Clinical trial NCT02543203: Essential Oils for Enhancing QOL in ASD
Official title: Essential Oils for Enhancing of Quality of Life in Autism Spectrum Disorder (ASD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Quality of Life
Sleep
Anxiety
Keywords: Relaxation
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Young Living Essential Oils
First posted: 2015-09-07
Enrollment: 28
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

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).

Primary outcomes:
measure: Pediatric Quality of Life Inventory
timeFrame: 28 Weeks
Secondary outcomes:
measure: Children's Sleep Habits Questionnaire
timeFrame: 28 Weeks
measure: Parent-rated Anxiety Scale for Autism Spectrum Disorder PRAS-ASD
timeFrame: 28 Weeks
Other outcomes:
measure: Developmental Disabilities - Children's Global Assessment Scale (DD=CGAS)
timeFrame: 28 Weeks
measure: Adverse Events
timeFrame: 28 Weeks
Locations:
city: Columbus
country: United States
facility: Ohio State University Nisonger Center
state: Ohio
Study officials:
affiliation: Ohio State University, Nisonger Center UCEDD
name: Jill A Hollway, Ph.D., M.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University, Nisonger Center UCEDD
name: Eugene Arnold, M.D.,M.A.
role: PRINCIPAL_INVESTIGATOR
References: