Study to Compare Verbal Scores of Children Diagnosed With ASD Who Received Hyperbaric Treatment To Those Who Did Not

Oxford Recovery Center65 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Autism Spectrum Disorder

Interventions

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * History of seizure disorder * Diagnosis of genetic or mitochondrial mutation

Outcomes

Primary Outcomes

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.

Verbal testing: Verbal Behavior Milestones Assessment and Placement Program (VBMAPP)

Time frame: Change from baseline of verbal scores at 6 months

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.

Verbal testing: Assessment of Basic Language and Learning Skills (ABLLS).

Time frame: Change from baseline of verbal scores at 6 months

Secondary Outcomes

Number of participants with hyperbaric oxygen treatment related adverse events.

Adverse events were collected during every HBO session only for the treatment group subjects. All verbatim AE terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class (SOC) and, preferred term (PT) and study treatment.

Time frame: up to 30 weeks