Effects of Hyperbaric Oxygenation Therapy on Adaptive, Aberrant and Stereotyped Behaviors in Children With Autism

• 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)

• Aberrant Behavior Checklist
• Clinical Global Impression Scale

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.

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.

Study duration: Two weeks baseline, 10-15 week acute phase, with 1- and 3-month follow-ups.

All participants will spend one hour per session in hyperbaric oxygen chambers, for a minimum of 6 and a maximum of 10 sessions per week. A total of 80 cycles of one hour compressions must be completed within 15 weeks for all participants

Treatment Group: Pressure and Frequency

• 1.3 atmosphere absolute (ATA)
• 24% oxygen
• One session = 1 hour
• Total of 80 cycles of one hour compressions must be completed within 15 weeks.

Placebo Group: Pressure and Frequency

• Close to ambient air pressure, but the chamber needs enough pressure to inflate: 1.05 to 1.1 atmosphere absolute (ATA)
• Room Air
• One session = 1 hour
• Total of 80 cycles of one hour compressions must be completed within 15 weeks.

Inclusion Criteria:

• Autism diagnosis
• Access to CARD clinics as necessary for the study duration
• Caregiver commitment to completing 80 sessions in 10-15 weeks

Exclusion Criteria:

• 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)