The effect of drawing and storytelling attachment and sleeping habits in children with autism
Design
A clinical trial with a control group, with parallel groups, randomized , on 42 patients. For randomization, a randomized triple block without permutation (21 blocks of 6 out of 126 cases) was used.
Settings and conduct
After receiving a referral letter from Iran University of Medical Sciences, researchers refer to rehabilitation centers under the supervision of the university and start sampling
Participants/Inclusion and exclusion criteria
Inclusion criteria
Kid's age should be between 4 to 12 years
Definitive diagnosis of autism in a child
Family willingness to cooperate
Exclusion criteria:
The child has levels two and three with autism
Intervention groups
First, by obtaining the necessary permits, 42 people are randomly selected into three groups: painting intervention, storytelling and control intervention. Supervise the parent to start painting with the free subject. This intervention should be done at least 5 nights a week. In the storytelling group, the story was read to the child every night before bed and chosen by the parents. After one month, the questionnaire is filled out by the parents
Main outcome variables
Sleep habits
Attachment
General information
Reason for update
Acronym
autism
IRCT registration information
IRCT registration number:IRCT20141216020344N5
Registration date:2021-03-19, 1399/12/29
Registration timing:prospective
Last update:2021-03-19, 1399/12/29
Update count:0
Registration date
2021-03-19, 1399/12/29
Registrant information
Name
Hamidreza Khoshnezhad Ebrahimi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7787 2189
Email address
khoshnezhad.hr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of drawing and storytelling attachment and sleeping habits in children with autism
Public title
Effect of drawing and storytelling on autism
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Kid's age should be between 4 to 12 years
Definitive diagnosis of autism in a child
Family willingness to cooperate
Exclusion criteria:
The child suffers from levels two and three of autism
Age
From 4 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
N/A
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 Iran University of Medical Sciences
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Approval date
2020-11-30, 1399/09/10
Ethics committee reference number
IR.IUMS.REC.1399.940
Health conditions studied
1
Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Attachment
Timepoint
Before and one month after the start of the intervention
Method of measurement
Kinship Center Attachment Questionnaire
2
Description
Sleep
Timepoint
Before and one month after the start of the intervention
After receiving a referral letter from Iran University of Medical Sciences, researchers refer to rehabilitation centers under the supervision of the university and start sampling. At the beginning the, the objectives of the study are explained to the parents whose children participating in the study. In addition, written consent is obtained from all individuals to participate in the study. The pre-test is then completed through the Child Sleep Habits and Attachment Questionnaire. The intervention group is asked about this process: every night, if the child and family wish to do so, after dinner and before sleep rituals such as brushing the child, Start painting with the subject alone under the supervision of a mother or father. Then paint and then take the sheet from the office and stick it on the wall of the child's room next to the bed, so that the child can see them. This intervention is performed at least for 5 nights a week for a month. Each week, the family takes paintings of the wall and sends it to the researcher so that the researcher can be sure of the intervention process.
Category
N/A
2
Description
First, after receiving a letter of introduction from Iran University of Medical Sciences, they refer to the rehabilitation centers under the supervision of the university and start sampling. At the beginning of the study, the objectives of the study are explained to the parents of the children participating in the study. In addition, written consent is obtained from all individuals to participate in the study. The pre-test is then completed through the Child Sleep Habits and Attachment Questionnaire. The intervention group is asked about this process: every night, if the child and family wish to do so, after dinner and before sleep rituals such as brushing the child. If the child and the family want to do this, the story will be read to the child before going to bed and chosen by the parents. After one month, the questionnaire is completed by the parents
Category
N/A
3
Description
In the control group: interventions are not performed
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Medical Sciences Rehabilitation Center
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.acir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abbas Motavlian
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatric Emergency
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2041
Email
khoshnezhad.hr@iums.acir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.acir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Hamidreza Khoshnezhad Ebrahimi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Tehran, Modares Highway, after Mirdamad Bridge, Shahid Dastgerdi St. (Zafar), Hazrat Ali Asghar Children's Hospital
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2045
Email
khoshnezhad.hr@iums.acir
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
Data is encrypted in order to make individuals' identifiable and confidential
When the data will become available and for how long
From the end of sampling to 6 months after the publication of the article
To whom data/document is available
University Ethics Committee, Project Arbitration Committee, Article Arbitration Committee and other researchers
Under which criteria data/document could be used
Perform systematic review or meta-analysis by mentioning the document
From where data/document is obtainable
Dr Hamidreza Khoshnezhad Ebrahimi
What processes are involved for a request to access data/document
After submitting the application via academic email, we will provide the information files to the individuals within a maximum of one week.