Mental Retardation and Developmental Disabilities With Organic ConditionNCT02797639
Collaborative Consultation for Participation Among Students With IDD
A study testing Co-PID and IS in people with Mental Retardation and Developmental Disabilities With Organic Condition, run by Ono Academic College.
Trial summary
Objective: Developing and corroborating the Collaborative Consultation for Participation of Students with Intellectual Disability (Co-PID) program, for enhancing classroom participation among students with moderate Intellectual and Developmental Disability (IDD). Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Mental Retardation and Developmental Disabilities With Organic Condition
- What is being tested?
- Co-PID and IS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A diagnosis of moderate IDD
- Mobility independence
- No secondary diagnosis of autism, nor sensory disabilities such as blindness or deafness
- Students had been studying at the school for at least one year prior to data collection.
Who cannot join
- -
About this study
Official title: The Effectiveness of Collaborative Consultation for Participation Among Students With Moderate Intellectual Disability (Co-PID)
Objective: Developing and corroborating the Collaborative Consultation for Participation of Students with Intellectual Disability (Co-PID) program, for enhancing classroom participation among students with moderate Intellectual and Developmental Disability (IDD).
Method: study took place in two special education schools and included students with moderate IDD (n=60) and their teachers (n=11). The settings were randomly assigned to intervention or control group. In the intervention group, Co-PID program was employed; in the control group an In-Service (IS) was employed. Participation was evaluated at pre-test and post-test.
Read the detailed description
The study was conducted in three phases: (a) pre-test; (b) intervention; and (c) post-test
Pre-test. Using the 'Structured Observation of Students' Participation in Class', each student in both groups was observed four times during different lessons (with a 1-week interval between observations) to establish a baseline for level of participation. All pre-test observations were conducted between the 2nd and 3rd months of the school year, by an occupational therapist with 8 years of experience working with children with developmental delays. The observer was trained in using the 'Structured Observation of Students' Participation in Class' and was not blinded to the schools' assignment (Co-PID or IS). During this period the teachers, who were blinded to the school assignment, were asked to teach in a regular manner without changing the content or design of their lessons. Next, the teachers filled out the School Function Assessment questionnaire for each student. Finally, based on the 'Structured Observation of Students' Participation in Class' scores and teachers' familiarity with the students' function, the occupational therapist and each of the participating teachers jointly filled-out the 'Goal Attainment Scaling' form. Each student had three goals, one for each of the participation skills: Communicating, Choosing and Initiating. Post-test. This phase was conducted during the 9th and 10th months of the school year, and was identical to the pre-testing phase in terms of both process and measures used
- Being tested
- Co-PID, IS
- Keywords
- Intellectual Disability, Collaborative Consultation, Participation
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-PIDOther
The program was carried out by the school occupational therapist and homeroom teachers. The Co-PID had two phases. The first phase was a 1.5 hour in-service meeting that focused on the concept of "Participation".
In the second phase of the Co-PID intervention, a collaborative consultation model was used. It included eight 45-minute consultation meetings, which took place every other week over a 3-months period. The meetings took place between the occupational therapist and each teacher, with the purpose of brainstorming; thinking of activities that the teacher could implement during the lessons for enhancing participation among the students.
ISOther
IS group included three meetings, a 1.5 hour in-service meeting focusing on the concept of participation, and two more workshop meetings aimed at sharing teachers' experience.
| Study group | Role | What they receive |
|---|---|---|
| Co-PID | Experimental | Eight collaborative consultation meetings between occupational therapist to each teacher in purpose of enhancing participation of students in class Receives: Other: Co-PID |
| In-service | Active comparator | Three in- service meetings to all homeroom teachers together, in purpose of enhancing participation of students in class Receives: Other: IS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Observation of Students' Participation in Class
A structured observation for examining participation of students with moderate IDD in the classroom. It includes 25 items that focus on three classroom participation skills: (a) Communicating (listening and expressing; 7 statements); (b) Choosing (8 statements), and (c) Initiating (10 statements). The observer rates the active participation of students during an entire lesson (about 45 minutes), with regards to each of the items, on a scale of 0 (Does not participate) to 4 (Fully participates). In addition, each statement includes a 'Not relevant' option - when the student was not given the opportunity to perform the task.
Measured: within one month after intervention completion
Secondary outcomes (2)
School Function Assessment Questionnaire "through study completion"
a criterion-referenced, standardized assessment that measures students' performance in functional tasks that support their participation in the school program. The School Function Assessment includes three parts: (a) Participation, (b) Task supports and (c) Activity performance. It is completed by one or more school professionals who are highly familiar with the students being observed.
Measured: within one month after intervention completion
Goal Attainment Scaling "through study completion"
a method for scoring the extent to which the client's goals are achieved in the course of intervention. Functional goals are determined through a collaborative process between clinician and client or caregiver, prior to intervention. Scoring is based on a scale, where the user breaks-down each goal's performance on a 5-point scale ranging from -2 to 2
Measured: within one month after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startSep 2014
- Primary completionAug 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Retardation and Developmental Disabilities With Organic ConditionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Academic College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efrat Selanikyo, Ono Academic College
- Investigators
- Naomi Weintraub, Prof, Study director, Hebrew University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797639
- Sponsor's protocol ID
- Onoac
- Status last verified
- Jun 2016
- First submitted
- 28 May 2016
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Collaborative Consultation for Participation Among Students With Moderate Intellectual Disability (Co-PID)
- ClinicalTrials.gov ID
- NCT02797639
- Acronym / sponsor ID
- Onoac
- Keywords
- Intellectual Disability, Collaborative Consultation, Participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ono Academic CollegeUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 Jun 2016 (estimated)
- 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.
Objective: Developing and corroborating the Collaborative Consultation for Participation of Students with Intellectual Disability (Co-PID) program, for enhancing classroom participation among students with moderate Intellectual and Developmental Disability (IDD).
Method: study took place in two special education schools and included students with moderate IDD (n=60) and their teachers (n=11). The settings were randomly assigned to intervention or control group. In the intervention group, Co-PID program was employed; in the control group an In-Service (IS) was employed. Participation was evaluated at pre-test and post-test.
Detailed description
The study was conducted in three phases: (a) pre-test; (b) intervention; and (c) post-test
Pre-test. Using the 'Structured Observation of Students' Participation in Class', each student in both groups was observed four times during different lessons (with a 1-week interval between observations) to establish a baseline for level of participation. All pre-test observations were conducted between the 2nd and 3rd months of the school year, by an occupational therapist with 8 years of experience working with children with developmental delays. The observer was trained in using the 'Structured Observation of Students' Participation in Class' and was not blinded to the schools' assignment (Co-PID or IS). During this period the teachers, who were blinded to the school assignment, were asked to teach in a regular manner without changing the content or design of their lessons. Next, the teachers filled out the School Function Assessment questionnaire for each student. Finally, based on the 'Structured Observation of Students' Participation in Class' scores and teachers' familiarity with the students' function, the occupational therapist and each of the participating teachers jointly filled-out the 'Goal Attainment Scaling' form. Each student had three goals, one for each of the participation skills: Communicating, Choosing and Initiating. Post-test. This phase was conducted during the 9th and 10th months of the school year, and was identical to the pre-testing phase in terms of both process and measures used
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Co-PID | Experimental | Other: Co-PIDEight collaborative consultation meetings between occupational therapist to each teacher in purpose of enhancing participation of students in class |
| In-service | Active comparator | Other: ISThree in- service meetings to all homeroom teachers together, in purpose of enhancing participation of students in class |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- A diagnosis of moderate IDD
- Mobility independence
- No secondary diagnosis of autism, nor sensory disabilities such as blindness or deafness
- Students had been studying at the school for at least one year prior to data collection.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Co-PIDThe program was carried out by the school occupational therapist and homeroom teachers. The Co-PID had two phases. The first phase was a 1.5 hour in-service meeting that focused on the concept of "Participation". In the second phase of the Co-PID intervention, a collaborative consultation model was used. It included eight 45-minute consultation meetings, which took place every other week over a 3-months period. The meetings took place between the occupational therapist and each teacher, with the purpose of brainstorming; thinking of activities that the teacher could implement during the lessons for enhancing participation among the students. | Other | Co-PID |
| ISIS group included three meetings, a 1.5 hour in-service meeting focusing on the concept of participation, and two more workshop meetings aimed at sharing teachers' experience. | Other | In-service |
Primary outcome
Structured Observation of Students' Participation in Class
Time frame: within one month after intervention completion
A structured observation for examining participation of students with moderate IDD in the classroom. It includes 25 items that focus on three classroom participation skills: (a) Communicating (listening and expressing; 7 statements); (b) Choosing (8 statements), and (c) Initiating (10 statements). The observer rates the active participation of students during an entire lesson (about 45 minutes), with regards to each of the items, on a scale of 0 (Does not participate) to 4 (Fully participates). In addition, each statement includes a 'Not relevant' option - when the student was not given the opportunity to perform the task.
2 secondary outcomes
School Function Assessment Questionnaire "through study completion"
Time frame: within one month after intervention completion
Goal Attainment Scaling "through study completion"
Time frame: within one month after intervention completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Naomi Weintraub, Prof study director
Hebrew University
Questions about this trial
What is this clinical trial studying?
A study testing Co-PID and IS in people with Mental Retardation and Developmental Disabilities With Organic Condition, run by Ono Academic College.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jun 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Structured Observation of Students' Participation in Class (time frame: within one month after intervention completion). 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 14 Jun 2016.