Effects of Hyperbaric Oxygenation Therapy on Adaptive, Aberrant and Stereotyped Behaviors in Children With Autism
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Direct Behavioral Observations
研究概览
简要总结
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 and other developmental disabilities.
详细描述
Positive treatment effects of HBOT have been reported in a number of studies, while others have found no demonstrable effect. Studies to date have evaluated effects on a variety of conditions, and utilized diverse research methods and generally await replication. Despite its increasing usage in children with autism, and the preliminary anecdotal reports indicating positive outcome, there is a paucity of well-controlled studies of HBOT in this population, which precludes clinicians from recommending and/or implementing it as an evidence-based treatment. It is clearly important therefore, to evaluate carefully the treatment effects of HBOT using robust research designs in this population.
Hypotheses
- Hyperbaric Oxygenation Therapy will be associated with a positive effect on symptoms of autism.
- Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at follow-up.
Specific Aims
- Evaluate the effects of Hyperbaric Oxygenation Therapy on behavioral and cognitive symptoms of autism before, during, and after treatment.
- Determine the percentage of children with autism who respond positively to 80 HBOT treatment cycles and the extent to which they do so.
- Determine the extent to which any observed treatment effects are maintained up to three months after HBOT.
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
- Double
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autism diagnosis
- •Access to CARD clinics as necessary for the study duration
- •Caregiver commitment to completing 80 sessions in 10-15 weeks
排除标准
- •Any prior treatment with HBOT
- •New dietary treatment within 3 months prior to enrollment,
- •New biomedical treatment within 3 weeks prior to enrollment
- •Inadequate vision or hearing for the purposes of test administration
- •Non-ambulatory or require more than minimum support walking
- •Unstable medical disorder
- •History of, or current seizure disorder
- •History of, or current asthma
- •History of, or current pulmonary cysts
- •History of, or current emphysema
- •History of, or current severe claustrophobia
- •Current otitis media
- •Current sinus infection
- •Current upper respiratory tract infection (URTI)
结局指标
主要结局
Direct Behavioral Observations
The Vineland Adaptive Behavior Scales: Expanded Edition (VABS)
Peabody Picture Vocabulary Test (PPVT)
Test of Visual-Perceptual Skills (TVPS)
The Beery-Buktenica Developmental Test of Visual-Motor Integration (VMI)
Autism Diagnostic Observation Schedule (ADOS)
The Behavior Rating Inventory of Executive Functioning (BRIEF)
次要结局
- Aberrant Behavior Checklist
- Clinical Global Impression Scale