Phase 2 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 8
- 主要终点
- Severity of autism
研究概览
简要总结
Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute at Western Oregon University (WOU) will be conducting research on the effect of a parent-delivered massage program on measures of autism and general development in young children with autism. Families will participate in an initial training, and receive 24 sessions of ongoing support and training from a trained therapist over the first nine months.
详细描述
Children will be randomly divided into treatment groups and wait-list control groups. The control groups begin treatment five months after the treatment groups begin.
All children will be tested on three occasions in the first year: prior to beginning treatment, and five and twelve months later. Follow-up testing will be conducted at the end of the second year. Results will be shared with parents at the end of each year. Testers will remain blinded as to which group is currently receiving treatment.
There is no cost to parents for participation in this research study. Families meeting the eligibility criteria will be accepted into the study on a first-come, first-served basis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a medical and/or educational diagnosis of autism
- •Be under age 6
- •Parents willing to attend the parent training session and transport the child to treatment sessions with trained staff 20 times in the first five months
- •Parents willing to give the fifteen-minute massage daily
- •Parents willing not to start any new interventions unless medically necessary
排除标准
- •Taking psychoactive medication or pharmaceutical chelation therapy
- •Additional chronic disability (for example, cerebral palsy or uncontrolled seizures)
- •Receiving more than five hours per week of intensive behavioral treatment for autism (e.g. ABA therapy)
结局指标
主要结局
Severity of autism
时间窗: 5 months
The Childhood Autism Rating Scales will be used to measure this.
次要结局
- Developmental skills(5 months)
研究者
Louisa Silva
Principal Investigator, Visiting Professor
Western Oregon University