determining the effect of quality of life therapy on quality of life and behavioral disorders in mothers with autistic children
Design
Classical experimental (two-group pre-test - post-test) with a control group, with crossed groups, randomized, on 60 participating mothers who met the study entry criteria. A table of random numbers will be used for randomization
Settings and conduct
By receiving a letter of introduction from the university officials and receiving the code of ethics and obtaining permission from the respected officials of the Oghok Clinic in Gonbad Kavus city and providing information and research objectives will be explained to them according to the protocol. Informed consent will be obtained from the mothers of autistic children and the intervention protocol will be fully explained to the mothers.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Mastery of Persian language
Children aged 6-13 with autism
Willingness to cooperate with parents and participate in research
Exit criteria:
Absence of more than 4 sessions
Migration of children from the city
Intervention groups
In the treatment protocol intervention group, the quality of life intervention will be done with 8 treatment sessions and each session will last 90 minutes, and the control group will be given a questionnaire. There is no intervention
Main outcome variables
Quality of life, behavioral disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230311057685N1
Registration date:2023-05-03, 1402/02/13
Registration timing:registered_while_recruiting
Last update:2023-05-03, 1402/02/13
Update count:0
Registration date
2023-05-03, 1402/02/13
Registrant information
Name
Sonayaz Hivehchi
Name of organization / entity
The university of aliabad e katoul
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 8143
Email address
hivehchi@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-19, 1402/01/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: effect of quality of life therapy on quality of life and behavioral disorders in mothers with autistic children
Public title
: effect of quality of life therapy on quality of life and behavioral disorders in mothers with autistic children
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
persion language
Autistic children aged 6 to 13
Willingness to cooperate with parents and participate in research
Exclusion criteria:
Healthy children
Mothers with mental illnesses
Adults
Age
From 6 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The study subjects will be divided into 2 control and intervention groups by using simple randomization method and random number table. First, each person is assigned a number. Then, using the table of random numbers, each selected number is randomly assigned to one of the groups, and this work continues until the number of people in each group is completed. Therefore, the researcher will not have the authority to change the assignment status of people or predict it.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of aliabad e katool
Street address
no 3 .sorosh 12 Ave.naharkhoran Blvd.gorgan Town
City
Gorgan
Province
Golestan
Postal code
4917935965
Approval date
2023-03-01, 1401/12/10
Ethics committee reference number
IR.IAU.AK.REC.1401.005
Health conditions studied
1
Description of health condition studied
autism
ICD-10 code
F84. 0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
World Health Organization quality of life score (BREF-QOL WHO)
Timepoint
2 month
Method of measurement
World Health Organization Quality of Life Questionnaire
2
Description
The child's behavior questionnaire score in the Achenbach questionnaire
Timepoint
2 months
Method of measurement
Achenbach child behavior questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: In the intervention group, the quality of life intervention therapy protocol, which is based on the protocol adopted from the book of psychotherapy based on improving the quality of life of Farish (2006), will be conducted with 8 treatment sessions and each session will last 90 minutes for 2 months. The content of the training includes the definition of quality of life therapy, the introduction of dimensions of quality of life, the introduction of sixteen areas of life that make up the overall quality of a person's life, the discovery of problematic issues for members, a summary of the discussion, providing feedback, introducing CASIO as the five roots for increasing life satisfaction, Education will be the principles of quality of life.
Category
Lifestyle
2
Description
Control group: The control group will be given a questionnaire and no intervention will be done.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ofogh cilinic center of autism
Full name of responsible person
Abdolrahman Ofogh
Street address
Khorramshahr Ave
City
Gonbade Qavoos
Province
Golestan
Postal code
4917935965
Phone
+98 17 3423 9780
Email
sonayazhivehchi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The university of Aliabade Katool
Full name of responsible person
Nafiseh Hekmatipoor
Street address
Pasdaran Ave
City
Aliabad Katool
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Email
ravabet@aliabadiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of Aliabade Katool
Proportion provided by this source
100
Public or private sector
Private
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
The University of Aliabad Katool
Full name of responsible person
Nafiseh Hekmatipoor
Position
َAssociate professor
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sorosh Ave
City
Gorgan
Province
Golestan
Postal code
4917935965
Phone
00981732
Email
sonayazhivehchi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sonayaz Hivehchi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sorosh Ave
City
Gorgan
Province
Golestan
Postal code
4917935965
Phone
00981723
Email
hivehchi@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sonayaz Hivehchi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sorosh Ave
City
Gorgan
Province
Golestan
Postal code
4917935965
Phone
00981723
Email
sonayazhivehchi@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
no more data
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
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