Oxytocin in Adolescents With Autism Spectrum Disorders
This trial is active, not recruiting.
|Condition||autism spectrum disorder|
|Treatment||ocytocina - spray nasal|
|Phase||phase 2/phase 3|
|Sponsor||University of Sao Paulo General Hospital|
|Start date||November 2013|
|End date||July 2014|
|Trial size||30 participants|
|Trial identifier||NCT02007447, CAAE 10922213.7.0000.0068|
This study is design to evaluate the influence of oxytocin in some aspects of Autism Spectrum Disorder (ASD), such as, repetitive and stereotyped behavior, social skills, quality of life and disruptive behaviors.
Null hypothesis: social skills, quality of life, disruptive behaviors and repetitive behaviors do not improve with the use of oxytocin. Experimental Hypothesis: social skills, quality of life, disruptive behaviors and repetitive and stereotyped behaviors improve with the use of oxytocin.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: 8 weeks
time frame: 8 WEEKS
Male participants from 12 years up to 18 years old.
Inclusion Criteria: - Male - Age between 11 years 11 months and 17 years 11 months - Autism spectrum disorder according to DSM V - ADI > 10 - WISC > 70 - CARS > 30 Exclusion Criteria: - Female - presence of genetic and neurological syndromes - changes in drugs or in any intervention during the study
|Official title||Oxytocin in Adolescents With Autism Spectrum Disorders|
|Principal investigator||Helena P. Brentani, PHD|
|Description||Individuals with ASD have impaired social interaction, repetitive and disruptive behaviors. Oxytocin has been described to improve those skills and studies suggest that administration can reduce repetitive behaviors as well as enhance social interaction and communication deficits. This study is design to evaluate the influence of oxytocin in some aspects of Autism Spectrum Disorder (ASD), such as, repetitive and stereotyped behavior, social skills, quality of life and disruptive behaviors. Instruments: 1. Evaluation of social skills: Matson Evaluation of Social Skills (MESSY): consisting of 62 items divided into six factors that assess social skills such as appropriate social skills, assertiveness inadequate, impulsivity, self-confidence, jealousy withdraw, and other items that do not fit another classification. 2. Evaluation of repetitive behavior: Repetitive Behavior Scale (RBS): Consists of 43 items divided into six subscales: stereotyped behavior, self-harm behavior, compulsive behavior, ritualistic behavior, behavior monotonous and restricted behavior. This scale is able to measure the presence and severity of repetitive behaviors as common in individuals on the autism spectrum. 3. Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior 4. Multidimensional Student's Life Satisfaction Scale (MSLSS)|
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