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Essential Oils for Enhancing QOL in ASD

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ClinicalTrials.gov Identifier: NCT02543203
Recruitment Status : Completed
First Posted : September 7, 2015
Results First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
Young Living Essential Oils
Information provided by (Responsible Party):
Jill Hollway, Ohio State University

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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Quality of Life Sleep Anxiety Biological: Reconnect Biological: Coconut oil Comparator Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Essential Oils for Enhancing of Quality of Life in Autism Spectrum Disorder (ASD)
Actual Study Start Date : July 2015
Actual Primary Completion Date : March 16, 2018
Actual Study Completion Date : March 16, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

Biological: Reconnect
Topical Essential Oils mixture and aromatic method

Biological: Coconut oil Comparator
Topical Essential Oils mixture and aromatic method

Sham Comparator: 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.

Biological: Reconnect
Topical Essential Oils mixture and aromatic method

Biological: Coconut oil Comparator
Topical Essential Oils mixture and aromatic method




Primary Outcome Measures :
  1. Pediatric Quality of Life Inventory [ Time Frame: 28 Weeks ]
    Pediatric Quality of Life Inventory (PedsQL) (Varni, Burwinkle, & Seid, 2006). The Generic PedsQL Inventory is a caregiver-rated scale for children ages 2-12. The PedsQL Inventory for 2-4 year old children includes 21 items. The PedsQL Inventories for 5-12 year old children include 23-items. The PedsQL Inventories were designed to measure the core domains of health and their impact on the quality of life in children as outlined by the World Health Organization. The four sub-scales are Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. The summary scores include a total scale score and individual sub-scale scores. Higher scores on reversed scored items indicates better quality of life.The scores when reversed range from 0 to 100.Since there were an unequal number of items on the younger children's inventory, to be enrolled we used a cut-off of > or = 1.5 item mean on the PedsQL Inventory, which indicated poorer quality of life.


Secondary Outcome Measures :
  1. Children's Sleep Habits Questionnaire [ Time Frame: 28 Weeks ]
    Children's Sleep Habits Questionnaire (CSHQ) (Owens, Spirito, & Mcguinn, 2000). The abbreviated CSHQ is a valid measure of sleep problems with good psychometric properties. It includes 33 items and is rated retrospectively over the previous week by parents to screen for the most common sleep problems. The Abbreviated CSHQ 33 items include eight key sleep domains. The eight subscales include: (1) bedtime resistance (2) sleep onset latency, (3) sleep duration, (4) anxiety around sleep, (5) night awakenings, (6) sleep disordered breathing, (7) parasomnias and (8) morning waking/daytime sleepiness. The 33 items are summed to get a total sleep disturbance score. A total sleep disturbance score of 41 or greater for the CSHQ's 33 items has been reported to be an appropriate clinical cut-off for identifying sleep disturbance in children. Responses range from 0 to 3 with a total range of 0 to 99 for all 33 items and higher scores indicate more sleep disturbance.

  2. Parent-rated Anxiety Scale for Autism Spectrum Disorder PRAS-ASD [ Time Frame: 28 Weeks ]
    The PRAS-ASD (Scahill et al., 2019), is a parent-rated scale used to measure anxiety in children with autism spectrum disorder. The 25 items on the PRAS-ASD each range from 0 to 3 with a possible total of 75. Higher scores indication more anxiety.


Other Outcome Measures:
  1. Developmental Disabilities - Children's Global Assessment Scale (DD=CGAS) [ Time Frame: 28 Weeks ]
    Developmental Disabilities - Children's Global Assessment Scale (DD-CGAS) (Wagner et al., 2007). The clinician-rated DD-CGAS measures global functioning in children with developmental disorders in treatment studies. The DD-CGAS was used to characterize impairment in the following four domains: Self Care, Communication, Social Behavior, and School/Academic. In addition, this scale also includes a series of descriptive "bands" to characterize global functioning in children with pervasive developmental disorders from "extreme and pervasive impairment" through "superior functioning." Scores range fro 1 to 100 and higher scores on the DD-CGAS indicate increased independence of daily functioning.

  2. Adverse Events [ Time Frame: 28 Weeks ]

    Adverse Events (AEs). To minimize the risk, subjects will be systematically monitored. AEs, vital signs, including resting BP, will be evaluated at each visit throughout all phases of the study. When the treating clinician elicits an AE, it will be documented on a case report form, regardless of suspected relationship to the essential oil. For all AEs, the investigator will obtain sufficient information to determine the onset, course, and outcome of the AE. If a subject has experienced an AE, the subject may return to the site for an unscheduled visit at the PI's discretion. If any of these AEs are serious and/or unexpected, the site PI will contact the Sponsor and notify the IRB as appropriate.

    Potential AEs include sun sensitivity due to the Bergamot in the essential oil, possibly gynecomastia in pre-pubescent males due to the lavender oil in the essential oil, and skin irritation at the application site.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543203


Locations
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United States, Ohio
Ohio State University Nisonger Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Jill Hollway
Young Living Essential Oils
Investigators
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Principal Investigator: Jill A Hollway, Ph.D., M.A. Ohio State University, Nisonger Center UCEDD
Principal Investigator: Eugene Arnold, M.D.,M.A. Ohio State University, Nisonger Center UCEDD
  Study Documents (Full-Text)

Documents provided by Jill Hollway, Ohio State University:
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Responsible Party: Jill Hollway, Research Scientist and Assistant Professor, Research Psychiatry, Ohio State University
ClinicalTrials.gov Identifier: NCT02543203    
Other Study ID Numbers: 2015H0005
First Posted: September 7, 2015    Key Record Dates
Results First Posted: April 1, 2021
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will upload de-identified raw data.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 12/30/2019
Access Criteria: Raw data in PDF archive and study report
Keywords provided by Jill Hollway, Ohio State University:
Relaxation
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders