Protocol summary

Study aim
Determining The effect of hippotherapy on behavioral problems and executive function in children with autism spectrum disorder
Design
The present study is a one-group intervention study (pre-test - post-test). In this study, considering the inclusion criteria and reviewing the medical records of children with autism in the Urmia Autism Association, 8 people will enter the intervention group.
Settings and conduct
Study place: Urmia Autism Association in collaboration with Aria Equestrian Club; No blinding was performed in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with a diagnosis of Autism Spectrum Disorder (ASD) in the medical record; Membership of Urmia Autism Association and having a medical record. Non inclusion criteria: Children who have a history of self harm or beating others or suicide; Children who have a history of violence against animals or fear of animals; Children who have underlying diseases in addition to autism (such as epilepsy, psychiatric illness); Children with a history of hippotherapy
Intervention groups
The equine therapy program lasts 10 sessions for 10 weeks. The duration of each session will be 60-45 minutes. At the beginning of the sessions; Explain the plans of the same session, change clothes, repeat the rules, read poetry at the gate and observe hygiene (including washing hands and face and combing hair) and in the last three sessions, say goodbye to the horse.
Main outcome variables
Rate of executive function; behavioral problems

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048511N1
Registration date: 2020-10-17, 1399/07/26
Registration timing: registered_while_recruiting

Last update: 2020-10-17, 1399/07/26
Update count: 0
Registration date
2020-10-17, 1399/07/26
Registrant information
Name
Faraz Tayyar-Iravanlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3383 3829
Email address
faraztayyar97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-06, 1399/07/15
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hippotherapy on behavioral problems and executive function in children with autism spectrum disorder
Public title
Hippotherapy effect in children with autism
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with a diagnosis of Autism Spectrum Disorder (ASD) in the medical record Membership of children in the Urmia Autism Association and having a medical record Age range of 8-12 years old No medical prohibition for children to attend educational sessions
Exclusion criteria:
Children who have a history of self-harm or alteration or suicide Children who have a history of violence against animals or fear of animals Children who have underlying diseases in addition to autism (such as epilepsy, hypertension, psychiatric illness, asthma, and other illnesses) Children with a history of hippotherapy
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 8
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Single group without control group before and after the intervention

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of school of Pharmacy and Nursing & Midwifery ; Shahid Beheshti University of Medic
Street address
No. 9, 6th Alley,third Davazdah Metri, Kowsar street, 8 Shahrivar street
City
Urmia
Province
West Azarbaijan
Postal code
5716846693
Approval date
2020-08-23, 1399/06/02
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.167

Health conditions studied

1

Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder

Primary outcomes

1

Description
Behavioral disorders score
Timepoint
The questionnaire is completed in two stages, the first stage at the beginning of the equine therapy sessions and before the intervention, the second stage at the end of the intervention and in the closing session by the parents.
Method of measurement
In this study, in addition to a questionnaire related to demographic information of children with autism, questionnair of behavioral disorders in children with autism spectrum (parent form) will be used to collect data.

2

Description
Executive functional behavior rating
Timepoint
The questionnair are completed in two stages, the first stage at the beginning of the equine therapy sessions and before the intervention, the second stage at the end of the intervention and in the closing session by the parents.
Method of measurement
In this study, in addition to a questionnaire related to demographic information of children with autism, questionnair of behavioral rating questionnaire of executive function will be used to collect data.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, the participants of the study are children aged 9-12 years old with autism who are members of the Urmia Autism Association and have inclusion criteria and also children and their families want their children to participate in this study. Horse therapy sessions will be performed with the treatment team (including handler, companion and therapist or equestrian instructor). The equine therapy program lasts 10 sessions over 10 weeks in which children will not only ride horses but also pet the horse before they will do horseback riding, talking to horses, walking with horses and visiting horse stables. The duration of each session will be 60-45 minutes. The things that will be done the same in each session are: at the beginning of the sessions; Explain the plans of the same session, change clothes, repeat the rules, read poetry at the gate and observe hygiene (including washing hands and face and combing hair) and in the last three sessions, say goodbye to the horse.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Autism Charity Association. Urmia Branch
Full name of responsible person
Saba Sabooni
Street address
3rd floor, Maaref building, Tarzi street, Imam street
City
Urmia
Province
West Azarbaijan
Postal code
5716846693
Phone
+98 44 3225 8031
Email
faraztayyar97@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi street, Yemen street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Fax
+98 21 2243 3455
Email
Intl_office@sbmu.ac.ir
Web page address
http://en.sbmu.ac.ir/index.jsp?siteid=256&fkeyid=&siteid=24&pageid=13079&siteid=256
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faraz Tayyar-Iravanlou
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Psychiatrics
Street address
No. 9; 6th alley; second 12-meter avenue; Kowsar street; 8 Shahrivar street
City
Urmia
Province
West Azarbaijan
Postal code
5716846693
Phone
+98 44 3383 3829
Email
faraztayyar97@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faraz Tayyar-Iravanlou
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Psychiatrics
Street address
No. 9; 6th alley; second 12-meter avenue; Kowsar street; 8 Shahrivar street
City
Urmia
Province
West Azarbaijan
Postal code
5716846693
Phone
+98 44 3383 3829
Email
faraztayyar97@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Faraz Tayyar-Iravanlou
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Psychiatrics
Street address
No. 9; 6th alley; second 12-meter avenue; Kowsar street; 8 Shahrivar street
City
Urmia
Province
West Azarbaijan
Postal code
5716846693
Phone
+98 44 3383 3829
Email
faraztayyar97@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
The whole data can be shared after making participants unrecognizable
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Study data only will be available for people working in academic institutions
Under which criteria data/document could be used
Research team members have access to information.
From where data/document is obtainable
Send an email to the responsible author at the following address: faraztayyar97@gmail.com
What processes are involved for a request to access data/document
Send an email to the responsible author at the following address: faraztayyar97@gmail.com
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