Developing Instructional Video for Parents and Investigating its Effectiveness on Communication and Play Skills of Nonverbal Children with Autism Spectrum Disorders
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Protocol summary
Clinical trial with control group, single blind, randomized, on 18 patients. For randomization, random selection of 18 envelopes containing one of the control and intervention words was used (9 envelopes containing the control word and 9 envelopes containing the intervention word).
Clinical trial with control group, single blind, randomized, on 32 patients. For randomization, random selection of 32 envelopes containing one of the control and intervention words was used (16 envelopes containing the control word and 16 envelopes containing the intervention word).
Clinical trial with control group, single blind, randomized, on 1832 patients. For randomization, random selection of 1832 envelopes containing one of the control and intervention words was used (916 envelopes containing the control word and 916 envelopes containing the intervention word).
کارآزمایی بالینی دارای گروه کنترل، یک سویه کور ، تصادفی شده، فاز 2 بر روی ۱۸ بیمار. برای تصادفی سازی از برداشتن تصادفی ۱۸ پاکت های حاوی یکی از واژه های کنترل و مداخله استفاده شد (۹ پاکت حاوی واژه کنترل و ۹ پاکت حاوی واژه مداخله ).
کارآزمایی بالینی دارای گروه کنترل، یک سویه کور ، تصادفی شده، فاز 2 بر روی 32 بیمار. برای تصادفی سازی از برداشتن تصادفی 32 پاکت های حاوی یکی از واژه های کنترل و مداخله استفاده شد (16 پاکت حاوی واژه کنترل و 16 پاکت حاوی واژه مداخله ).
کارآزمایی بالینی دارای گروه کنترل، یک سویه کور ، تصادفی شده، فاز 2 بر روی ۱۸32 بیمار. برای تصادفی سازی از برداشتن تصادفی ۱۸32 پاکت های حاوی یکی از واژه های کنترل و مداخله استفاده شد (۹16 پاکت حاوی واژه کنترل و ۹16 پاکت حاوی واژه مداخله ).
Parents and non-verbal autistic children aged 2 to 6 living in remote cities without proper rehabilitation facilities participate in this research. Subjects are randomly divided into intervention and control groups, and none of the parents know which study group they are in.
Parents and non-verbal autistic children aged 3 to 6 living in remote cities without proper rehabilitation facilities participate in this research. Subjects are randomly divided into intervention and control groups, and none of the parents know which study group they are in.
Parents and non-verbal autistic children aged 23 to 6 living in remote cities without proper rehabilitation facilities participate in this research. Subjects are randomly divided into intervention and control groups, and none of the parents know which study group they are in.
والدین و کودکان اتیسم ۲ تا ۶ ساله فاقد کلام ساکن در شهرستان های دور افتاده و فاقد امکانات توانبخشی مناسب در این پژوهش شرکت می کنند. آزمودنی‌ها با تصادفی سازی به دو گروه مداخله و کنترل تقسیم می‌شوند و هیچکدام از والدین نمیدانند که در کدام گروه مطالعه قرار دارند.
والدین و کودکان اتیسم 3 تا ۶ ساله فاقد کلام ساکن در شهرستان های دور افتاده و فاقد امکانات توانبخشی مناسب در این پژوهش شرکت می کنند. آزمودنی‌ها با تصادفی سازی به دو گروه مداخله و کنترل تقسیم می‌شوند و هیچکدام از والدین نمیدانند که در کدام گروه مطالعه قرار دارند.
والدین و کودکان اتیسم ۲3 تا ۶ ساله فاقد کلام ساکن در شهرستان های دور افتاده و فاقد امکانات توانبخشی مناسب در این پژوهش شرکت می کنند. آزمودنی‌ها با تصادفی سازی به دو گروه مداخله و کنترل تقسیم می‌شوند و هیچکدام از والدین نمیدانند که در کدام گروه مطالعه قرار دارند.
General information
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2023-01-30, 1401/11/10
2023-01-30 00:00:00
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2023-03-04, 1401/12/13
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2023-09-20, 1402/06/29
2023-09-20 00:00:00
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With respect, we remind you that at the time of registration of our trial in the Iranian Clinical Trials System (IRCT), our initial sample size, according to the study proposal, included 18 subjects. These people were supposed to be divided equally between two intervention and control groups, with 9 subjects in each group.
However, during the implementation of the intervention and data collection, due to the overwhelming response from families, we realized that we could expand our support to this disadvantaged population living in rural areas. Due to the lack of access of these families to face-to-face speech therapy interventions, we decided to include more eligible families in the study. As a result, the final sample size for our study increased to 32 subjects. To maintain statistical accuracy, we randomly divided these subjects into two study groups, each including 16 subjects. Therefore, please allow us to update the sample size for this trial.
Also, due to the participation of 3-6 year old children in this research, please allow the age range of the participants to be changed from 2-6 years to 3-6 years.
With respect, we remind you that at the time of registration of our trial in the Iranian Clinical Trials System (IRCT), our initial sample size, according to the study proposal, included 18 subjects. These people were supposed to be divided equally between two intervention and control groups, with 9 subjects in each group. However, during the implementation of the intervention and data collection, due to the overwhelming response from families, we realized that we could expand our support to this disadvantaged population living in rural areas. Due to the lack of access of these families to face-to-face speech therapy interventions, we decided to include more eligible families in the study. As a result, the final sample size for our study increased to 32 subjects. To maintain statistical accuracy, we randomly divided these subjects into two study groups, each including 16 subjects. Therefore, please allow us to update the sample size for this trial. Also, due to the participation of 3-6 year old children in this research, please allow the age range of the participants to be changed from 2-6 years to 3-6 years.
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با احترام، به استحضار می رساند که در زمان ثبت کارآزمایی ما در سامانه کارآزمایی های بالینی ایران (IRCT)، حجم نمونه اولیه ما طبق پروپوزال مطالعه، شامل 18 نفر بود. قراربود این افراد به طور مساوی بین دو گروه مداخله و کنترل، با 9 نفر در هر گروه تقسیم شوند.
با این حال، در زمان اجرای مداخله و جمع‌آوری داده‌ها، با توجه به استقبال چشمگیر خانواده ها، متوجه شدیم که می توانیم حمایت خود به این جمعیت محروم ساکن در مناطق روستایی را گسترش دهیم. با توجه به عدم دسترسی این خانواده ها به مداخلات گفتار درمانی چهره به چهره، تصمیم گرفتیم که خانواده‌های واجد شرایط بیشتری را به مطالعه وارد کنیم. در نتیجه، حجم نمونه نهایی برای مطالعه ما به 32 نفر افزایش یافت. برای حفظ دقت آماری، ما این افراد را به طور تصادفی به دو گروه مطالعه که هر کدام شامل 16 آزمودنی بودند، تقسیم کردیم. بنابراین، خواهشمندیم به ما اجازه دهید تا حجم نمونه برای این کارآزمایی به‌روزرسانی شود.
همچنین، با توجه به مشارکت کودکان 3 تا 6 ساله در این پژوهش، لطفا اجازه دهید که دامنه سنی شرکت کنندگان، از 2 تا 6 سال به 3 تا 6 سال تغییر یابد.
با احترام، به استحضار می رساند که در زمان ثبت کارآزمایی ما در سامانه کارآزمایی های بالینی ایران (IRCT)، حجم نمونه اولیه ما طبق پروپوزال مطالعه، شامل 18 نفر بود. قراربود این افراد به طور مساوی بین دو گروه مداخله و کنترل، با 9 نفر در هر گروه تقسیم شوند. با این حال، در زمان اجرای مداخله و جمع‌آوری داده‌ها، با توجه به استقبال چشمگیر خانواده ها، متوجه شدیم که می توانیم حمایت خود به این جمعیت محروم ساکن در مناطق روستایی را گسترش دهیم. با توجه به عدم دسترسی این خانواده ها به مداخلات گفتار درمانی چهره به چهره، تصمیم گرفتیم که خانواده‌های واجد شرایط بیشتری را به مطالعه وارد کنیم. در نتیجه، حجم نمونه نهایی برای مطالعه ما به 32 نفر افزایش یافت. برای حفظ دقت آماری، ما این افراد را به طور تصادفی به دو گروه مطالعه که هر کدام شامل 16 آزمودنی بودند، تقسیم کردیم. بنابراین، خواهشمندیم به ما اجازه دهید تا حجم نمونه برای این کارآزمایی به‌روزرسانی شود. همچنین، با توجه به مشارکت کودکان 3 تا 6 ساله در این پژوهش، لطفا اجازه دهید که دامنه سنی شرکت کنندگان، از 2 تا 6 سال به 3 تا 6 سال تغییر یابد.
Subjects are randomly divided into intervention and control groups. For the random allocation of the subjects, the following steps are taken: a) determining the total sample size (18 subjects) and assigning codes 1 to 18 for each child, b) assigning sheets containing the short name of the target group in proportion to the number of sample size in each group (9 sheets containing the title of control and 9 sheets containing the title of intervention), c) placing the sheets in non-transparent envelopes, d) Picking envelopes randomly by someone outside the research team.
Subjects are randomly divided into intervention and control groups. For the random allocation of the subjects, the following steps are taken: a) determining the total sample size (32 subjects) and assigning codes 1 to 32 for each child, b) assigning sheets containing the short name of the target group in proportion to the number of sample size in each group (16 sheets containing the title of control and 16 sheets containing the title of intervention), c) placing the sheets in non-transparent envelopes, d) Picking envelopes randomly by someone outside the research team.
Subjects are randomly divided into intervention and control groups. For the random allocation of the subjects, the following steps are taken: a) determining the total sample size (1832 subjects) and assigning codes 1 to 1832 for each child, b) assigning sheets containing the short name of the target group in proportion to the number of sample size in each group (916 sheets containing the title of control and 916 sheets containing the title of intervention), c) placing the sheets in non-transparent envelopes, d) Picking envelopes randomly by someone outside the research team.
آزمودنی‌ها با تصادفی سازی به دو گروه مداخله و کنترل تقسیم می‌شوند. برای تخصیص تصادفی آزمودنی ها مراحل ذیل طی می شود: الف) تعیین حجم نمونه کلی (18 نفر) و تخصیص کدهای 1 تا 18 برای هر کودک، ب) اختصاص برگه های حاوی نام اختصاری گروه هدف متناسب با تعداد حجم نمونه در هر گروه (9 برگه حاوی عنوان کنترل و 9 برگه حاوی عنوان مداخله)، ج) قرار دادن برگه ها در پاکت های غیرشفاف، د) برداشتن پاکت ها به طور تصادفی توسط فردی خارج از تیم تحقیق.
آزمودنی‌ها با تصادفی سازی به دو گروه مداخله و کنترل تقسیم می‌شوند. برای تخصیص تصادفی آزمودنی ها مراحل ذیل طی می شود: الف) تعیین حجم نمونه کلی (32 نفر) و تخصیص کدهای 1 تا 32 برای هر کودک، ب) اختصاص برگه های حاوی نام اختصاری گروه هدف متناسب با تعداد حجم نمونه در هر گروه (16 برگه حاوی عنوان کنترل و 16 برگه حاوی عنوان مداخله)، ج) قرار دادن برگه ها در پاکت های غیرشفاف، د) برداشتن پاکت ها به طور تصادفی توسط فردی خارج از تیم تحقیق.
آزمودنی‌ها با تصادفی سازی به دو گروه مداخله و کنترل تقسیم می‌شوند. برای تخصیص تصادفی آزمودنی ها مراحل ذیل طی می شود: الف) تعیین حجم نمونه کلی (1832 نفر) و تخصیص کدهای 1 تا 1832 برای هر کودک، ب) اختصاص برگه های حاوی نام اختصاری گروه هدف متناسب با تعداد حجم نمونه در هر گروه (916 برگه حاوی عنوان کنترل و 916 برگه حاوی عنوان مداخله)، ج) قرار دادن برگه ها در پاکت های غیرشفاف، د) برداشتن پاکت ها به طور تصادفی توسط فردی خارج از تیم تحقیق.
Recruitment centers
#1
Name of recruitment center - English: Daily educational and rehabilitation center for subjects with autism spectrum disorder
Name of recruitment center - Persian: مرکز روزانه آموزشی و توانبخشی افراد دارای اختلال طیف اتیسم
Full name of responsible person - English: Sara Purhafezi
Full name of responsible person - Persian: سارا پورحافظی
Street address - English: Chaharbisheh, Ansar St., daily educational and rehabilitation center for subjects with autism spectrum disorder
Street address - Persian: چهاربیشه، خیابان انصار، مرکز روزانه آموزشی و توانبخشی افراد دارای اختلال طیف اتیسم
City - English: Masjed Soleyman
City - Persian: مسجدسلیمان
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6491654849
Phone: +98 61 4322 8061
Fax:
Email: pwrhafzysara@gmail.com
Web page address:
Name of recruitment center - English: Daily educational and rehabilitation center for subjects with autism spectrum disorder
Name of recruitment center - Persian: مرکز روزانه آموزشی و توانبخشی افراد دارای اختلال طیف اتیسم
Full name of responsible person - English: Sara Purhafezi
Full name of responsible person - Persian: سارا پورحافظی
Street address - English: Daily Educational and Rehabilitation Center for Subjects with Autism Spectrum Disorder. Ansar St. Chaharbisheh.
Street address - Persian: چهاربیشه، خیابان انصار، مرکز روزانه آموزشی و توانبخشی افراد دارای اختلال طیف اتیسم
City - English: Masjed Soleyman
City - Persian: مسجدسلیمان
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6491654849
Phone: +98 61 4322 8061
Fax:
Email: pwrhafzysara@gmail.com
Web page address:
Name of recruitment center - English: Daily educational and rehabilitation center for subjects with autism spectrum disorder Name of recruitment center - Persian: مرکز روزانه آموزشی و توانبخشی افراد دارای اختلال طیف اتیسم Full name of responsible person - English: Sara Purhafezi Full name of responsible person - Persian: سارا پورحافظی Street address - English: Chaharbisheh,Daily Educational and Rehabilitation Center for Subjects with Autism Spectrum Disorder. Ansar St., daily educational and rehabilitation center for subjects with autism spectrum disorder Chaharbisheh. Street address - Persian: چهاربیشه، خیابان انصار، مرکز روزانه آموزشی و توانبخشی افراد دارای اختلال طیف اتیسم City - English: Masjed Soleyman City - Persian: مسجدسلیمان Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6491654849 Phone: +98 61 4322 8061 Fax: Email: pwrhafzysara@gmail.com Web page address:
Protocol summary
Study aim
Developing an educational video for parents and investigating its effectiveness on communication and play skills of non-verbal ASD children
Design
Clinical trial with control group, single blind, randomized, on 32 patients. For randomization, random selection of 32 envelopes containing one of the control and intervention words was used (16 envelopes containing the control word and 16 envelopes containing the intervention word).
Settings and conduct
Parents and non-verbal autistic children aged 3 to 6 living in remote cities without proper rehabilitation facilities participate in this research. Subjects are randomly divided into intervention and control groups, and none of the parents know which study group they are in.
Participants/Inclusion and exclusion criteria
Children's Inclusion criteria:
Having ASD and not having verbal communication
Not using face-to-face speech therapy services
Having normal vision, hearing and movement
Parents Inclusion criteria:
Having high speed internet access.
Not having psychiatric disorders such as major depression
Children's exclusion criteria:
Using face-to-face speech therapy services after entering the study.
Parents exclusion criteria:
Unwillingness to continue receiving the treatment program through telepractice.
Intervention groups
The intervention group receives DVDs containing educational videos and implements educational techniques for their ASD child by following the videos.
The control group does not use any type of speech therapy intervention and waits to receive the educational DVD.
Main outcome variables
Empowering parents to provide early evidence-based interventions to ASD children; facilitating the benefit of ASD children living in remote areas from evidence-based speech therapy interventions.
General information
Reason for update
With respect, we remind you that at the time of registration of our trial in the Iranian Clinical Trials System (IRCT), our initial sample size, according to the study proposal, included 18 subjects. These people were supposed to be divided equally between two intervention and control groups, with 9 subjects in each group.
However, during the implementation of the intervention and data collection, due to the overwhelming response from families, we realized that we could expand our support to this disadvantaged population living in rural areas. Due to the lack of access of these families to face-to-face speech therapy interventions, we decided to include more eligible families in the study. As a result, the final sample size for our study increased to 32 subjects. To maintain statistical accuracy, we randomly divided these subjects into two study groups, each including 16 subjects. Therefore, please allow us to update the sample size for this trial.
Also, due to the participation of 3-6 year old children in this research, please allow the age range of the participants to be changed from 2-6 years to 3-6 years.
Acronym
ASD
IRCT registration information
IRCT registration number:IRCT20180716040486N1
Registration date:2023-01-31, 1401/11/11
Registration timing:registered_while_recruiting
Last update:2024-03-19, 1402/12/29
Update count:1
Registration date
2023-01-31, 1401/11/11
Registrant information
Name
Hossein Rezai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3506
Email address
rezai-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-15, 1401/07/23
Expected recruitment end date
2022-12-20, 1401/09/29
Actual recruitment start date
2023-01-30, 1401/11/10
Actual recruitment end date
2023-03-04, 1401/12/13
Trial completion date
2023-09-20, 1402/06/29
Scientific title
Developing Instructional Video for Parents and Investigating its Effectiveness on Communication and Play Skills of Nonverbal Children with Autism Spectrum Disorders
Public title
educating parents of children with ASD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Based on the diagnostic criteria of DSMV, the child has ASD.
The child has the intention to communicate but uses unconventional means of communication (for example, directing the parent towards the requested object by pulling his hand or clothes or using his hand as a tool) to communicate.
The child does not use conventional non-verbal communication tools (gesture, eye contact, or non-verbal vocalizations) or speech to communicate.
Given play level, the child is in the stage of exploratory play and is not able to perform functional play.
Children of both intervention groups should not use face-to-face speech therapy services before entering the study.
The child should benefit from normal vision, hearing and movement status.
The parent has no previous experience of receiving Parent-Child Interaction Therapy (PCIT).
The parent has access to one of the smart communication devices (smartphones or tablets).
One of the messaging software with video call capability (preferably WhatsApp) must be installed on the parent's smart communication device.
The parent has access to one of the necessary electronic equipment for DVD playback (personal computer, laptop or DVD player) or suitable electronic tools for displaying video files in flash memory (TV or digital flash receiver).
The parent has access to ADSL internet with a bandwidth of 8 megabytes and above or preferably fourth generation mobile internet (4G).
The parent does not suffer from psychiatric disorders such as major depression.
Exclusion criteria:
Children's use of face-to-face speech therapy services after entering the study
Parents' unwillingness to continue the treatment program through telepractice.
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
18
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are randomly divided into intervention and control groups. For the random allocation of the subjects, the following steps are taken: a) determining the total sample size (32 subjects) and assigning codes 1 to 32 for each child, b) assigning sheets containing the short name of the target group in proportion to the number of sample size in each group (16 sheets containing the title of control and 16 sheets containing the title of intervention), c) placing the sheets in non-transparent envelopes, d) Picking envelopes randomly by someone outside the research team.
Blinding (investigator's opinion)
Single blinded
Blinding description
Parents were all blinded in regard to the group (intervention or control) they
had been allocated.
Placebo
Not used
Assignment
Parallel
Other design features
The intervention group is the parents who receive educational DVDs and implement therapeutic techniques for their children by following the educational videos. The control group are parents who do not use any type of speech therapy intervention and are waiting to receive this educational DVD.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۹۴۳۴۷۱
Approval date
2022-07-16, 1401/04/25
Ethics committee reference number
IR.TUMS.FNM.REC.1401.049
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorders (ASDs)
ICD-10 code
F84
ICD-10 code description
Pervasive developmental disorders
Primary outcomes
1
Description
mean communication frequency score in children
Timepoint
Measuring the mean score of children's communication frequency before the intervention, immediately after the end of the intervention and three months after the end of the intervention
Method of measurement
Video analysis
2
Description
mean score of all types of communication purposes in children
Timepoint
Measuring the mean score of children's communication purposes before the intervention, immediately after the end of the intervention and three months after the end of the intervention
Method of measurement
Video analysis
3
Description
mean score of using communication tools in children
Timepoint
Measuring the mean score of children's use of communication tools before the intervention, immediately after the end of the intervention and three months after the end of the intervention
Method of measurement
Video analysis
4
Description
mean score of functional play in children
Timepoint
Measuring the mean score of children's functional play before the intervention, immediately after the end of the intervention and three months after the end of the intervention
Method of measurement
Video analysis
5
Description
mean receptive vocabulary score in children
Timepoint
Measuring the children's mean receptive vocabulary score before the intervention, immediately after the end of the intervention and three months after the end of the intervention
Method of measurement
MacArthur-Bates Communicative Development Inventories -1
6
Description
mean expressive vocabulary score in children
Timepoint
Measuring the children's mean expressive vocabulary score before the intervention, immediately after the end of the intervention and three months after the end of the intervention
Method of measurement
MacArthur-Bates Communicative Development Inventories -1
7
Description
mean parent responsiveness score
Timepoint
Measuring the mean parent responsiveness score before the intervention, immediately after the end of the intervention and three months after the end of the intervention
Method of measurement
Video analysis
Secondary outcomes
1
Description
Parents' quality of life score
Timepoint
The time periods for measuring the parents' quality of life score are: at the beginning of the study (before the start of the intervention), immediately after the intervention and 3 months after the end of the intervention.
Method of measurement
World Health Organization Quality of Life (WHOQOL-BREF)
Intervention groups
1
Description
Intervention group: This group will receive a parent education DVD that contains 10 short educational videos that are dedicated to the following topics: 1) the nature of ASD and the challenge of parents in child treatment, 2) strengthening parents' motivation to participate in treatment, 3) turning the home space into an effective educational environment, 4) increasing the frequency of the child's communication, 5) following the child's desires, 6) strengthening the parents' responsiveness, 7) teaching the child to use non-verbal communication tools, 8) teaching joint attention, 9) Teaching the communication intentions of requesting and protesting to the child and 10) teaching the child functional games. In addition to receiving this educational DVD, the researcher will have a video call with the parents of the intervention group twice a week for 3 months to answer the parents' questions regarding the implementation of educational techniques.
Category
Rehabilitation
2
Description
Control group:Control group: Parents of the control group do not receive parental training DVDs until three months after the start of the study, and they do not use face-to-face speech therapy services for their autistic child. After the completion of the 12-week period of providing the intervention to the intervention group and conducting the post-intervention evaluations, the parent education DVD will be sent to this group as well, and the researcher will answer the parents' questions on the implementation of educational techniques through weekly video calls.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Daily educational and rehabilitation center for subjects with autism spectrum disorder
Full name of responsible person
Sara Purhafezi
Street address
Daily Educational and Rehabilitation Center for Subjects with Autism Spectrum Disorder. Ansar St. Chaharbisheh.
City
Masjed Soleyman
Province
Khouzestan
Postal code
6491654849
Phone
+98 61 4322 8061
Email
pwrhafzysara@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
https://vcr.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
Hossein Rezai
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Vice Chancellor for Research, Central University Organization, Corner of Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
https://www.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hooshang Dadgar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, Rehabilitation faculty, Tehran University of Medical Sciences: Pich. Shemiran, Enghelab St
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Email
hgdadgar@gmail.com
Web page address
https://rehab.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Rezai
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Department of Speech Therapy, Rehabilitation faculty, Tehran University of Medical Sciences, corner of Safi Alishah St, Pich Shemiran, Enghelab St
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
hosseynrezaai@gmail.com
Web page address
https://rehab.tums.ac.ir/
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
communication level
pragmatic skills
play level
receptive vocabulary
expressive vocabulary
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
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The applicant is only allowed to use the data for statistical analysis.
From where data/document is obtainable
Hossein Rezai: Department of Speech Therapy, Rehabilitation faculty, Tehran University of Medical Sciences, corner of Safi Alishah St, Pich Shemiran, Enghelab St
Mobile: 00989177773594
Email: hosseynrezaai@gmail.com
What processes are involved for a request to access data/document
To access the research data, please specify your affiliation and tell us how you are going to use the data? After reviewing your request, the data will be sent to you after three working days.