00737-009-0069-2. Epub 2009 Apr 7. | |
| 18956504 | Background | Hine CE, Howell HB, Yonkers KA. Integration of medical and psychological treatment within the primary health care setting. Soc Work Health Care. 2008;47(2):122-34. doi: 10.1080/00981380801970244. |
Not provided
Not provided
only aggregate de-identified data
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Brief Advice | Advice and education |
| FG001 | MI-CBT | Motivationally-enhanced cognitive behavioral skills counseling |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis excluded women with no follow-up assessments.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Brief Advice | Advice and education |
| BG001 | MI-CBT | Motivationally-enhanced cognitive behavioral skills counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Days Used Drugs or Alcohol | all randomized participants | Posted | Mean | Standard Deviation | percentage of days | intake to delivery, an average of 21 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brief Advice | Advice and education |
Not provided
Not provided
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kimberly Yonkers | Yale University | 1-203-764-6621 | Kimberly.Yonkers@yale.edu |
Not provided
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D019970 | Cocaine-Related Disorders |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Brief Advice |
| Behavioral |
Advice and education |
|
| intake to delivery, an average of 21 weeks |
| Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | Delivery to 3 months post-delivery |
| 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 | Based on urine tests for marijuana, cocaine, or opioids | Delivery to 3 months post-delivery |
| Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine or opioids. | intake to delivery, an average of 21 weeks |
| Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine, or opioids. | Delivery to 3 months post-delivery |
| 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 |
| Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | Delivery to 3 months post-delivery |
| 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 (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | Delivery to 3 months post-delivery |
| Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Based on urine tests for marijuana, cocaine or opioids. | intake to delivery, an average of 21 weeks |
| Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Based on urine tests for marijuana, cocaine or opioids. | Delivery to 3 months post-delivery |
| Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Based on urine tests for marijuana, cocaine or opioids. | intake to delivery, an average of 21 weeks |
| Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Based on urine tests for marijuana, cocaine or opioids. | Delivery to 3 months post-delivery |
| Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine or opioids. | intake to delivery, an average of 21 weeks |
| Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine or opioids | Delivery to 3 months post-delivery |
| Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine or opioids | intake to delivery, an average of 21 weeks |
| Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine or opioids | Delivery to 3 months post-delivery |
| Attendance of Treatment Outside the Study |
The number of patients who attended outside treatment in the 30 days prior to each assessment. |
| 30 days prior to assessment |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| 20859145 | Background | Yonkers KA, Gotman N, Kershaw T, Forray A, Howell HB, Rounsaville BJ. Screening for prenatal substance use: development of the Substance Use Risk Profile-Pregnancy scale. Obstet Gynecol. 2010 Oct;116(4):827-833. doi: 10.1097/AOG.0b013e3181ed8290. |
| 22489543 | Background | Quesada O, Gotman N, Howell HB, Funai EF, Rounsaville BJ, Yonkers KA. Prenatal hazardous substance use and adverse birth outcomes. J Matern Fetal Neonatal Med. 2012 Aug;25(8):1222-7. doi: 10.3109/14767058.2011.602143. Epub 2012 May 11. |
| 22795046 | Result | Yonkers KA, Forray A, Howell HB, Gotman N, Kershaw T, Rounsaville BJ, Carroll KM. Motivational enhancement therapy coupled with cognitive behavioral therapy versus brief advice: a randomized trial for treatment of hazardous substance use in pregnancy and after delivery. Gen Hosp Psychiatry. 2012 Sep-Oct;34(5):439-49. doi: 10.1016/j.genhosppsych.2012.06.002. Epub 2012 Jul 12. |
| 28270105 | Derived | Xu X, Yonkers KA, Ruger JP. Economic evaluation of a behavioral intervention versus brief advice for substance use treatment in pregnant women: results from a randomized controlled trial. BMC Pregnancy Childbirth. 2017 Mar 7;17(1):83. doi: 10.1186/s12884-017-1260-5. |
| 24447885 | Derived | Forray A, Gotman N, Kershaw T, Yonkers KA. Perinatal smoking and depression in women with concurrent substance use. Addict Behav. 2014 Apr;39(4):749-56. doi: 10.1016/j.addbeh.2013.12.008. Epub 2013 Dec 17. |
| Lost to Follow-up |
|
| Miscarriage |
|
| BG002 |
| Total |
Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 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. | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Education (years) | Number | participants |
|
| Parity | Parity defined as number of previous births | Count of Participants | Participants |
|
| Gestational age at intake | Number | participants |
|
| Prenatal care initiation | Number | participants |
|
| Site | Number | participants |
|
| MINI drug or alcohol abuse or dependence | Number | participants |
|
| Past-month use | 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. | Number | participants |
|
| Primary Drug | 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. | Number | participants |
|
|
|
|
| Secondary | Incidence of Preterm Births | 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. | Posted | Number | preterm births | At delivery |
|
|
|
|
| Primary | Percentage of Days Used Drugs or Alcohol | all randomized participants with data from delivery and 3 months post-delivery | Posted | Mean | Standard Deviation | percentage of days | delivery to 3 months post-delivery |
|
|
|
|
| Secondary | Incidence of Low Birth Weight | 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. | Posted | Number | low weight births | At delivery |
|
|
|
|
| Secondary | Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | All randomized participants | Posted | Number | proportion of participants | intake to delivery, an average of 21 weeks |
|
|
|
|
| Secondary | Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | All randomized participants with data available from the time frame. | Posted | Number | proportion of participants | Delivery to 3 months post-delivery |
|
|
|
|
| Secondary | Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine | All randomized participants for whom urine test data was available. | Posted | Number | proportion of participants | intake to delivery, an average of 21 weeks |
|
|
|
|
| Secondary | Proportion of Participants Abstinent From Drugs According to Urine | Based on urine tests for marijuana, cocaine, or opioids | All randomized participants for whom urine data was available during the time frame. | Posted | Number | proportion of participants | Delivery to 3 months post-delivery |
|
|
|
|
| Secondary | Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine or opioids. | All randomized participants with both self-report and urine data available. | Posted | Number | proportion of participants | intake to delivery, an average of 21 weeks |
|
|
|
|
| Primary | Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | All randomized participants without a baseline diagnosis of drug use or dependence. | Posted | Mean | Standard Deviation | percentage of days | intake to delivery, an average of 21 weeks |
|
|
|
|
| Primary | Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | All randomized participants without a baseline diagnosis for drug abuse or dependence with data available for time frame. | Posted | Mean | Standard Deviation | percentage of days | Delivery to 3 months post-delivery |
|
|
|
|
| Primary | Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | All randomized participants with a baseline diagnosis for drug abuse or dependence. | Posted | Mean | Standard Deviation | percentage of days | intake to delivery, an average of 21 weeks |
|
|
|
|
| Primary | Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol | All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame. | Posted | Mean | Standard Deviation | percentage of days | Delivery to 3 months post-delivery |
|
|
|
|
| Secondary | Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine, or opioids. | All randomized participants with both self-report and urine data available during the time frame. | Posted | Number | proportion of participants | Delivery to 3 months post-delivery |
|
|
|
|
| Secondary | Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | All randomized participants without a baseline diagnosis of drug abuse or dependence. | Posted | Number | proportion of participants | intake to delivery, an average of 21 weeks |
|
|
|
|
| Secondary | Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | All randomized participants without a baseline diagnosis of drug abuse or dependence with data available for the time frame. | Posted | Number | proportion of participants | Delivery to 3 months post-delivery |
|
|
|
|
| Secondary | Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | All randomized participants with a baseline diagnosis of drug abuse or dependence. | Posted | Number | proportion of participants | intake to delivery, an average of 21 weeks |
|
|
|
|
| Secondary | Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report | All randomized participants with a baseline diagnosis of drug abuse or dependence and data available for the time frame. | Posted | Number | proportion of participants | Delivery to 3 months post-delivery |
|
|
|
|
| Secondary | Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Based on urine tests for marijuana, cocaine or opioids. | All randomized participants without a baseline diagnosis for drug abuse or dependence and with urine data. | Posted | Number | proportion of participants | intake to delivery, an average of 21 weeks |
|
|
|
|
| Secondary | Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Based on urine tests for marijuana, cocaine or opioids. | All randomized participants without a baseline diagnosis of drug abuse or dependence and urine data during the time frame. | Posted | Number | proportion of participants | Delivery to 3 months post-delivery |
|
|
|
|
| Secondary | Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Based on urine tests for marijuana, cocaine or opioids. | All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data. | Posted | Number | proportion of participants | intake to delivery, an average of 21 weeks |
|
|
|
|
| Secondary | Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Based on urine tests for marijuana, cocaine or opioids. | All randomized participants with a baseline diagnosis of drug abuse or dependence and urine data. | Posted | Number | proportion of participants | Delivery to 3 months post-delivery |
|
|
|
|
| Secondary | Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine or opioids. | All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data. | Posted | Number | proportion of participants | intake to delivery, an average of 21 weeks |
|
|
|
|
| Secondary | Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine or opioids | All randomized participants without a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame. | Posted | Number | proportion of participants | Delivery to 3 months post-delivery |
|
|
|
|
| Secondary | Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine or opioids | All randomized participants with a baseline diagnosis for drug abuse or dependence, and with both self-report and urine data. | Posted | Number | proportion of participants | intake to delivery, an average of 21 weeks |
|
|
|
|
| Secondary | Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine or opioids | All randomized participants with a baseline diagnosis of drug abuse or dependence, and with both self-report and urine data for the time frame. | Posted | Number | proportion of participants | Delivery to 3 months post-delivery |
|
|
|
|
| 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. | All randomized participants, 6 women had unkown attendance. | Posted | Number | participants | After prenatal care initiation |
|
|
|
|
| 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. | all randomized participants with data availabe at time frames | Posted | Number | participants | 30 days prior to assessment |
|
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | MI-CBT | Motivationally-enhanced cognitive behavioral skills counseling | 0 | 82 | 0 | 82 |
Not provided
Not provided
| Adequate (80%-109% attendance) |
|
| Adequate plus (110+%) |
|