Essential Oils for Enhancing QOL in ASD

Pediatric Quality of Life Inventory (PedsQL) (Varni, Burwinkle, & Seid, 2006). The Generic PedsQL Inventory is a caregiver-rated scale for children ages 2-12. The PedsQL Inventory for 2-4 year old children includes 21 items. The PedsQL Inventories for 5-12 year old children include 23-items. The PedsQL Inventories were designed to measure the core domains of health and their impact on the quality of life in children as outlined by the World Health Organization. The four sub-scales are Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. The summary scores include a total scale score and individual sub-scale scores. Higher scores on reversed scored items indicates better quality of life.The scores when reversed range from 0 to 100.Since there were an unequal number of items on the younger children's inventory, to be enrolled we used a cut-off of > or = 1.5 item mean on the PedsQL Inventory, which indicated poorer quality of life.

Children's Sleep Habits Questionnaire (CSHQ) (Owens, Spirito, & Mcguinn, 2000). The abbreviated CSHQ is a valid measure of sleep problems with good psychometric properties. It includes 33 items and is rated retrospectively over the previous week by parents to screen for the most common sleep problems. The Abbreviated CSHQ 33 items include eight key sleep domains. The eight subscales include: (1) bedtime resistance (2) sleep onset latency, (3) sleep duration, (4) anxiety around sleep, (5) night awakenings, (6) sleep disordered breathing, (7) parasomnias and (8) morning waking/daytime sleepiness. The 33 items are summed to get a total sleep disturbance score. A total sleep disturbance score of 41 or greater for the CSHQ's 33 items has been reported to be an appropriate clinical cut-off for identifying sleep disturbance in children. Responses range from 0 to 3 with a total range of 0 to 99 for all 33 items and higher scores indicate more sleep disturbance.

The PRAS-ASD (Scahill et al., 2019), is a parent-rated scale used to measure anxiety in children with autism spectrum disorder. The 25 items on the PRAS-ASD each range from 0 to 3 with a possible total of 75. Higher scores indication more anxiety.

Developmental Disabilities - Children's Global Assessment Scale (DD-CGAS) (Wagner et al., 2007). The clinician-rated DD-CGAS measures global functioning in children with developmental disorders in treatment studies. The DD-CGAS was used to characterize impairment in the following four domains: Self Care, Communication, Social Behavior, and School/Academic. In addition, this scale also includes a series of descriptive "bands" to characterize global functioning in children with pervasive developmental disorders from "extreme and pervasive impairment" through "superior functioning." Scores range fro 1 to 100 and higher scores on the DD-CGAS indicate increased independence of daily functioning.

Adverse Events (AEs). To minimize the risk, subjects will be systematically monitored. AEs, vital signs, including resting BP, will be evaluated at each visit throughout all phases of the study. When the treating clinician elicits an AE, it will be documented on a case report form, regardless of suspected relationship to the essential oil. For all AEs, the investigator will obtain sufficient information to determine the onset, course, and outcome of the AE. If a subject has experienced an AE, the subject may return to the site for an unscheduled visit at the PI's discretion. If any of these AEs are serious and/or unexpected, the site PI will contact the Sponsor and notify the IRB as appropriate.

Potential AEs include sun sensitivity due to the Bergamot in the essential oil, possibly gynecomastia in pre-pubescent males due to the lavender oil in the essential oil, and skin irritation at the application site.