Columbus, Ohio 43210


Purpose:

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. Approximately 34 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.


Study summary:

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 34 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. Thus, participants could receive one of two possible treatment courses: The length of participation in the study is 7 months, with two 3-month treatment phases and one 1-month washout period between the treatment phases. 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.


Criteria:

Inclusion Criteria: - Outpatients between 3 and 9 years of age, inclusive; - Diagnosis of Autism Spectrum Disorder (ASD) by DSM-V; - Total 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).


NCT ID:

NCT02543203


Primary Contact:

Principal Investigator
Jill A Hollway, Ph.D., M.A.
Ohio State University, Nisonger Center UCEDD

Taylor C Wong, BS
Phone: 614-685-3219
Email: Taylor.Wong@osumc.edu


Backup Contact:

Email: Jill.Hollway@osumc.edu
Jill A Hollway, Ph.D., M.A.
Phone: 614-688-3848


Location Contact:

Columbus, Ohio 43210
United States

Taylor C Wong, BS
Phone: 614-685-3219
Email: Taylor.Wong@osumc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.