Comparison of guilt and depression of parents with children with autism before and after desensitization with eye movements and reprocessing (EMDR), using finger movements and using the elite mobile health program in the experimental and control groups.
Comparison of guilt and depression of parents with children with autism before and after desensitization with eye movements and reprocessing in the two experimental groups.
Design
The clinical trial has two intervention groups and one control group in parallel. 90 people are randomly selected and placed in experimental and control groups (30 people in each group) using permutation blocks and software.
Settings and conduct
Desensitization with eye movements and reprocessing is performed in experimental groups in 3 sessions of 60 minutes. The desensitization of both experimental groups is the same in all but the fourth stage. In the fourth stage of experimental group 1, rapid and simultaneous movement of the therapist's finger is used, and in experimental group 2, the elite mobile health program is used. The study is performed at the Autism Center affiliated to Hamadan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Be literate; Do not have psychiatric illnesses; Only has one child with a definitive diagnosis autism spectrum disorder; There is no other disabled child in the family; Have visual health
Intervention groups
In this study, the technique of desensitization through eye movement and reprocessing (EMDR), which is used to treat some disorders and mental problems, is used.No intervention is performed for the control group.
Main outcome variables
ًGuilt feeling; Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170411033378N8
Registration date:2020-11-18, 1399/08/28
Registration timing:registered_while_recruiting
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Efat Sadeghian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
sadeghian_e@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Eye Movements Desensitization and Reprocessing on Guilt Feeling , Depression of Parents of Children with Autism Disorder
Public title
Eye Movements Desensitization and Reprocessing on Guilt Feeling , Depression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be literate
Do not have psychiatric illnesses
Only has one child with a definitive diagnosis autism spectrum disorder
There is no other disabled child in the family
Have visual health
Exclusion criteria:
Absence from more than two consecutive sessions during the intervention
Lack of cooperation during the treatment session
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
First, 90 parents of children with autism are selected according to the inclusion criteria. Then, for random allocation, 15 blocks of 6 AABBCC, AABCBC, AACBCB, ABCABC, BABCAC, ACBBCA will be prepared and placed in envelopes.In order of entry of the parents, one of the envelopes was selected at random and based on the obtained block, 6 patients will be assigned to three groups.
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 Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences., in front of People's Park, Shahid Fahmideh Blvd., Hamadan., Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2020-08-22, 1399/06/01
Ethics committee reference number
IR.UMSHA.REC.1399.487
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
Guilty score
Timepoint
Before the intervention, immediately after the intervention and 30 days after the intervention
Method of measurement
The Kogler and Jones guilt questionnaire
Secondary outcomes
1
Description
Depression score
Timepoint
Before the intervention, immediately after the intervention and 30 days after the intervention
Method of measurement
Short Form Back Depression Inventory
Intervention groups
1
Description
Intervention group: Intervention group 1: Desensitization technique through eye movement and reprocessing (EMDR) includes 8 steps: 1- History 2- Preparation 3- Evaluation 4- Desensitization using rapid and simultaneous movement of the therapist's finger 5 - Cognitive reconstruction or stabilization 6- Physical scan 7- Closing the session 8- Re-evaluation. Intervention group 2: Eye movement desensitization and reprocessing (EMDR) technique includes 8 steps: 1- History 2- Preparation 3- Evaluation 4- Desensitization using Elite mobile health program 5- Cognitive reconstruction or stabilization 6 - Physical scan 7- Closing the session 8- Re-evaluation.
Category
Behavior
2
Description
Control group: Does not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan autism disorder center
Full name of responsible person
Efat Sadeghian
Street address
Hamadan University of Medical Sciences., in front of People's Park, Shahid Fahmideh Blvd., Hamadan., Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr.Saeid Bashirian
Street address
Hamadan University of Medical Sciences., in front of People's Park, Shahid Fahmideh Blvd., Hamadan., Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences., in front of People's Park, Shahid Fahmideh Blvd., Hamadan., Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences., in front of People's Park, Shahid Fahmideh Blvd., Hamadan., Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences., in front of People's Park, Shahid Fahmideh Blvd., Hamadan., Iran.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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