Essential Oils for Enhancing QOL in ASD

NCT ID: NCT02543203

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-03-16

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.

Conditions

Autism Spectrum Disorder; Quality of Life; Sleep; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

A/C - Reconnect, Then Coconut Oil Comparator

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.

Group Type: ACTIVE_COMPARATOR

Reconnect

Intervention Type: BIOLOGICAL

Topical Essential Oils mixture and aromatic method

Coconut oil Comparator

Intervention Type: BIOLOGICAL

Topical Essential Oils mixture and aromatic method

C/A - Coconut oil Blend, Then Reconnect

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.

Group Type: SHAM_COMPARATOR

Reconnect

Intervention Type: BIOLOGICAL

Topical Essential Oils mixture and aromatic method

Coconut oil Comparator

Intervention Type: BIOLOGICAL

Topical Essential Oils mixture and aromatic method

Interventions

Reconnect

Topical Essential Oils mixture and aromatic method

Intervention Type: BIOLOGICAL

Coconut oil Comparator

Topical Essential Oils mixture and aromatic method

Intervention Type: BIOLOGICAL

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).

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Young Living Essential Oils

UNKNOWN

Sponsor Role: collaborator

Jill Hollway

OTHER

Sponsor Role: lead

Responsible Party

Jill Hollway

Research Scientist and Assistant Professor, Research Psychiatry

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jill A Hollway, Ph.D., M.A.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University, Nisonger Center UCEDD

Eugene Arnold, M.D.,M.A.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University, Nisonger Center UCEDD

Locations

Ohio State University Nisonger Center

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015H0005

Identifier Type: -

Identifier Source: org_study_id