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IRCT20211004052670N1 IRCT 2021-12-28 Esfahan University of Medical Sciences The efficacy of intranasal oxytocin before applied behavior analysis (ABA) therapy with autistic spectrum disorder The efficacy of intranasal oxytocin before applied behavior analysis (ABA) therapy of youth (4-17 years old) with autistic spectrum disorder 2022-01-15 anticipated 70 Complete https://irct.ir/trial/59222 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Autism. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Safie Shafiezadegan-Isfahani
No. 28, 7th Alley, 2nd Apadana Street
Isfahan Iran (Islamic Republic of) 8166783471 +98 31 3662 5950 ss.shafiezadegan70@gmail.com Esfahan University of Medical Sciences scientific Safie Shafiezadegan-Isfahani
No. 28, 7th Alley, 2nd Apadana Street
Isfahan Iran (Islamic Republic of) 8166783471 +98 31 3662 5950 ss.shafiezadegan70@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) autism 4-17 year old 4 years 17 years Both endocrine disease head thruma neurologic problem F84.0 Autistic disorder Treatment - Drugs Placebo 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. 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. 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). 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). Esfahan University of Medical Sciences Approved 2021-09-04 Ethics committee of Esfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Esfahan Isfehan Iran (Islamic Republic of)