Facilitating Treatment Entry and Family Planning in Substance-using Neonatal Intensive Care Unit (NICU) Mothers
2020年11月17日 更新者：Angela L Stotts、The University of Texas Health Science Center, Houston
Facilitating Treatment Entry and Family Planning in Substance-using NICU Mothers
The purpose of this pilot study is to assess whether the hospital-based, adaptive behavioral intervention strategy promotes treatment entry and reduces risk of additional substance-exposed pregnancies (SEPs), as well as HIV and Hepatitis C Virus (HCV) risks among substance-using NICU mothers.
Additionally, to assess whether the intervention increases use of professional obstetrical/gynecological resources for contraception to reduce substance-exposed pregnancies (SEPs).
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
64
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Texas
-
Houston、Texas、美国、77030
- The University of Texas Health Science Center at Houston
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- have an infant in the NICU at Children's Memorial Hermann Hospital (CMHH)
- have a positive urine drug screen at delivery or have an infant with a positive urine or meconium drug screen or self-reported drug use to a healthcare provider or had a documented positive drug screen during pregnancy
- have access to a telephone.
Exclusion Criteria:
- currently attending substance abuse treatment
- severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol
- inability to read, write, speak English or Spanish
- inability or unwillingness to provide signed consent for participation; (5) inability or unwillingness to meet study requirements.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：MI and ACT
Participants will receive behavioral therapy including Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
|
Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
|
|
有源比较器：Conventional Care
Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers.
|
Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment Entry
大体时间：8 weeks
|
Number of participants having at least one treatment session at a licensed substance use facility or with a licensed counselor
|
8 weeks
|
|
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
大体时间：2 months
|
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
|
2 months
|
|
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
大体时间：6 months
|
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
|
6 months
|
|
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
大体时间：2 months
|
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
|
2 months
|
|
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
大体时间：6 months
|
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
大体时间：2 months
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
|
2 months
|
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
大体时间：6 months
|
Depression as assessed by the Center for Epidemiologic Studies Depression Scale (CES-D)
|
6 months
|
|
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
大体时间：2 months
|
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
|
2 months
|
|
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
大体时间：6 months
|
Current position regarding motivation for change as assessed by the University of Rhode Island Change Assessment (URICA)
|
6 months
|
|
Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
大体时间：2 months
|
This self-report measure of psychological flexibility will assess a participant's willingness to have undesirable thoughts and feelings related to drug use while still pursuing self-identified goals.
This version of the AAQ was specifically developed for substance-abusing populations.
|
2 months
|
|
Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)
大体时间：6 months
|
This self-report measure of psychological flexibility will assess a participant's willingness to have undesirable thoughts and feelings related to drug use while still pursuing self-identified goals.
This version of the AAQ was specifically developed for substance-abusing populations.
|
6 months
|
|
Number of participants whose infant had routine follow-up pediatric appointments
大体时间：6 months
|
Medical records will be used, with participant consent, to assess the number of participants whose infant had routine follow-up pediatric appointments.
|
6 months
|
|
Number of participants whose infant had acute care visits
大体时间：6 months
|
Medical records will be used, with participant consent, to assess the number of participants whose infant had acute care visits.
|
6 months
|
|
Number of participants whose infant had emergency department visits
大体时间：6 months
|
Medical records will be used, with participant consent, to assess the number of participants whose infant had emergency department visits.
|
6 months
|
|
Number of participants whose infant was re-hospitalized
大体时间：6 months
|
Medical records will be used, with participant consent, to assess the number of participants whose infant was re-hospitalized.
|
6 months
|
|
Number of participants who lost custody of the infant
大体时间：6 months
|
Medical records will be used, with participant consent, and additionally the research team will collaborate with the NICU social worker and the assigned child protective services (CPS) caseworker, with participant consent, to obtain information about the number of participants who lost custody of the infant.
|
6 months
|
|
Number of participants for which any additional abuse or neglect complaints were filed after baseline
大体时间：6 months
|
Medical records will be used, with participant consent, and additionally the research team will collaborate with the NICU social worker and the assigned child protective services (CPS) caseworker, with participant consent, to obtain information about the number of participants for which any additional abuse or neglect complaints were filed after baseline.
|
6 months
|
|
Drug use
大体时间：2 months
|
Number of participant who test positive for drug use as assessed by urine drug screen
|
2 months
|
|
Drug use
大体时间：6 months
|
Number of participant who test positive for drug use as assessed by urine drug screen
|
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Angela Stotts, PhD、The University of Texas Health Science Center, Houston
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年7月5日
初级完成 (实际的)
2020年1月3日
研究完成 (实际的)
2020年1月3日
研究注册日期
首次提交
2017年5月23日
首先提交符合 QC 标准的
2017年5月23日
首次发布 (实际的)
2017年5月24日
研究记录更新
最后更新发布 (实际的)
2020年11月19日
上次提交的符合 QC 标准的更新
2020年11月17日
最后验证
2020年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.