Oxytocin in Adolescents With Autism Spectrum Disorders
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- SOCIAL SKILLS
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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.
- Evaluation disruptive behavior: Vineland, just the part that assess disruptive behavior
- Multidimensional Student's Life Satisfaction Scale (MSLSS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 11 years 11 months and 17 years 11 months
- •Autism spectrum disorder according to DSM V
- •ADI > 10
- •WISC > 70
- •CARS > 30
排除标准
- •presence of genetic and neurological syndromes
- •changes in drugs or in any intervention during the study
研究组 & 干预措施
OCYTOCINA - SPRAY NASAL
OCYTOCINA - SPRAY NASAL - 24Ui twice per day for 8 weeks
干预措施: OCYTOCINA - SPRAY NASAL (Drug)
Placebo
Placebo - twice per day for 8 weeks
干预措施: OCYTOCINA - SPRAY NASAL (Drug)
结局指标
主要结局
SOCIAL SKILLS
时间窗: 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.
次要结局
- REPETITIVE BEHAVIOR(8 WEEKS)
研究者
Helena Paula Brentani
Helena Paula Brentani
University of Sao Paulo General Hospital