Phase 2
Completed N=28
Essential Oils for Enhancing QOL in ASD
Source: ClinicalTrials.gov NCT02543203 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Pediatric Quality of Life Inventory — 45.5; 56.2; 61.5; 65.3 Total Score
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pediatric Quality of Life Inventory |
45.5; 56.2; 61.5; 65.3; 64.3; 66.6 | — |
| SECONDARY Children's Sleep Habits Questionnaire |
54.3; 49.7; 42.6; 43.1; 43.0; 44.5 | — |
| SECONDARY Parent-rated Anxiety Scale for Autism Spectrum Disorder PRAS-ASD |
32.6; 31.7; 12.6; 26.4; 7.9; 24.0 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02543203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.