Effects of Hyperbaric Oxygenation Therapy on Adaptive, Aberrant and Stereotyped Behaviors in Children With Autism
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 27, 2006
CompletedFirst Posted
Study publicly available on registry
November 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedMay 5, 2009
May 1, 2009
10 months
November 27, 2006
May 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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)
Secondary Outcomes (2)
Aberrant Behavior Checklist
Clinical Global Impression Scale
Interventions
Eligibility Criteria
You may qualify if:
- Autism diagnosis
- Access to CARD clinics as necessary for the study duration
- Caregiver commitment to completing 80 sessions in 10-15 weeks
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Autism and Related Disorders
Tarzana, California, 91356, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff Bradstreet, MD
ICDRC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 27, 2006
First Posted
November 29, 2006
Study Start
November 1, 2006
Primary Completion
September 1, 2007
Study Completion
December 1, 2007
Last Updated
May 5, 2009
Record last verified: 2009-05