The efficacy of intranasal oxytocin before applied behavior analysis (ABA) therapy of youth (4-17 years old) with autistic spectrum disorder
Design
randomized, double-blinding clinical trial, with the parallel groups, Phase 3 on 70 patients
Settings and conduct
In this randomized double-blind clinical trial study, 70 autism patients referred to Isfahan Khorshid Hospital will be included in the study and randomly divided into 2 groups. One group will receive oxytocin and the other group will receive normal saline. Then the severity of autism and the strength and difficulties of patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
having autism disorder and not having endocrine disease and head thrauma and neurologic problem
Intervention groups
Autism patients are divided into two groups. Oxytocin spray will be prescribed for patients in the intervention group and normal saline spray will be prescribed for patients in the control group.
Main outcome variables
The severity of autism; The strength and difficulties
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211004052670N1
Registration date:2021-12-28, 1400/10/07
Registration timing:prospective
Last update:2021-12-28, 1400/10/07
Update count:0
Registration date
2021-12-28, 1400/10/07
Registrant information
Name
afsaneh karbasi amel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3641 1255
Email address
afsaneh_karbasi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-15, 1400/10/25
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of intranasal oxytocin before applied behavior analysis (ABA) therapy of youth (4-17 years old) with autistic spectrum disorder
Public title
The efficacy of intranasal oxytocin before applied behavior analysis (ABA) therapy with autistic spectrum disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
autism
4-17 year old
Exclusion criteria:
endocrine disease
head thruma
neurologic problem
Age
From 4 years old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The method is permuted block randomization. In this way, first using online software (sealedenvelope), a sequence of random numbers will be created and by the same software, the generated numbers will be divided into 7 blocks of 10. Which is an equal number in each block will be 5 items from the intervention group and 5 items from the control group. So by doing each block, 5 patients (equally) will be assigned to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Before starting the study, the spray containing oxytocin and normal saline is prepared by the pharmacist in similar containers, with the same color and smell, and is labeled with codes A and B and given to the researcher. And they prescribe them without knowing the type of each drug. Also, the Patient, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Esfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-09-04, 1400/06/13
Ethics committee reference number
IR.MUI.MED.REC.1400.442
Health conditions studied
1
Description of health condition studied
Autism
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Severity of autism
Timepoint
Before the intervention, the sixth week during the intervention and 6 weeks after the intervention
Method of measurement
Gilliam Autism Rating Scale (GARS)
2
Description
Strenght and Difficulties
Timepoint
Before the intervention, the sixth week during the intervention and 6 weeks after the intervention
Method of measurement
Strengths and Difficulties Questionnaire (SDQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, patients have been prescribed three puffs of oxytocin spray in each nostril (4 IU per puff). Before the spray and half an hour after the end of the spray, vital signs include body temperature, blood pressure, and heart rate. Patients will then undergo Applied Behavior Analysis (ABA) therapy intervention. Patients will be sprayed with ABA at intervals of one week and continuously for six weeks.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients have been prescribed three puffs of normal saline spray in each nostril (4 IU per puff). Before the spray and half an hour after the end of the spray, vital signs include body temperature, blood pressure, and heart rate. Patients will then undergo Applied Behavior Analysis (ABA) therapy intervention. Patients will be sprayed with ABA at intervals of one week and continuously for six weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Safie shafiezadegan Esfahani
Street address
Second Apadana Street
City
Esfahan
Province
Isfehan
Postal code
81666373116
Phone
+98 31 3641 1397
Fax
+98 31 3641 3880
Email
www.prbesfahan@gmail.com
Web page address
https://www.behzisti.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Fax
Email
dean@med.mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Safie Shafiezadegan-Isfahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 28, 7th Alley, 2nd Apadana Street
City
Isfahan
Province
Isfehan
Postal code
8166783471
Phone
+98 31 3662 5950
Email
ss.shafiezadegan70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Safie Shafiezadegan-Isfahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 28, 7th Alley, 2nd Apadana Street
City
Isfahan
Province
Isfehan
Postal code
8166783471
Phone
+98 31 3662 5950
Email
ss.shafiezadegan70@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Safie Shafiezadegan-Isfahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 28, 7th Alley, 2nd Apadana Street
City
Isfahan
Province
Isfehan
Postal code
8166783471
Phone
+98 31 3662 5950
Email
ss.shafiezadegan70@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