Autism Spectrum Disorder
Conditions
Keywords
autism, oxytocin, autism spectrum disorder, social skills.
Brief summary
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.
Detailed 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)
Interventions
DRUGOCYTOCINA - SPRAY NASAL
The initial sample is divided into two groups (A and B): group A receive oxytocin intranasal for 8 weeks 24UI twice a day (3 applications per nostril 4UI 12/12 hours); group B will receive placebo for 8 weeks
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SOCIAL SKILLS | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| REPETITIVE BEHAVIOR | 8 WEEKS | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior | 8 WEEKS | Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior |
| Multidimensional Student's Life Satisfaction Scale (MSLSS) | 8 WEEKS | Multidimensional Student's Life Satisfaction Scale (MSLSS): SCALE OF QUALITY OF LIFE |
Countries
Brazil
Outcome results
None listed