Effects of Hyperbaric Oxygen Therapy on Behavioral Measures of Short Term Memory, Learning, and Behavior in Children With Autism
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Aberrant Behavior Checklist
研究概览
简要总结
PURPOSE
The purpose of this investigation is to evaluate the cognitive and behavioral effects of Hyperbaric Oxygenation Therapy in children who present with a diagnosis of autism spectrum disorder.
HYPOTHESIS
- Hyperbaric Oxygenation Therapy will be safe to use with children with autism.
- Hyperbaric Oxygenation Therapy will have a statistically significant effect on the symptoms of autism.
- Hyperbaric Oxygenation Therapy will have a clinically significant observable effect on the overt symptoms of autism.
- The decreases in the symptoms of autism will correlate positively with the number of Hyperbaric Oxygenation Therapy sessions.
- Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at follow-up, post 40 treatment sessions.
SPECIFIC AIMS
- Provide further evidence for the safety of Hyperbaric Oxygenation Therapy in children with autism.
- To quantitatively assess the effects of Hyperbaric Oxygenation Therapy on behavioral and cognitive symptoms of autism before, during, and after treatment.
- Identify number of treatments required to reach therapeutic effects.
- Identify the length and durability of treatment effect and maintenance.
详细描述
Participants & Setting
Participants in this study will be 30 consecutive children referred to Thoughtful House for the treatment of autism or a related developmental disorder. Participants may or may not also be concurrently receiving intensive behavioral intervention services from the Center for Autism and Related Disorders. All therapy and behavioral testing sessions will occur on the premises of Thoughtful House.
Inclusion Criteria
The following criteria will be considered inclusionary:
- Male and female children 2-10 years diagnosed with autism, PDD, or Aspergers
- No anticipated changes in treatment for the study duration (e.g., diet, nutrients)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female children 2-10 years diagnosed with autism, PDD, or Aspergers
- •No anticipated changes in treatment for the study duration (e.g., diet, nutrients)
- •No additional biomedical treatments started 6 weeks prior to enrollment
- •No changes in dietary management for 3 months prior to enrollment
- •Access to Thoughtful House on a daily basis, or as necessary for the study participation
- •In addition, the child participant must be:
- •Ambulatory or require minimum support walking, per parent
- •Able to sit still for 5 minutes or longer with a preferred toy item, per parent
- •Adequate vision and hearing for the purposes of test administration, per parent
- •Adequate arm-hand-finger coordination (i.e., able to point) for learning and cognitive tasks used in outcome measurement, per parent
- •Stable and controlled medical disorder
- •Under the care of a caregiver willing to participate by attending regularly scheduled appointments and completing the necessary measures
排除标准
- 未提供
结局指标
主要结局
Aberrant Behavior Checklist
Clinical Global Impression
ATEC
Selected sections of the APEQ
BRIEF
Parenting Stress Index
Repetitive Behavior Scale
Standardized Measures
In addition to the direct measures of behavior described above, standardized intelligence and adaptive assessments will be conducted prior to the initiation of HBOT. These will include:
ADI/ADOS
WPPSI-III (2-6 years) /WASI (6+ years)
Vineland Adaptive Behavior Scale (VABS)
Subjective Questionnaires
A side effect questionnaire
Thoughtful House Caregiver diary
次要结局
未报告次要终点