Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Controlled Study on the Clinical Effects of Hyperbaric Therapy in Autistic Children
Brief Summary: Autism is a neurodevelopmental disorder currently affecting as many as 1 out of 166 children in the United States. Autism is considered by many to be a permanent condition with little hope for improvement. Treatment for autism is centered on special schooling and behavioral therapy; medical science currently has little to offer. Recent research has discovered that some autistic individuals have decreased blood flow to the brain, evidence of gastrointestinal and brain inflammation, increased markers of oxidative stress, and a relative mitochondrial dysfunction. Hyperbaric oxygen therapy (HBOT) can compensate for decreased blood flow by increasing the oxygen content of plasma and body tissues and can even normalize oxygen levels in ischemic tissue. In addition, animal studies have shown that HBOT has potent anti-inflammatory effects and reduces oxidative stress. Furthermore, recent evidence demonstrates that HBOT increases the production of mitochondria and mobilizes stem cells from human bone marrow, which may aid recovery in neurodegenerative diseases. Based upon these findings, it is hypothesized that HBOT will improve symptoms in autistic individuals.

Our recent retrospective case series demonstrated that HBOT may improve symptoms in autistic children. We recently completed a prospective pilot trial using HBOT in 18 children which demonstrated significant clinical improvements in autistic children on several standardized scales. Most of the scales were parent-rated, although some were rated by teachers. However, parents were not blinded to the fact that their children received HBOT and evaluation of the children was through parent-rated scales, either of which could lead to bias. There was no placebo or control group. Therefore, the improvements found in this prospective study could have been due merely to chance or the natural development of the children. To determine if HBOT improves symptoms in autistic children, a double-blind controlled study is needed.


Options:
A: Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score (Baseline, 8 Weeks from baseline, and 20 Weeks from baseline)
B: Standardized Measures; In addition to the direct measures of behavior described above, standardized intelligence and adaptive assessments will be conducted prior to the initiation of HBOT. These will include:; ADI/ADOS; WPPSI-III (2-6 years) /WASI (6+ years); Vineland Adaptive Behavior Scale (VABS); Subjective Questionnaires; Aberrant Behavior Checklist; Clinical Global Impression; ATEC; Selected sections of the APEQ; BRIEF; Parenting Stress Index; Repetitive Behavior Scale; A side effect questionnaire; Thoughtful House Caregiver diary
C: Neurologic evaluation (2 and 4 months)
D: Blinded Therapist Autism Diagnostic Observation Schedule (ADOS); Blinded Therapist Aberrant Behavior Checklist (ABC-C); Blinded Physician Clinical Global Impression Severity Score (CGI); Parental Autism Treatment Evaluation Checklist (ATEC)

Answer: D