Therapeutic Substance Abuse Treatment in Pregnancy - 1
关键词
抽象
描述
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.
日期
| 最后验证: | 03/31/2020 |
| 首次提交: | 09/26/2005 |
| 提交的预估入学人数: | 09/26/2005 |
| 首次发布: | 09/27/2005 |
| 上次提交的更新: | 03/31/2020 |
| 最近更新发布: | 04/14/2020 |
| 首次提交结果的日期: | 06/13/2013 |
| 首次提交质量检查结果的日期: | 06/13/2013 |
| 首次发布结果的日期: | 08/20/2013 |
| 实际学习开始日期: | 08/31/2004 |
| 预计主要完成日期: | 07/31/2010 |
| 预计完成日期: | 07/31/2010 |
状况或疾病
干预/治疗
Behavioral: MI-CBT
Behavioral: Brief Advice
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: MI-CBT Motivationally-enhanced cognitive behavioral skills counseling | Behavioral: MI-CBT Motivationally-enhanced cognitive behavioral skills counseling |
| Active Comparator: Brief Advice Advice and education | Behavioral: Brief Advice Advice and education |
资格标准
| 有资格学习的年龄 | 16 Years 至 16 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | 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. - |
结果
主要结果指标
1. Percentage of Days Used Drugs or Alcohol [intake to delivery, an average of 21 weeks]
2. Percentage of Days Used Drugs or Alcohol [delivery to 3 months post-delivery]
3. Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [intake to delivery, an average of 21 weeks]
4. Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [Delivery to 3 months post-delivery]
5. Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [intake to delivery, an average of 21 weeks]
6. Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [Delivery to 3 months post-delivery]
次要成果指标
1. Incidence of Preterm Births [At delivery]
2. Incidence of Low Birth Weight [At delivery]
3. 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]
4. Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [Delivery to 3 months post-delivery]
5. Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine [intake to delivery, an average of 21 weeks]
6. Proportion of Participants Abstinent From Drugs According to Urine [Delivery to 3 months post-delivery]
7. Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [intake to delivery, an average of 21 weeks]
8. Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [Delivery to 3 months post-delivery]
9. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [intake to delivery, an average of 21 weeks]
10. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [Delivery to 3 months post-delivery]
11. Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [intake to delivery, an average of 21 weeks]
12. Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [Delivery to 3 months post-delivery]
13. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [intake to delivery, an average of 21 weeks]
14. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [Delivery to 3 months post-delivery]
15. 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]
16. Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [Delivery to 3 months post-delivery]
17. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [intake to delivery, an average of 21 weeks]
18. Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [Delivery to 3 months post-delivery]
19. Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [intake to delivery, an average of 21 weeks]
20. Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [Delivery to 3 months post-delivery]
其他成果措施
1. Adequacy of Received Services [After prenatal care initiation]
2. Attendance of Treatment Outside the Study [30 days prior to assessment]
