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临床试验/NCT01794013
NCT01794013已完成不适用

A Randomized Controlled Trial of DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities

Kingkaew Pajareya1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
The change in The Child Behavior Rating Scale (CBRS)

研究概览

简要总结

The objective of this study is to test whether adding the parent training program using the relationship-based approach could help the children with development disabilities (DDs) would confer additional benefits over routine clinical care available to both groups in terms of improving their development and reducing behavior problems.

详细描述

The objective of this study is to test whether adding the parent training program using the relationship-based approach could help the children with development disabilities (DDs) would confer additional benefits over routine clinical care available to both groups in terms of improving their development and reducing behavior problems.

The study treatment involves intervention entirely with parents of children with DDs, rather than directly with the children themselves. Before the first session, all parents in the intervention group had to learn about DIR/ Floortime™ model approach through 1 - hour one on one coaching (at the beginning oft the study, the end of 1st and 3rd month) and through 2 hours DVD lecture and a pocket book. The parent in the intervention group will be asked to carry out FloortimeTM together with using Floortime strategies during daily activities a minimum of 15 hour per week. Meanwhile, the children in the control groups will continue their routine care. The baseline assessment and follow up time schedule were similar to those of the intervention group.

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
24 Months 至 72 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •The children with developmental disabilities :
  • •age between 2 - 6 years of age
  • •living with the primary caregiver for at least 6 months.

排除标准

  • •The children are excluded if :
  • •serious medical problems (e.g. severe congenital heart disease, intractable seizure (a seizure frequency of at least one attack per month during six months despite receiving two anticonvulsant drugs)
  • •their parents : not literate, has known chronic psychiatric, or physical illness

研究组 & 干预措施

Parent trianing

Active Comparator

The parent training group will learn about DIR/ Floortime™ model approach through one on one coaching for 1 hour at the beginning of the study, the end of 1st and 3th month and through 2 hours DVD lecture and a pocket book.

干预措施: Parent training (Behavioral)

Routine care

Active Comparator

The children in the control group will continue their standard routine care.

干预措施: Routine care (Behavioral)

结局指标

主要结局

The change in The Child Behavior Rating Scale (CBRS)

时间窗: 4 months

次要结局

  • The change in The Functional Emotional Developmental Questionnaire (FEDQ)(4 months)

研究者

发起方
Kingkaew Pajareya
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kingkaew Pajareya

Faculty of Medicine Siriraj Hospital

Mahidol University

研究点 (1)

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