The effects of home-based Yoga program on physical quality of life, Social behavior and Sleep Habits in children and adolescents with autism spectrum disorder and their parents( international study )
The effects of home-based Yoga program on quality of life, Social behavior and Sleep Habits in children and adolescents with autism spectrum disorder and their parents
Design
In this study, all the children who met the inclusion criteria, and who visited the autism spectrum disorders research center located in Hamedan, Iran are considered. Then, they are randomly divided into two groups (intervention and control). A block randomization method with a block size of four was used to randomize participants. The design will be parallel.
Settings and conduct
We will recruit children with autism syndrome aged 6–12 years from an autism spectrum disorders research center located in Hamedan, Iran. Then the participants will be randomly divided into two intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: a) having a child diagnosed with Autism syndrome, b) agreeing to participate in the study voluntarily and c) having an active WhatsApp account
Intervention groups
The intervention group will receive Yoga training for 8 weeks—3 times per week and 40 minutes each session. The control group will participate in their usual daily activity levels, without additional exercise.
Main outcome variables
Quality of life, Social behavior and Sleep Habits in children and adolescents with autism spectrum disorder and their parents
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170114031921N4
Registration date:2023-06-26, 1402/04/05
Registration timing:registered_while_recruiting
Last update:2023-06-26, 1402/04/05
Update count:0
Registration date
2023-06-26, 1402/04/05
Registrant information
Name
homa naderifar
Name of organization / entity
Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 6134
Email address
homa.naderifar@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of home-based Yoga program on physical quality of life, Social behavior and Sleep Habits in children and adolescents with autism spectrum disorder and their parents( international study )
Public title
effects of home-based Yoga program on quality of life, Social behavior and Sleep Habits in children and adolescents
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a child diagnosed with Autism syndrome
Agreeing to participate in the study voluntarily
having an active WhatsApp account.
Exclusion criteria:
Children who demonstrated comorbidities, including genetic syndromes
Children who have severe medical limitations or illness
Age
From 6 years old to 12 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
A block randomization method with a block size of four was used to randomize participants. For this purpose, four sheets of paper were prepared. On two sheets letter C (Control group), and on two sheets letter I (Intervention group) was written. The sheets were mixed together and then randomly drawn out one at a time for each participant without replacement until all four sheets were drawn. This method is repeated until all participants were randomized.
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
Before the intervention and after the intervention
Method of measurement
Peds-Quality of life for children
2
Description
Social behavior
Timepoint
Before the intervention and after the intervention
Method of measurement
Behavior Checklist
3
Description
Sleep Habits
Timepoint
Before the intervention and after the intervention
Method of measurement
Childrens Sleep Habit Questionnsire (CSHQ)
4
Description
Quality of life of parents
Timepoint
Before the intervention and after the intervention
Method of measurement
World Health Organization Quality of Life (Brief) for parents
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in the intervention group will receive yoga training for 8 weeks (3 times a week and each session is 40 minutes).Yoga program will involve pranayamas (yoga breathing techniques), loosening exercises, asanas (physical postures), chanting and yoga relaxation techniques .
Category
Rehabilitation
2
Description
Control group: People in this group have their routine daily activities.