Not Yet RecruitingNot Applicable

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

10 participantsStarted 2026-10

Plain-language 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

Who can participate

Age range

10 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

anadian Occupational Performance Measure (COPM).

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

Trial details

NCT IDNCT07737405

SponsorMiri Tal-Saban

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

View on ClinicalTrials.gov More Intellectual Developmental Disorder trials