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Comparing the effectiveness of social stories and cognitive rehabilitation on social skills, executive functions, verbal and non-verbal communication skills and stereotypical behaviors of children with high-functioning autism

Protocol summary

Study aim
Determining the effectiveness of social stories and cognitive rehabilitation on social skills, executive functions, verbal and non-verbal communication skills, and stereotypical behaviors in children with high-functioning autism.
Design
A clinical trial with a control group and two intervention groups, single-blind, randomized, phase 3 will be conducted with 15 participants in each group, using SPSS software for analysis.
Settings and conduct
After selecting the samples and placing them in two intervention groups and a control group, the intervention will be implemented in the researcher's office in Isfahan, in the form of 14 individual sessions for each member of the intervention group, and a one-way blinding method will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 6 to 11 years; Higher than average intelligence quotient; Diagnosis of high-functioning autism based on assessment by a therapist from counseling centers; Absence of sensory impairments. Exclusion criteria: Receiving simultaneous rehabilitation; Undergoing medical or psychiatric treatments that interfere with the intervention process.
Intervention groups
Intervention One: 12 recorded social stories will be listened to and acted out, and questions will be asked to understand the situation. Intervention Two: An emotion-based rehabilitation package for emotional abilities and mental states will be administered. Intervention Three: Control group samples, who will not receive any intervention.
Main outcome variables
Improving the quality of life for children with autism and their families; Developing effective educational programs for children with autism in schools and rehabilitation centers; Preventing long-term social and behavioral problems in children with autism; Facilitating the social participation of children with autism in public and educational environments.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250308064990N1
Registration date: 2025-05-06, 1404/02/16
Registration timing: prospective

Last update: 2025-05-06, 1404/02/16
Update count: 0
Registration date
2025-05-06, 1404/02/16
Registrant information
Name
Sara Masoumi Torkamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 3176
Email address
sara.masoumitorkamani@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-21, 1404/02/31
Expected recruitment end date
2025-09-22, 1404/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of social stories and cognitive rehabilitation on social skills, executive functions, verbal and non-verbal communication skills and stereotypical behaviors of children with high-functioning autism
Public title
Comparing the effectiveness of social stories and cognitive rehabilitation in children with high-functioning autism
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 6 to 11 years. Having an intelligence quotient higher than average. High-functioning autism diagnosis based on the assessment of therapists at counseling centers. Lack of sensory deficits such as deafness and blindness. Informed consent and willingness to cooperate of children and their families.
Exclusion criteria:
Receiving simultaneous rehabilitation Absence for more than two sessions. Undergoing medical and psychiatric treatments that intervene in the educational process.
Age
From 6 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population is children with high-functioning autism in Isfahan, who will be selected through purposive sampling (based on research criteria) and then placed in the first and second experimental groups and the control group by simple random assignment, so that everyone has an equal chance of being selected.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since the placement of participants in each of the three groups is random, only the rehabilitation method used in that group will be described.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University - Ahvaz Branch
Street address
Faculty of Nursing and Midwifery, Islamic Azad University, Ahvaz Branch, Farhang Shahr
City
Ahvaz
Province
Khouzestan
Postal code
61349-37333
Approval date
2024-12-27, 1403/10/07
Ethics committee reference number
IR.IAU.AHVAZ.REC.1403.373

Health conditions studied

1

Description of health condition studied
Impairment in social skills, executive functioning, communication skills, and stereotypical behaviors in children with high-functioning Autism Spectrum Disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Social Skills
Timepoint
Measuring social skills before the start of the intervention and measurement after the completion of 14 intervention sessions on the effectiveness of social stories and cognitive rehabilitation on two intervention groups.
Method of measurement
Bellini and Hopf's Social Skills Profile of Autism

2

Description
Executive Functioning
Timepoint
Measuring executive functioning before the start of the intervention and measurement after the completion of 14 intervention sessions on the effectiveness of social stories and cognitive rehabilitation on two intervention groups.
Method of measurement
Brief Executive Functions Questionnaire

3

Description
Verbal and Nonverbal Communication Skills
Timepoint
Measuring verbal and nonverbal communication skills before the start of the intervention and measurement after the completion of 14 intervention sessions on the effectiveness of social stories and cognitive rehabilitation on two intervention groups.
Method of measurement
Bishop's Children's Communication Checklist

4

Description
Stereotypical Behaviors
Timepoint
Measuring Stereotypical Behaviors before the start of the intervention and measurement after the completion of 14 intervention sessions on the effectiveness of social stories and cognitive rehabilitation on two intervention groups.
Method of measurement
Gilliam Autism Rating

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Effectiveness of social stories: 12 social stories (one social story per session) will be recorded and played by the researcher, re-read, related pictures will be shown, and then acted out and questions will be asked to understand the situation. The stories will be explained to parents so that the necessary points can be observed in similar situations. This intervention will be carried out in 14 sessions, 60 minutes each, 2 sessions per week.
Category
Rehabilitation

2

Description
Intervention group 2: Effectiveness of cognitive rehabilitation: Emotion-based cognitive rehabilitation package, which teaches basic emotions to the individual at 10 different levels and provides feedback based on the individual's response. At the end of the session, the situations will be explained to the subject's parents. In each session, the subject will be asked questions about the content taught. This intervention will be carried out on the intervention group over 14 sessions of 60 minutes (three sessions per week).
Category
Rehabilitation

3

Description
Control group: Control group samples will not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Sara Masoumi Torkamani Psychology Center
Full name of responsible person
Sara Masoumi Torkamani
Street address
Second floor, No. 622, Shahid Yazdani Alley, Kh. Vahid.
City
Isfahan
Province
Isfehan
Postal code
8175945173
Phone
+98 31 3625 3666
Email
masoumis.1400@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University - Ahvaz Branch
Full name of responsible person
Marzieh Talebzadeh Shoushtari
Street address
Islamic Azad University, Ahvaz Branch, Farhang Shahr
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹-۳۷۳۳۳
Phone
+98 916 619 4772
Email
talebzadehmarzieh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University - Ahvaz Branch
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
Islamic Azad University - Ahvaz Branch
Full name of responsible person
Sara Masoumi Torkamani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Second floor, No. 622, Shahid Yazdani Alley, Kh. Vahid.
City
Isfahan
Province
Isfehan
Postal code
8175945173
Phone
+98 31 3625 3666
Email
masoumis.1400@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University - Ahvaz Branch
Full name of responsible person
Sara Masoumi Torkamani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Second floor, No. 622, Shahid Yazdani Alley, Kh. Vahid.
City
Isfahan
Province
Isfehan
Postal code
8175945173
Phone
+98 31 3625 3666
Email
masoumis.1400@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University - Ahvaz Branch
Full name of responsible person
Sara Masoumi Torkamani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Second floor, No. 622, Shahid Yazdani Alley, Kh. Vahid.
City
Isfahan
Province
Isfehan
Postal code
8175945173
Phone
+98 31 3625 3666
Email
masoumis.1400@gmail.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can potentially be shared after individuals have been anonymized.
When the data will become available and for how long
The access period begins 6 months after the publication of the results.
To whom data/document is available
All researchers working in academic and scientific institutions, specialists in psychology with related fields to the research topic, students, and researchers in this area.
Under which criteria data/document could be used
Results and data of the research aimed at improving the living and social conditions of children with high-functioning autism
From where data/document is obtainable
Specialized websites, reputable journals related to the research, and the email address of the researcher.
What processes are involved for a request to access data/document
After completing the research, presenting the final results, and defending it, the information will be published. Considering the time required for the publication of information, it will be accessible from reputable related information sources.
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