Rare Group Problem Management Plus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
Participants are being asked to be in the study if they are the parent or legal guardian of a child (>1 year or <18 years old) with a rare condition.
The group based psychoeducational intervention is called Rare Group Problem Management Plus.
Rare Group PM Plus may help adults with practical and emotional problems. It is a group program (there will be other men or women with similar problems) It happens once a week for 5 weeks (each session lasts 90 minutes)
Participants will complete assessments before they start Rare Group PM+. Participants will also complete the same assessments within a few weeks of completing Rare Group PM+. Assessments should only take one hour.
Study visits are by Telemedicine. Participants will need a smart phone or tablet. If they do not have a smart phone or tablet, the study team will help with this.
Participants will not receive any materials or money or medication.
详细描述
Participants are being asked to be in the study because they are the parent or legal guardian of a child (infancy up to 21 years old) with a rare condition.
The group based psychoeducational intervention is called Rare Group Problem Management (PM) Plus intervention.
Rare Group PM Plus may help adults with practical and emotional problems It is a group program (there will be other men or women with similar problems) It happens once a week for 5 weeks (each session lasts 90 minutes)
Investigators will be recruiting for 3 groups of 10 families each, for a total of 30 families who will participate in this study from Children's National Hospital.
There are 7 study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Family caregiver aged 18 years or older of a child with a rare disease from infancy to age 21 years.
- •Understands and speaks English or Spanish. Reading or health literacy is not required.
- •Signed consent.
- •Signed waiver of assent for child.
排除标准
- •Family caregiver is under the age of 18 years.
- •Child with the rare disease is over the age of 21 years.
- •Family caregiver is actively suicidal, homicidal, or psychotic.
- •Family caregiver is impaired (cognitively or by drugs or alcohol).
- •Family caregiver has a low level of distress.
结局指标
主要结局
Acceptability
时间窗: 2 weeks post-intervention (Session 5)
As measured by retention at 2 weeks post-intervention assessment
次要结局
未报告次要终点
研究者
Maureen Lyon
Clinical Health Psychologist
Children's National Research Institute