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Not yet recruitingNCT07737405Updated Aug 11, 2026

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

An interventional study of The CO-OP approach (Cognitive Orientation to daily Occupational Performance) in Intellectual Developmental Disorder, sponsored by Miri Tal-Saban. Not yet recruiting. Open to participants aged 10 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Miri Tal-Saban · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
10 Years to 21 Years
Sex
All
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Study 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

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Conditions studied

  • Intellectual Developmental Disorder
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In context

Intellectual Disability

387 studies on the registry are indexed under Intellectual Disability; 105 are open to participants now.

This study's planned enrollment of 10 is below the median of 58 across 248 interventional studies indexed under Intellectual Disability.

Browse Intellectual Disability studies →

Lead sponsor

Miri Tal-Saban is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    intervantion arm

    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

  • OtherThe 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

06

What researchers measure

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

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07737405
Lead sponsor
Miri Tal-Saban
Responsible party
Miri Tal-Saban (Principal Investigator, Hebrew University of Jerusalem) — Sponsor-investigator
First posted
Jul 30, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Aug 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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