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

NCT07737405 | Not Yet Recruiting

• 1 other identifier: 07012025
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Intellectual Developmental Disorder

Outcome Measures

Primary Outcomes (1)

• anadian Occupational Performance Measure (COPM).

  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).

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

Study Arms (1)

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

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

Interventions

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

intervantion arm

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Miri Tal-Saban: lead

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 11, 2026

Record last verified: 2026-08