History
# Registration date Revision Id
2 2023-01-29, 1401/11/09 254716
1 2019-10-31, 1398/08/09 109458
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Determine the effect of narrative discourse intervention based on the Supporting Knowledge in Language and Literacy (SKILL) program on discourse production and reading comprehension abilities in children with autism spectrum disorders in elementary schools
Design
This study is a two-blind clinical trial with parallel group. 30 children with autism are assigned in one of the two treatment groups using random blocks.
Settings and conduct
In this study, 30 children with autism were randomly divided into two groups. The first group receives the SKILL program and the second group receives the conventional speech therapy.Intervention is performed in centers and clinics affiliated to Tehran University of Medical Sciences. Intervention is provided individually, 3 sessions per week for two months. the ability of children to produce narrative speech and reading comprehension before and after treatment is evaluated, and the effectiveness of the SKILL program compared to conventional speech therapy is examined. In this study, trained assessors are not aware of the children's grouping, their demographic characteristics, the time of research, and the type of intervention received by each child. The participants and their families are unaware of intervention of the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteris: Having ages 8 to 12 years; Having Diagnosis of Autism Spectrum Disorders Persian speaking; Having a nonverbal intelligence score 70 and above; Having verbal fluent; Having the ability to decode words appropriate to age but weakness in reading comprehension; Exclusion criteria: If they have already received SKILL intervention program
Intervention groups
Group 1 receives SKILL program and group 2 receives the program of conventional speech therapy.
Main outcome variables
Macrostructure score; microstructure score; Index of narrative complexity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190505043477N1
Registration date: 2019-10-31, 1398/08/09
Registration timing: registered_while_recruiting

Last update: 2019-10-31, 1398/08/09
Update count: 1
Registration date
2019-10-31, 1398/08/09
Registrant information
Name
Elham Masumi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 5123
Email address
e-masumi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-14, 1398/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of narrative discourse intervention based on the Supporting Knowledge in Language and Literacy (SKILL) program on discourse production and reading comprehension abilities in children with autism spectrum disorders in elementary schools
Public title
"Narrative discourse intervention in children with autism"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be in the age range of 8 to 12 years Be in the second to fifth grade of elementary schools Have autism spectrum disorders; they have received a diagnosis of autism by a psychiatrist based on the DSM-V criteria and the diagnosis of autism should be supported by a speech and language pathologist using the GARS-2 questionnaire Be monolingual and Persian language Have be standard scores 70 and above on nonverbal portion of Wechsler Intelligence Test Have be verbal fluent Have be the ability to produce at least 100 spoken that is evaluated using the Farsi Narrative Norms Instrument guide Stories by speech and language pathologist Have be the ability to sit behind the table and keep the attention Have be the ability to decode words appropriate to age but weakness in reading comprehension; This is diagnosed by speech and language pathologists using reading and dyslexic tests (NEMA)
Exclusion criteria:
If they have already received SKILL intervention program Have be sensory damage (not compensated) for visual and auditory sensations Have be neurological problems (epilepsy, cerebral palsy) and other psychiatric disorders except autism
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
30 children with autism are assigned in one of the two treatment groups using random blocks. To randomize the size of blocks will be 4. According to the sample size of 30, which has been determined, 8 blocks will be produced using the online site (www.sealedenvelope.com). Group 1 received the Supporting Knowledge in Language and Literacy (SKILL) program and group 2 received the program of conventional speech therapy.
Blinding (investigator's opinion)
Double blinded
Blinding description
Evaluators first learn about evaluations and how they are done, Then, they are asked to do a pre-treatment evaluation. It should be noted that these evaluators are unaware of the grouping of children, their demographic characteristics, the timing of the research, and the type of intervention received by each child. Subsequently, these individuals will be asked to perform a post-treatment evaluation. The participants and their families are unaware of the compositions of the groups and do not visit each other during the trial sessions and outside the treatment environment..
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethcs committee of Tehran University of Medical Sciences.
Street address
Dr. Zahra Soleymani, Department of Speech Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Enghelab Ave., Pitch-e-shemiran, Tehran.
City
Tehran
Province
Tehran
Postal code
1148965141
Approval date
2019-07-25, 1398/05/03
Ethics committee reference number
IR.TUMS.FNM.REC.1398.087

Health conditions studied

1

Description of health condition studied
َAutism spectrum disorders
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder

Primary outcomes

1

Description
The macrostructures of narrative discourse score
Timepoint
Before intervention and after intervention
Method of measurement
The Farsi Narrative Norms Instrument will be used to evaluate Narrative discourse production ability. The Monitoring Indicators of Scholarly Language will be used to obtain the macrostructures scores.

2

Description
The microstructures of narrative discourse score
Timepoint
Before intervention and after intervention
Method of measurement
The Farsi Narrative Norms Instrument will be used to evaluate Narrative discourse production ability. The Monitoring Indicators of Scholarly Language will be used to obtain the microstructures scores.

3

Description
Index of narrative complexity
Timepoint
Before intervention and after intervention
Method of measurement
The Farsi Narrative Norms Instrument will be used to evaluate Narrative discourse production ability. The Monitoring Indicators of Scholarly Language will be used to obtain the index of narrative speech complexity.

Secondary outcomes

1

Description
Reading comprehension score
Timepoint
Before intervention and after intervention
Method of measurement
The reading and dyslexic tests will be used to evaluate children’s reading ability and reading comprehension.

Intervention groups

1

Description
Intervention group: The group receiving the Supporting Knowledge in Language and Literacy (SKILL) program, the intervention is provided individually, 3 sessions per week, and 50 minutes each session by a speech and language pathologist. The intervention period is two months and the program is provided in 24 sessions. The intervention program contains of three phases, phase 1: Teaching Story Structure and Causal Language, phase 2: Teaching Strategies for Creating a Situation Model, and phase 3: Teaching Strategies for Integration into Long Term Memory. The first phase of intervention consists of 17 lessons, the second phase is 11 lessons, and the third phase is 8 lessons.
Category
Rehabilitation

2

Description
Control group: The group receiving conventional speech therapy, the intervention is provided individually, 3 sessions per week, and 50 minutes each session by a speech and language pathologist. The intervention period is two months and the program is provided in 24 sessions. This group of children with autism does not teach narratives intervention according to the SKILL program. They receive conventional speech therapy by 3 speech and language pathologists in centers and autism schools.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Speech Therapy Clinic, Tehran University of Medical Sciences
Full name of responsible person
Zahra Soleymani
Street address
Dr. Zahra Soleymani, Department of Speech Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Enghelab Ave., Pitch-e-shemiran, Tehran
City
Tehran
Province
Tehran
Postal code
1148965141
Phone
+98 21 7753 5132
Fax
+98 21 7753 4133
Email
Soleymaniz@sina.tums.ac.ir
Web page address

2

Recruitment center
Name of recruitment center
Autism Charity Foundation
Full name of responsible person
Nasser Zojaji
Street address
No. 25, 4st Floor, Building 76, Kalantari Ave,Garani St., Tehran
City
Tehran
Province
Tehran
Postal code
1598833954
Phone
+98 21 8893 5955
Email
Info@autismcharity.ir
Web page address

3

Recruitment center
Name of recruitment center
Second April Center
Full name of responsible person
Saeed Rezayi
Street address
No. 7, Hafez Shirazi St., Bani Hashim Sq., Bani Hashim St., Resalat HwY, Tehran
City
Tehran
Province
Tehran
Postal code
1148965141
Phone
+98 21 2263 9683
Email
rezayi.saeed10@gmail.comt
Web page address

4

Recruitment center
Name of recruitment center
Iranian Autism Charity Association
Full name of responsible person
Saeedeh Saleh Gafari
Street address
No.8, East Laleh St., Hemat Bridge, South Sattari HWY, Tehran.
City
Tehran
Province
Tehran
Postal code
1473999763
Phone
+98 21 4461 4820
Fax
+98 21 4461 4317
Email
info@irautism.org
Web page address
http://www.irautism.org/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Rezaei
Street address
Qods Ave.,Keshavarz Blvd., Tehran University of Medical Science
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Soleymani
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Pitch-e-shemiran, Enghelab Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1148965141
Phone
+98 21 7753 5132
Fax
+98 21 7753 4133
Email
Soleymaniz@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Soleymani
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Pitch-e-shemiran, Enghelab Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1148965141
Phone
+98 21 7753 5132
Fax
+98 21 7753 4133
Email
Soleymaniz@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Masumi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, School of Rehabilitation, Tehran University of Medical Sciences, Pitch-e-shemiran, Enghelab Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1148965141
Phone
+98 21 7753 5123
Fax
+98 21 7753 4133
Email
e-masumi@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The results for the primary and secondary outcomes are published.
When the data will become available and for how long
The access period begins 12 months after publishing results.
To whom data/document is available
It will be available to speech therapy researchers working in academic and scientific institutions.
Under which criteria data/document could be used
It can be used for research and treatment in children with autism.
From where data/document is obtainable
By email to Dr. Zahra Soleymani and Elham Masoumi Soleymaniz@sina.tums.ac.ir, e-masumi@razi.tums.ac.ir
What processes are involved for a request to access data/document
It will be sent within two weeks of receiving the email.
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