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Determining & comparing the immediate and long term effects of speech therapy services through the consultative-collaborative, classroom-based, & pull-out models on the language outcomes of students in regular and exceptional schools

Protocol summary

Study aim
Determining & comparing the immediate effects and long term effects of the consultative-collaborative model, class-based model, & pull-out models on the language outcomes of students in regular and exceptional schools
Design
A clinical-controlled, parallel-group, double-blind, phase 3 trial of 400 students, with simple randomization by letter shuffling.
Settings and conduct
Normal and exceptional schools of Semnan city, where speech therapy services are assigned in the intervention group through three different models. Evaluators and recipients of services are completely unaware of the type of model and the allocation of groups.
Participants/Inclusion and exclusion criteria
Students with intellectual disability: intellectual disability without known cause, registered in Semnan exceptional schools, Have an effective presence during the academic year, receive speech therapy during education. children without intellectual disability: have not received any recommendation for any type of supportive service in the pre-school screening, registered in regular schools in areas with high socio-economic level and use the services of the same school throughout the academic year. Exclusion: if the student is removed from the list of school services or its rehabilitation team for any reason; suffering from diseases that endanger his education and rehabilitation process; Schools with speech therapist is present part-time or not at all; Non-cooperation of child, teacher and family
Intervention groups
Pull-out, consultative-collaborative and class-based speech therapy services will be provided to the group receiving services based on their needs. The control group will not receive any speech therapy services.
Main outcome variables
language outcomes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180612040069N2
Registration date: 2022-10-19, 1401/07/27
Registration timing: prospective

Last update: 2022-10-19, 1401/07/27
Update count: 0
Registration date
2022-10-19, 1401/07/27
Registrant information
Name
Masoomeh Salmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3346 8920
Email address
salmani_masoome@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining & comparing the immediate and long term effects of speech therapy services through the consultative-collaborative, classroom-based, & pull-out models on the language outcomes of students in regular and exceptional schools
Public title
speech therapy service delivery models
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
In children with intellectual disability (ID): non-specified intellectual disability should have been confirmed by a psychologist using Leiter test, , and , . For typical children: They , they , and children with ID registered in special needs schools of Semnan city for 2022-2023 children with ID should have effective presence during educational year children with ID should be in the confirmed list to receive speech therapy services typical children should not have received any recommendation for any type of services (medical, educational and/or rehabilitative) in the screening for school inertance. typical children should have been registered in highly socio-economic private or mainstream schools typical children should remain on that schools for the whole of the educational year (2022-2023)
Exclusion criteria:
for the children with Intellectual disability, if the child -for any reason- has been eliminated from the schooling service or rehabilitation program. In both groups, if the child suffers from diseases that jeopardize her education and / or rehabilitation proces. Schools where the speech therapy staff is present part-time or not at all will be excluded from the study. In both groups, the lack of cooperation of the child, teacher and family A child without intellectual disability, if the student leaves the school for any reason and uses the educational services of other schools.
Age
From 6 years old to 7 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 400
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, schools will be divided into intervention and control based on a simple random method (envelops shuffling). In the school receiving the intervention, the classes will be assigned in the same way to receive speech therapy services based on three different models - pull-out, classroom-based and collaborative-consultative.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, students with intellectual disability are unaware of which model they receive speech therapy services. Students without intellectual disabilities are unaware not only of the delivery model, but even that they are receiving speech therapy services. Before, immediately after the intervention and at the end of the academic year, 5 speech therapists will assess the children. These evaluators will not be aware of the allocation of services, type of model, etc.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
5km. of Damghan road, Pardis campus of Semnan University of Medical Sciences, Faculty of Rehabilitation, Department of Speech therapy
City
Semnan
Province
Semnan
Postal code
3513138111
Approval date
2022-10-10, 1401/07/18
Ethics committee reference number
IR.SEMUMS.REC.1401.163

Health conditions studied

1

Description of health condition studied
typical children with the risk of language problems & children with intellectual disability
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Language outcomes
Timepoint
Measure language outcomes at week 1, 12, and 28
Method of measurement
test of language development-p 3

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: receiving speech therapy services based on the pull-out model; The second intervention group: receiving speech therapy services based on the consultation-collaboration model; The third intervention group: receiving speech therapy services based on the class-based model
Category
Rehabilitation

2

Description
Control group: This group will not have any speech therapy services.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
regular and exceptional schools
Full name of responsible person
Masoomeh Salmani
Street address
5 km. of Damghan road, Pardis campus of Semnan university of medical sciences, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
salmani_masoome@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Majid Mir Mohammadkhani
Street address
Deputy of research and technology, Semnan University of Medical Sciences, Amirkabir square, SemnanSemnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3345 1336
Email
majidmirmohammadkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Masoomeh Salmani
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
5 km. of Damghan Road, Semnan University of Medical Sciences, Rehabilitation Faculty, Speech and Language Therapy Department
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3346 8920
Fax
Email
salmani_masoome@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Masoomeh Salmani
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
5 km. of Damghan Road, Semnan University of Medical Sciences, Rehabilitation Faculty, Speech and Language Therapy Department
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3346 8920
Fax
Email
salmani_masoome@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Masoomeh Salmani
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
5 km. of Damghan Road, Semnan University of Medical Sciences, Rehabilitation Faculty, Speech and Language Therapy Department
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3346 8920
Fax
Email
salmani_masoome@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions and department of education
Under which criteria data/document could be used
As a pilot for further studies or for educational policies or as basic data
From where data/document is obtainable
by sending email to the salmani_masoome@yahoo.com
What processes are involved for a request to access data/document
Proposal or ID card photo
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