Facilitating Treatment Entry and Family Planning in Substance-using NICU Mothers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Treatment Entry
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Treatment Entry
时间窗: 8 weeks
Number of participants having at least one treatment session at a licensed substance use facility or with a licensed counselor
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
时间窗: 6 months
Substance Exposed Pregnancy (SEP) risk as as assessed by a modified Time-Line Follow Back-SEP (TLFB-SEP)
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
时间窗: 6 months
HIV and HCV risk as assessed by Behavioral Risk Assessment for Infectious Disease (BRAID)
次要结局
- 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)(6 months)
- Psychological flexibility as assessed by the Acceptance and Action Questionnaire-Substance Abuse (AAQ-SA)(6 months)
- Number of participants whose infant had routine follow-up pediatric appointments(6 months)
- Number of participants whose infant had acute care visits(6 months)
- Number of participants whose infant had emergency department visits(6 months)
- Number of participants whose infant was re-hospitalized(6 months)
- 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(6 months)
- Drug use(6 months)
研究者
Angela L Stotts
Professor
The University of Texas Health Science Center, Houston