The effect of emotions label training in autism children with high-function on their quality of life and mother-child relation.
Design
This study is a single-group and targeted sampling. The number of samples is 5 high-function autistic children. Intervention will have 2 general phases. Basic phase and test phase. The first phase will be without intervention and only the questionnaires will be completed, and the second phase will be in two stages, and the Lets Face It educational software and emotions labeling will be taught.
Settings and conduct
One of The autism schools in Tehran city- first phase will be without intervention and only the questionnaires will be completed, and the second phase will be in two stages, and the Lets Face It educational software and the emotions labeling will be taught.
Participants/Inclusion and exclusion criteria
Having high-performance autism -Ability to respond to linguistic instructions -Calendar age between 8-12 years -Mental Intelligence above 80 -No training for emotional control - Mother and child tendency to participate in the study / lack of vision and hearing problem
Intervention groups
Includes two phases of software training and emotion labeling.
Main outcome variables
Quality of life; Mother-Child Relationship
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180429039464N4
Registration date:2019-02-19, 1397/11/30
Registration timing:retrospective
Last update:2019-02-19, 1397/11/30
Update count:0
Registration date
2019-02-19, 1397/11/30
Registrant information
Name
Marzieh Hasanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4413
Email address
m-hasanpour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-26, 1397/10/05
Expected recruitment end date
2019-01-12, 1397/10/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of emotions label training to Autism children with high-function on their Quality of life and Mother-Child Relation
Public title
Effect of emotions label training in Autism children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having Autism with high-function
be able react to Language instructions
age in 8-12 years
IQ upper than 80
Not having emotions control training
Mother and child desire to participate in intervention
No having vision and hearing problems
Exclusion criteria:
Having moderate autism
History of non-collaboration with a researcher in previous studies
The accompanying illnesses disrupt the normal life situation
Age
From 8 years old to 12 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
5
Actual sample size reached:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This study is done with the single-subject design, according to different sources, the number of samples is between 2-10 and without computational formulas, as well as these types of designs are single-grouped and to study the effect of different education in children Autism has many uses in and out of the country.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Science
Street address
Faculty of Nursing & Midwifery, East Norsrat(Mirkhani) St, Enghelab St
City
Tehran
Province
Tehran
Postal code
45718-74496
Approval date
2018-08-29, 1397/06/07
Ethics committee reference number
IR.TUMS.FNM.REC.1397.089
Health conditions studied
1
Description of health condition studied
Autism with high-function
ICD-10 code
F84.5
ICD-10 code description
Asperger's syndrome
Primary outcomes
1
Description
Quality of life in children with High Function Autism
Timepoint
Questionnaire will be measured three, two and one weeks before the test, as well as the first day of the test, two weeks after the start of the test and the final day of the test
Method of measurement
Children's Quality of Life Questionnaire (PedsQl)
2
Description
Mother-child relation in autism children with high-function
Timepoint
Questionnaire will be measured three, two and one weeks before the test, as well as the first day of the test, two weeks after the start of the test and the final day of the test
Method of measurement
Mother-child relation questionnaire (MCRE)
Secondary outcomes
empty
Intervention groups
1
Description
Lets Face It (LFI) Educational Software Training performance: This software will be taught for each child for 3 hours and 15 hours total. In this way, the software is trained by a Lap Top devise in the presence of child's instructor in an appropriate room, and the score will be recorded after the game is completed. Emotions label performance: Test will include 3 happy, sadness and nervousness emotion cards and 40 situation cards related to these emotional states and include of 2 steps. At each stage, all children, a child instructor and researcher will be in the room. 1- several emotional situations cards will be placed on the board. Then an emotional card will be given to one of the children in random and will be asked to identify the associated emotional state from the cards on the board. Then the emotions situation cards are replaced and the emotional card will be changed, and the same process will be implemented for the next child. َ2- In reverse of previous step, emotion cards will place on board and request from child to find the emotional situation related to it. Each step is performed in 3 rounds and each round consist of 40 tests for each child. All emotions label training will be performed within 30 hours. Each child is trained for 6 hours in total.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Peyk Honar School of Autism
Full name of responsible person
Mrs Zeinab Chavosh Zadeh
Street address
44 west st, Kalantary Square, Yosef Abad
City
Tehran
Province
Tehran
Postal code
58159-65849
Phone
+98 21 8803 8549
Email
PeykHonarAutismSchool@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kardan Moghadam
Street address
Room No 604, Floor 6, Central Building of Tehran University of Medical Sciences, Corner of Ghods Street, Keshavarz Blvd
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
Dr Marzieh Hasanpour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery of Tehran, Mirkhani St, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4413
Email
m-hasanpour@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Marzieh Hasanpour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery of Tehran, Mirkhani St, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4413
Email
m-hasanpour@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Marzieh Hasanpour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery of Tehran, Mirkhani St, Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4413
Email
m-hasanpour@sina.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available