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NCT Number: NCT07737405

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

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Treatment and study plan

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

Other

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

Primary outcomes

  1. anadian Occupational Performance Measure (COPM).

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Miri Tal-Saban

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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