Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Feasibility of the CareMeds 3 sessions
研究概览
简要总结
The current study will assess the acceptability and feasibility of the CareMeds intervention with a larger sample (N = 100) across multiple sites in Buffalo, NY, and Atlanta, GA.
详细描述
This is a pilot randomized controlled trial of the CareMeds program to assess feasibility and obtain preliminary efficacy data among families of young children (ages 3-9) with ALL. The objective of this aim is to implement our study procedures and study conditions (CareMeds vs. usual care control). We hypothesize that pilot findings will support the feasibility of the intervention and suggest important improvements in our behavioral secondary outcomes (i.e., behavioral parenting skills, medication adherence
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
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parent of a child who is diagnosed and being treated for any type of acute lymphoblastic leukemia (ALL) at a study site.
- •Parent has primary medication responsibility.
- •Pediatric patient aged 3-9 years
- •Child on therapy that includes home-based oral anti-cancer medication, such as 6-MP.
- •Parent has verbal English or Spanish fluency.
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Parent is unwilling or unable to follow protocol requirements
研究组 & 干预措施
CareMeds Intervention
Participants complete the CareMeds parent training sessions during weeks 2, 3 and 4.
干预措施: CareMeds Intervention (Behavioral)
Usual Care
Usual care consists of medical consultations and supportive care, The usual care group will serve as a delayed intervention/wait list group for which 3 parent training sessions will be offered during weeks 13 through 15.
干预措施: Usual Care Group (Behavioral)
结局指标
主要结局
Feasibility of the CareMeds 3 sessions
时间窗: up to 3 years
enrollment rates will be measured by number of consents . Reasons for refusal will also be captured
次要结局
- Behavioral Parenting skills(Weeks 1, 4 and 12.)
- Oral Chemotherapy adherence(UP to week 12)