Project BETTER: Bringing Education Through Technology, Empathic Listening, and Research - A Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Feasibility of the Intervention
研究概览
简要总结
The purpose of this study is to test a new educational technology-based program and brochure as a supplement to prenatal education from providers. The program provides education about common challenges that pregnant and parenting women receiving medication for Opioid Use Disorder (OUD) often face. Specifically, it addresses the transition from pregnancy to postpartum, possible neonatal abstinence syndrome (NAS) or neonatal withdrawal syndrome (NOWS), and interactions with child welfare.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •≥18 years of age
- •Meet criteria for Opioid Use Disorder
- •Currently receiving MOUD pharmacotherapy (including buprenorphine, buprenorphine/naloxone, or methadone)
- •Pregnant (<34 weeks EGA)
- •Initial in-person visit at OB MOTIVATE clinic for the current pregnancy ≤10 weeks ago
排除标准
- •Considering/planning adoption
- •Present with a serious cognitive/psychiatric impairment
- •Existing language barriers making true informed consent impossible
结局指标
主要结局
Feasibility of the Intervention
时间窗: Within 2 weeks of completing the intervention
Participants will complete a survey about the feasibility of the intervention consisting of 4 items rated on a 0 to 6 scale. Scores will be summed to yield a final feasibility score ranging from 0 to 24. Higher scores indicate higher feasibility.
Acceptability of the Intervention
时间窗: Within 2 weeks of completing the intervention
Participants will complete a survey about the acceptability of the intervention consisting of 10 items rated on a 1 to 5 scale. Higher scores indicated higher acceptability.
次要结局
- Change in Perceived Competence(Baseline to within 2 weeks of completing the intervention, up to 5 weeks)
- Change in Parental Competence(Baseline to within 2 weeks of completing the intervention, up to 5 weeks)