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临床试验/NCT07737405
NCT07737405尚未招募不适用

Examining the Effectiveness of an Intervention Protocol Based on CO-OP for Children and Adolescents With Developmental Intellectual Disability: A Pilot Study

Miri Tal-Saban0 个研究点目标入组 10 人开始时间: 2026年10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
尚未招募
发起方
入组人数
10
主要终点
anadian Occupational Performance Measure (COPM).

研究概览

简要总结

Background and Rationale: The current study is based on the knowledge about the widespread impact of intellectual developmental disabilities (IDD) on the functioning of children and adolescents and the lack of evidence-based intervention programs for this population. There is preliminary research evidence about the effectiveness of cognitive-functional intervention according to the OP-CO approach among children with various cognitive impairments. This study is part of a larger study that aims to adapt the intervention protocol adapted according to the principles of the OP-CO approach for children/adolescents with IDD and will focus on an initial examination of the effectiveness of the intervention according to the adapted protocol. The importance of the study for the topic of intellectual disability: Developing an adapted, applicable and evidence-based protocol can address the unique needs of the population of children/adolescents with IDD (up to age 21) and serve as a tool for occupational therapists who treat this population. The development of the protocol will respond to The lack of evidence-based intervention programs for this population.

Research methodology: A pilot study that will be based on the results of a previous study that includes the development of an adapted intervention protocol.

In this study, an intervention will be delivered for approximately 12-15 weeks once a week for 45 minutes by 3-5 occupational therapists among approximately 10 children/adolescents up to the age of 21 with MSH. The intervention will use standard tools and documentation of the intervention in a therapist diary

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
10 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Children and adolescents aged 10-21 years
  • •a primary diagnosis of mild to moderate IDD by The Ministry of Welfare and Social Affairs
  • •enrolled in special education settings and settings with a long school day/stay; - able to communicate verbally in Hebrew and define at least three goal activities with help from parents/educational/therapeutic staff.

排除标准

  • •complex neurological or psychiatric diagnoses (e.g., cerebral palsy)
  • •sensory limitations (e.g., blindness or deafness).

研究组 & 干预措施

intervantion arm

Experimental

Exploratory study 3-5 Occupational therapists will offer children and adolescents with IDD to participate in an intervention (once a week, 45 minutes for 12-15 weeks - duration of intervention may vary). Standardized tools will be delivered to children/adolescents before and after the intervention

干预措施: The CO-OP approach (Cognitive Orientation to daily Occupational Performance) (Other)

结局指标

主要结局

anadian Occupational Performance Measure (COPM).

时间窗: Time Frame: Before and after the intervention (approximately 12-15 weeks).

This measure evaluates changes in participants' perceptions of their daily task performance and satisfaction before and after the intervention. Scale Details: Scale Title: COPM Performance and Satisfaction Scales Range: 1 to 10 Interpretation: Higher scores indicate better performance and greater satisfaction. Time Frame: Before and after the intervention (approximately 12-15 weeks).

次要结局

未报告次要终点

研究者

发起方
Miri Tal-Saban
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Miri Tal-Saban

Principal Investigator

Hebrew University of Jerusalem

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