A Retrospective Study to Evaluate Verbal Scores of Children Diagnosed With Autism Spectrum Disorder Who Received Hyperbaric Treatment and Those Who Did Not Receive Hyperbaric Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- The verbal scores will be measured for children with autism who underwent hyperbaric oxygen therapy and compared to those who did not by an age appropriate assessment.
研究概览
简要总结
A child's ability to effectively communicate with peers, parents, and caregivers impacts their level of independence and quality of personal relationships. This retrospective study will compare the speech development of participants aged 2 - 17 years that received 40 sessions of HBOT at 2.0 ATA to those who had not. Both groups will have a verbal assessment every six months. There were 32 subjects in the HBO group and 33 subjects in the non-HBO group. The statistical analysis will focus on whether Hyperbaric Oxygen Therapy made a significant difference in Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) or Assessment of Basic Language and Learning Skills (ABLLS) results.
详细描述
Methods: This was a study designed to retrospectively determine any association between hyperbaric oxygen therapy (HBOT) and change in verbal scores in children with autism spectrum disorder (ASD). All children aged 2 to 17 years, diagnosed with ASD who completed a verbal test every six months (either Verbal Behavior Milestones Assessment and Placement Program or the Assessment of Basic Language and Learning Skills), received applied behavioral analysis at Oxford Recovery Center (ORC) were screened for inclusion, some of whom had elected to receive HBOT (at least 40 sessions for 60 minutes at 2.0 ATA).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with autism spectrum disorder by a qualified practitioner
- •Obtained medical clearance for hyperbaric oxygen therapy
- •Received applied behavioral analysis at Oxford Recovery Center
- •Received two of the same age appropriate verbal test 6 months apart
排除标准
- •History of seizure disorder
- •Diagnosis of genetic or mitochondrial mutation
结局指标
主要结局
The verbal scores will be measured for children with autism who underwent hyperbaric oxygen therapy and compared to those who did not by an age appropriate assessment.
时间窗: Change from baseline of verbal scores at 6 months
Verbal testing: Verbal Behavior Milestones Assessment and Placement Program (VBMAPP)
The verbal scores will be measured for children with ASD who underwent hyperbaric oxygen therapy and compared to the those who did not using an age appropriate assessment.
时间窗: Change from baseline of verbal scores at 6 months
Verbal testing: Assessment of Basic Language and Learning Skills (ABLLS).
次要结局
- Number of participants with hyperbaric oxygen treatment related adverse events.(up to 30 weeks)
研究者
Tami Peterson PhD
Principal Investigator
Oxford Recovery Center