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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02797639
Other study ID # Onoac
Secondary ID
Status Completed
Phase N/A
First received May 28, 2016
Last updated June 10, 2016
Start date September 2014
Est. completion date May 2016

Study information

Verified date June 2016
Source Ono Academic College
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical 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).

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 2016
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 21 Years
Eligibility Inclusion Criteria:

1. A diagnosis of moderate IDD

2. Mobility independence

3. No secondary diagnosis of autism, nor sensory disabilities such as blindness or deafness

4. Students had been studying at the school for at least one year prior to data collection.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Co-PID
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.
IS
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ono Academic College

Outcome

Type Measure Description Time frame Safety issue
Primary 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. within one month after intervention completion No
Secondary 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. within one month after intervention completion No
Secondary 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 within one month after intervention completion No