Protocol summary

Summary
The purpose of this study was to investigate the effectiveness of the storytelling training based on dialogue on language and social skills of primary school girls with mild intellectual disability. The research method was experimental and pretest-posttest design with control group was used. In this research, an exceptional primary school of district 2 from Isfahan city was selected using purposeful sampling. Then, 30 students were selected regarding inclusion criteria of the research and sample with the table of random numbers was randomly assigned to two groups: 1-experimental and 2-control groups. The inclusion criteria included 70-55 IQ, parental consent, the range of 7 to 9 years old and exclusion criterion was been affected by other physical and mental disorders. The storytelling training based on dialogue in 8 sessions was conducted with question- response techniques in experimental group, while the control group did not receive any intervention. The instruments were the test of language developmental (TOLD-P3) and Social Skills Rating Scale (SSRS). The primary outcomes of the study included language skills and social skills. This research did not have any negative secondary outcomes. in this case, as a result of qualitative observation, we found positive secondary outcomes such as improvement in the students relationship with each other and with trainer.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017091236158N1
Registration date: 2017-10-27, 1396/08/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-27, 1396/08/05
Registrant information
Name
Afrooz Makaremnasab
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3268 6702
Email address
f.sadatmadani@edu.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2016-12-20, 1395/09/30
Expected recruitment end date
2017-03-18, 1395/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the storytelling training based on Dialogue on language and social skills of primary school girls with mild intellectual disability
Public title
The effect of the storytelling training based on Dialogue on language and social skills
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: IQ of 70-55; parents' consent; The range of 7 to 9 years old. Exclusion criteria: other physical and mental disabilities.
Age
From 7 years old to 9 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezargerib Street, Azadi Square, Isfahan
City
Isfahan
Postal code
81746-73441
Approval date
2017-09-04, 1396/06/13
Ethics committee reference number
IR.UI.REC.1396.001

Health conditions studied

1

Description of health condition studied
Mild mental retardation
ICD-10 code
F70
ICD-10 code description
Mild mental retardation

2

Description of health condition studied
Socialized conduct disorder
ICD-10 code
F91
ICD-10 code description
Conduct disorders

3

Description of health condition studied
Language disorder
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Social skill
Timepoint
Before intervention and after intervention
Method of measurement
Social Skills Rating System (Gresham & Eliot) Questionnaire

2

Description
Language skill
Timepoint
Before intervention and after intervention
Method of measurement
The test of language developmental (TOLD-P3)

Secondary outcomes

1

Description
Improvement in the students relationship with each other and trainer
Timepoint
Before intervention and after intervention
Method of measurement
The qualitative observation

Intervention groups

1

Description
Intervention group: The intervention group received 8 sessions of Dialogue story telling training based on graver Whitehurst's techniques and each session was 45 minutes. Topics were included the treasury of the word, the language of expression, the language of reception, participation and cooperation, self-control and decisiveness.
Category
Behavior

2

Description
Control group: No intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Exceptional school
Full name of responsible person
Afrooz Makaremnasab
Street address
Farshchian Exceptional school, Shahid Tavana Street, Ahmadabad Street, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Amir Rahimi
Street address
Isfahan University of Medical Sciences, Hezargerib Street, Azadi Square, Isfahan
City
Isfahan
Grant name
_
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Afrooz Makaremnasab
Position
Masters
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezargerib Street, Azadi Square, Isfahan
City
Isfahan
Postal code
81746-73441
Phone
+98 31 3793 2640
Fax
-
Email
F.sadatmadani@edu.ui.ac.ir; Afroozmakarem@yahoo.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Yarmohammadian
Position
Ph.D.
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezargerib Street, Azadi Square, Isfahan
City
Isfahan
Postal code
81746-73441
Phone
+98 31 3771 0823
Fax
-
Email
a.yarmohammadian@edu.ui.ac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Afrooz Makaremnasab
Position
Masters
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezargerib Street, Azadi Square, Isfahan
City
Isfahan
Postal code
81746-73441
Phone
+98 31 3793 2640
Fax
-
Email
F.sadatmadani@edu.ui.ac.ir; Afroozmakarem@yahoo.com
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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