Essential Oils for Enhancing QOL in ASD

Study Overview
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Brief Summary
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Essential oils (aromatic oils extracted from plant parts) are routinely used by the public and are available on the market. Investigators are conducting this study because it is unknown whether the essential oils formulations will be safe and effective for improving quality of life in children with Autism Spectrum Disorder (ASD) by helping them relax and sleep. Children invited to participate in this study must be between 3-9 years of age and have been diagnosed with Autism Spectrum Disorder. Twenty eight children and their families will be enrolled in the study. Participants will try two different fragrant oils in a double-blind randomized order. Each child will receive each treatment for 3 months, with a 1-month washout period in between during which no oil is used.

Detailed Description
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The purpose of the study is to evaluate the use of two fragrant oil formulations to enhance quality of life by increasing relaxation and sleep quality in children with Autism Spectrum Disorder (ASD). Essential oils (aromatic oils extracted from plant parts) are routinely used by the public and are available on the market. Investigators are conducting this study because it is unknown whether the essential oils formulations will be safe and effective for helping children with ASD relax and sleep. To participate in this study children must be between 3-9 years of age and have been diagnosed with Autism Spectrum Disorder. Approximately 40 children will be screened to enroll 28 children and their families in the study. In a double-blind crossover study, participants will be randomized to treatment order. All participants will receive both fragrant oil blends. Those randomized will receive one fragrant oil blend for 3 months, with a 1-month washout period in between and then start the second fragrant oil blend in the last 3 months. The treatment orders are A/C and C/A. Study participation will last for 7 months. There will be one screening visit (about 5 hours long, which can be split into 2 visits), two baseline visits (about 2 hours each), two endpoint visits (2 hours each) and 5 other clinic visits (each 45-60 minutes). Visits will take place at the OSU Nisonger Center and the OSU General Clinical Research Center.

Official Title
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Essential Oils for Enhancing of Quality of Life in Autism Spectrum Disorder (ASD)

Conditions
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Sleep, Autism Spectrum Disorder, Quality of Life, Anxiety

Intervention / Treatment
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* Biological: Reconnect
* Biological: Coconut oil Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients between 3 and 9 years of age, inclusive; Diagnosis of Autism Spectrum Disorder (ASD) by DSM-V; Mean item score of > or = 1.5 PedsQL Inventory; Care provider who can reliably bring subject to clinic visits and provide trustworthy ratings. Exclusion Criteria: Bipolar disorder by Child & Adolescent Symptom Inventory (CASI, Gadow & Sprafkin, 1997) and clinical interview/history, or major depression accompanied by family history of bipolar disorder; Children with allergies to essential oils; Children with seizure disorder/epilepsy; Significant physical illness (e.g., serious cardiovascular, liver or renal pathology); Medications specifically given for insomnia and exogenous melatonin, which have the potential to confound study results, within the previous 2 weeks before baseline; Anticipated changes of doses of medication or other medical treatments or supplements; Weight less than 10 kg; Sleep Disordered Breathing (SDB) as defined by a total score of > or = 3 on the CSHQ SDB subscale and parent report; Nut allergies; Allergy to vanilla; A substantial trial of essential oil use within the past 6 months (i.e., consistent use for 6 weeks).

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A/C - Reconnect, Then Coconut Oil Comparator<br>Participants randomized to treatment order A/C, received Reconnect for 3-months each day, morning and evening. After a washout period of one-month, they received the Coconut Oil Comparator morning and evening for 3-months. AM: Children received a topical application of one drop of oil to the back of the neck and 1 drop to the feet. PM: Children received the oil blend by the aromatic method as it was diffused throughout their bedrooms while they slept. Each bottle has an orifice that allows the oil to be expelled drop by drop the evening dose was 8-12 drops added to the diffuser. | Biological: Reconnect<br>* Topical Essential Oils mixture and aromatic method<br>Biological: Coconut oil Comparator<br>* Topical Essential Oils mixture and aromatic method<br>|
| Sham Comparator: C/A - Coconut oil Blend, Then Reconnect<br>Participants randomized to treatment order C/A received the Coconut Oil Comparator for 3-months each day, morning and evening. After a washout period of one-month, they received Reconnect morning and evening for 3-months. AM: Children received a topical application of one drop of oil to the back of the neck and 1 drop to the feet. PM: Children received the oil blend by the aromatic method as it was diffused throughout their bedrooms while they slept. Each bottle has an orifice that allows the oil to be expelled drop by drop the evening dose was 8-12 drops added to the diffuser. | Biological: Reconnect<br>* Topical Essential Oils mixture and aromatic method<br>Biological: Coconut oil Comparator<br>* Topical Essential Oils mixture and aromatic method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Quality of Life Inventory | 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. | 28 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Sleep Habits Questionnaire | 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. | 28 Weeks | 
| Parent-rated Anxiety Scale for Autism Spectrum Disorder PRAS-ASD | 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. | 28 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relaxation