The Effect of Aroma on Anxiety Among Children With Autism.

Study Overview
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Brief Summary
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This study evaluates the effects of essential oils on anxiety scores among children who have an autism spectrum disorder. One third of the children will receive a control blend of oils, one third of the children will receive a test blend of oils, and the other third will receive a second test blend of oils.

Detailed Description
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Essential oils have been found in studies to reduce both stress and anxiety as measured by an anxiety inventory, but studies have not tested these effects among children who have an autism spectrum disorder. The essential oils used in this study are administered each morning for a total period of four weeks, with an optional second exposure on an as-needed basis during the final two of the four weeks of the study. The oils are administered during this time to evaluate both the preventive effects and the treatment effects of the essential oils. Anxiety is measured on an anxiety inventory, which is completed by the parent of the participant at the end of each week during the study. Parents complete this data online, allowing them to participate from anywhere in the U.S.

Official Title
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The Effect of Aroma on Anxiety Among Children With Autism.

Conditions
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Anxiety, Autism Spectrum Disorder

Intervention / Treatment
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* Other: Test Essential Oil Blend
* Other: Active Essential Oil Blend
* Other: Control Blend


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 6-11 years old at enrollment diagnosed with an autism spectrum disorder Exclusion Criteria: mast cell activation syndrome history of adverse response to essential oil inhalation

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Essential Oil Blend<br>Participants in this arm receive the test essential oil inhaler to administer during the 4-week intervention. | Other: Test Essential Oil Blend<br>* The test essential oil blend consists of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.<br>|
| Active Comparator: Active Essential Oil Blend<br>Participants in this arm receive an active essential oil inhaler to administer during the 4-week intervention. | Other: Active Essential Oil Blend<br>* The active essential oil blend consists of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.<br>|
| Placebo Comparator: Control<br>Participants in this arm receive a control inhaler to administer during the 4-week intervention. | Other: Control Blend<br>* The control blend consists of inert vegetable oils which are produced from plant matter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 39-Question Spence Children's Anxiety Scale (SCAS) | The Spence Children's Anxiety Scale collects parent-reported signs and symptoms of anxiety at baseline and again at the end of each week of the intervention. Each item is scored as (0) never, (1) sometimes (2) often, or (3)always. The total score ranges from 0-114, with higher scores indicating higher levels of anxiety. | baseline and day 35 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Essential Oils, Aromatherapy, Anxiety, Autism Spectrum Disorder