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Most of our patients had no willingness to participate in the survey
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCYTOCINA - SPRAY NASAL | Active Comparator | OCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks |
|
| Placebo | Placebo Comparator | Placebo - twice per day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCYTOCINA - SPRAY NASAL | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| SOCIAL SKILLS | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| REPETITIVE BEHAVIOR | 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. | 8 WEEKS |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior | Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior | 8 WEEKS |
| Multidimensional Student's Life Satisfaction Scale (MSLSS) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helena P. Brentani, PHD | University of Sao Paulo General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute os Psychiatry, Clinical Hospital at São Paulo | São Paulo | 05043-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23480321 | Background | Tachibana M, Kagitani-Shimono K, Mohri I, Yamamoto T, Sanefuji W, Nakamura A, Oishi M, Kimura T, Onaka T, Ozono K, Taniike M. Long-term administration of intranasal oxytocin is a safe and promising therapy for early adolescent boys with autism spectrum disorders. J Child Adolesc Psychopharmacol. 2013 Mar;23(2):123-7. doi: 10.1089/cap.2012.0048. Epub 2013 Mar 12. |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| D066107 | Social Skills |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
Multidimensional Student's Life Satisfaction Scale (MSLSS): SCALE OF QUALITY OF LIFE
| 8 WEEKS |
| D001519 | Behavior |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |