Investigating the effect of educational training for educable mentally retarded children on reducing the burden of caring for their parents
Design
The clinical trial has a control group, randomized on 30 patients. Lottery was used for randomization.
Settings and conduct
This research is conducted in the educational and rehabilitation center for mentally retarded children in Pakdasht city and on 30 people, and no blinding will be done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Boys and girls under the age of 14 years old with mental retardation; Filling the informed consent form to participate in research therapy sessions;
Having the cooperation in completing the questionnaires.
Non-inclusion criteria:
Children whose intellectual performance level is not trainable, for example trainable, supportable, borderline, etc;
Parents who have more than one mentally retarded child
Intervention groups
Intervention group: They will be trained for 3 hours a day for 6 months. Control group: in the control group, there will be no intervention and they will be on the waiting list.
Main outcome variables
Parental care burden pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220708055417N1
Registration date:2022-09-11, 1401/06/20
Registration timing:retrospective
Last update:2022-09-11, 1401/06/20
Update count:0
Registration date
2022-09-11, 1401/06/20
Registrant information
Name
elahe dolat abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3603 4379
Email address
mohamadmahdi9566@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-01, 1401/05/10
Expected recruitment end date
2022-08-01, 1401/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational Training on Mentally Retarded Children to Reduce the Burden of Caring for Their Parents
Public title
Investigating the Effect of Educational Training of Intellectually Disabled Children on Their Parents
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Filling the informed consent form to participate in research therapy sessions
Having the cooperation of people in completing the questionnaires
Boys and girls under the age of 14 years old with mental retardation
Not having vision and hearing problems
Not having autism and hyperactivity disorder
Parents participating in the research therapy sessions not being treated by a psychiatrist or a clinical psychologist
Exclusion criteria:
Children whose intellectual performance level is not trainable, for example trainable, supportable, borderline, etc
Parents who have more than one mentally retarded child
Age
From 6 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, it is a semi-experimental type of research, and the sampling method in this research is selected in the available way and assigned in a simple random way. In such a way that all the members of the statistical community will have an equal chance to be selected, this selection is done using the lottery method. In this way, the numbers of each of these beneficiaries are put in a bag and then they are taken out one by one until the desired number of the sample is obtained. The sample size in this research will include 30 people who will be randomly divided into two groups of 15 people. and will be used randomly in such a way that one group will be selected as the experimental group and one group will be selected as the control group
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 Islamic Azad University, Semnan branch
Street address
Islamic Azad University Semnan branch, Shahrak Daneshgahi, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Approval date
2022-06-22, 1401/04/01
Ethics committee reference number
IR.IAU.SEMNAN.REC.1401.018
Health conditions studied
1
Description of health condition studied
The Effectiveness of Academic training educable mentally retarded children in reducing the burden of caring for their parents
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of care burden pressure of parents with mentally retarded children
Timepoint
Measurement of parental care burden after 1 month and 2 months
Method of measurement
Questionnaire of Zarit et al
Secondary outcomes
1
Description
The score of reduction of care burden pressures of parents with mentally retarded children
Timepoint
Measuring the care burden of parents with mentally retarded children after 1 month and 2 months
Method of measurement
Questionnaire of Zarit et al
Intervention groups
1
Description
Intervention group: intervention will takes place in an educational and rehabilitation center in Pakdasht city according to an educational protocol including basic and preliminary education including: familiarization with the surrounding environment, instructor and classmates for two to five days, individual skills training for one to six months, skills training Social manners one to three months, training to increase accuracy and attention and concentration and eye and hand coordination six months to one year, color training two months to one year, calligraphy and painting training six months to one year, memory strengthening training six months to One year, math training takes six months to one year and physical and mental training for one year.
Category
Treatment - Other
2
Description
Control group: no intervention is done for the control group. Before the intervention a Pre-test was taken from the control group and they were put on the waiting list. At the end of the intervention, they will be given a post- test and the result will be analyzed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Padideh educational and rehabilitation center
Full name of responsible person
Ameneh Haji Mazdarani
Street address
No. 33; Shahid Ali Qomi Alley; Moradi Street; Motehari street
City
Pakdasht
Province
Tehran
Postal code
3391655755
Phone
+98 21 3604 2276
Email
Padidehr344@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hengame Bidogkti
Street address
Islamic Azad University, Semnan Branch, Daneshgahi Town, Semnan
City
Semnan
Province
Semnan
Postal code
3513137111
Phone
+98 23 3365 4040
Fax
+98 23 3365 4036
Email
mohamadmahdi9566@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
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
Full name of responsible person
Elahe Dolatabadi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
3rd floor, No. 5, Fadak 3 alley, 20 Meteri Meqdad
City
Pakdasht
Province
Tehran
Postal code
3391845775
Phone
+98 21 3603 4379
Email
mohamadmahdi9566@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elahe Dolatabadi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
3rd floor, No. 5, Fadak 3 alley, 20 Meteri Meqdad
City
Pakdasht
Province
Tehran
Postal code
3391845775
Phone
+98 21 3603 4379
Email
mohamadmahdi9566@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elahe Dolat abadi
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
3rd floor, No. 5, Fadak 3 alley, 20 Meteri Meqdad
City
Pakdasht
Province
Tehran
Postal code
3391845775
Phone
+98 21 3603 4379
Fax
Email
mohamadmahdi9566@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD