Coping and Caring for Families With Babies With Down Syndrome. A Family-centered Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Motor Development
研究概览
简要总结
The objective is to compare the impact of standard infant physical therapy and the family-centered program, Coping with and Caring for Infants with Special Needs (COPCA), on infants born with Down syndrome. This is a randomized controlled trial that will be carried out in the patients' homes and outpatient settings in Spain between January 2024 and March 2024. An evaluation battery will be used that includes child and family outcomes and video analysis of therapy sessions.
The Infant Motor profile will be the primary outcome instrument.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Babies with Down syndrome
- •Families involved in Pediatric Physical Therapy
排除标准
- •Other associated developmental disorders
- •To not speak Spanish
- •Do not sign informed consent
结局指标
主要结局
Motor Development
时间窗: 3-6-18 months.
INFANT MOTOR PROFILE Results achieved between the 10% and 90% percentiles indicate adequate motor development. Results between the 5% and 10% percentiles indicate a risk for delays or problems in gross motor development.
次要结局
- Family empowerment(3-6-18 months)
研究者
Elena Piñero Pinto
Professor
University of Seville