Examining the Effectiveness of an Intervention Protocol Based on Cognitive-Occupational Principles (OP-CO; Cognitive Orientation to Daily Occupational Performance) for Children and Adolescents With Developmental Intellectual Disability: A Pilot Study

Обзор

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

Вмешательства

• Другое The CO-OP approach (Cognitive Orientation to daily Occupational Performance)
  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

Первичные конечные точки

• anadian Occupational Performance Measure (COPM). [Срок оценки: Time Frame: Before and after the intervention (approximately 12-15 weeks).]

Критерии участия

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

Exclusion Criteria: The exclusion criteria will be complex neurological or psychiatric diagnoses (e.g., cerebral palsy) and sensory limitations (e.g., blindness or deafness).

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07737405 · 07012025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗