The purpose of the study is to determine the effect of remote health education on general health, sleep disorders and resilience of mothers of children with autism referred to autism centers in Shiraz.
Design
The clinical trial with control and intervention groups; with parallel design; double-blind; on 80 people; randomized by simple lottery method.
Settings and conduct
This research is conducted in Tabsem and Mehrandish Center of Shiraz. The studied population is mothers with children with autism. This study is double-blind because the mothers do not know which one is in the control group and which one is in the intervention group. Also, the person who analyzes the data does not know who is in the intervention and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to participate in the research; having an autism disorder for the child that has been approved by a psychiatrist; having the ability to read and write; having a smartphone and the ability to use communication software ; the ability to use virtual education.
Exclusion criteria: passing a similar training program; suffering from acute and chronic problems and mental disorders that prevent participation in training sessions; moving to another city.
Intervention groups
Intervention group: For the intervention group, 9 online sessions of 60 minutes will be held twice a week.
Control group: No intervention is done for the control group, and at the end of the study, electronic content is provided to them
Main outcome variables
General health, Sleep quality and Resilience In mothers with autistic children
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20160404027216N12
Registration date:2024-02-19, 1402/11/30
Registration timing:prospective
Last update:2024-02-19, 1402/11/30
Update count:0
Registration date
2024-02-19, 1402/11/30
Registrant information
Name
Fatemeh Vizeshfar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4258
Email address
vizeshfarf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-03-29, 1403/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of remote health education on general health, sleep quality and resilience of mothers of children with autism
Public title
The impact of distance health education on general health, sleep quality and resilience
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction with participation in research
Autism disorder in the child confirmed by a psychiatrist
Having at least reading and writing literacy
Having a smartphone and the ability to use communication software
Ability to use virtual training
Exclusion criteria:
Completing a similar training program
Suffering from acute and chronic problems and mental disorders that prevent participation in training sessions
Moving to another city
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Two centers are selected under the direct supervision of the welfare of the Statistical Society by a simple lottery method (in this way, the name of each center is written separately in the middle of the note sheet and folded on both sides. One University professors are asked to choose one of the leaves) the name of the center chosen as the first center in the lottery is allocated as the intervention group and the other center is allocated as the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because the questionnaire is given to all participants, no one knows that they are in the control and intervention groups. The person analyzing the data also does not know who is in the intervention and control group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences; next to Red Crescent institution; Zand street
City
Shiraz
Province
Fars
Postal code
84471-71946
Approval date
2024-01-09, 1402/10/19
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.114
Health conditions studied
1
Description of health condition studied
The subject of study is not a disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
General health score in Goldberg and Hiller general health questionnaire
Timepoint
Before the start of the intervention - immediately after the intervention - 2 months after the intervention
Method of measurement
Goldberg and Hiller general health questionnaire
2
Description
Sleep quality score in the Pittsburgh Sleep Quality Questionnaire
Timepoint
Before the start of the intervention - immediately after the intervention - 2 months after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
3
Description
Resilience score in Kenner and Davidson's resilience questionnaire
Timepoint
Before the start of the intervention - immediately after the intervention - 2 months after the intervention
Method of measurement
Kenner and Davidson's resilience questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, 9 online sessions of 60 minutes will be held twice a week. Topics include: two sleep hygiene sessions; three sessions of resilience and ways to create it; other sessions of self-awareness skills; empathy skills; self-expression skills; Problem solving skills
Category
Rehabilitation
2
Description
Control group: No intervention is done for the control group and electronic content is provided to them at the end of the study.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehrandish Autism Center
Full name of responsible person
Zohre Hassas
Street address
1 Alley; Shahid Haraf Street
City
Shiraz
Province
Fars
Postal code
7349171441
Phone
+98 71 3383 0214
Email
shiraz.autism.mehrandish@gmail.com
2
Recruitment center
Name of recruitment center
Tabsem Autism Rehabilitation and Training Center, Shiraz
Full name of responsible person
Zohre Karami
Street address
6 Alley; South Chehel Magham Blvd.
City
Shiraz
Province
Fars
Postal code
7349171321
Phone
+98 71 3231 9746
Email
zohre.karami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Central building of Shiraz University of Medical Sciences; in front of Felestin Street; Zand Street
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3481 4336
Email
info@sums.ac.ir
Grant name
research grant
Grant code / Reference number
10450
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Vizeshfar
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh Nursing and Midwifery School; Namazi Square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
vizeshfarf@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Vizeshfar
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh Nursing and Midwifery School; Namazi Square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
vizeshfarf@sum.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Vizeshfar
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh Nursing and Midwifery School; Namazi Square
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Phone
+98 71 3647 4254
Email
vizeshfarf@sums.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