Intellectual Developmental DisorderNCT07737405
Examining the Effectiveness of an Intervention Protocol Based on CO-OP for Children and Adolescents With IDD: A Pilot Study
A study testing The CO-OP approach (Cognitive Orientation to daily Occupational Performance) in people with Intellectual Developmental Disorder, run by Miri Tal-Saban.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Intellectual Developmental Disorder
- What is being tested?
- The CO-OP approach (Cognitive Orientation to daily Occupational Performance)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- complex neurological or psychiatric diagnoses (e.g., cerebral palsy)
- sensory limitations (e.g., blindness or deafness).
About this study
Official title: Examining the Effectiveness of an Intervention Protocol Based on CO-OP 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
- Conditions
- Intellectual Developmental Disorder
- Being tested
- The CO-OP approach (Cognitive Orientation to daily Occupational Performance)
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: The CO-OP approach (Cognitive Orientation to daily Occupational Performance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Time Frame: Before and after the intervention (approximately 12-15 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual Developmental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miri Tal-Saban
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Miri Tal-Saban, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737405
- Sponsor's protocol ID
- 07012025
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of an Intervention Protocol Based on CO-OP for Children and Adolescents With Developmental Intellectual Disability: A Pilot Study
- ClinicalTrials.gov ID
- NCT07737405
- Acronym / sponsor ID
- 07012025
- Conditions
- Intellectual Developmental Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Miri Tal-SabanUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervantion arm | Experimental | Other: 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 |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- complex neurological or psychiatric diagnoses (e.g., cerebral palsy)
- sensory limitations (e.g., blindness or deafness).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | intervantion arm |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The CO-OP approach (Cognitive Orientation to daily Occupational Performance) in people with Intellectual Developmental Disorder, run by Miri Tal-Saban.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anadian Occupational Performance Measure (COPM). (time frame: Time Frame: Before and after the intervention (approximately 12-15 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.