Essential Oils for Enhancing QOL in ASD

NCT02543203 | Completed Phase 2 Results

• 1 other identifier: 2015H0005
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Quality of Life; Sleep; Anxiety

Keywords

Relaxation

Outcome Measures

Primary Outcomes (1)

• Pediatric Quality of Life Inventory

  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.

  28 Weeks

Secondary Outcomes (2)

• Children's Sleep Habits Questionnaire

  28 Weeks

• Parent-rated Anxiety Scale for Autism Spectrum Disorder PRAS-ASD

  28 Weeks

Other Outcomes (2)

• Developmental Disabilities - Children's Global Assessment Scale (DD=CGAS)

  28 Weeks

• Adverse Events

  28 Weeks

Study Arms (2)

A/C - Reconnect, Then Coconut Oil Comparator

ACTIVE 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; Biological: Coconut oil Comparator

C/A - Coconut oil Blend, Then Reconnect

SHAM COMPARATOR

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; Biological: Coconut oil Comparator

Interventions

Reconnect BIOLOGICAL

Topical Essential Oils mixture and aromatic method

A/C - Reconnect, Then Coconut Oil Comparator; C/A - Coconut oil Blend, Then Reconnect

Coconut oil Comparator BIOLOGICAL

Topical Essential Oils mixture and aromatic method

A/C - Reconnect, Then Coconut Oil Comparator; C/A - Coconut oil Blend, Then Reconnect

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jill Hollway: lead
• Young Living Essential Oils: collaborator

Study Sites (1)

Ohio State University Nisonger Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Jill Ann Hollway
• Organization: The Ohio State University Nisonger Center

Jill.Hollway@osumc.edu

614-688-3848

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Scientist and Assistant Professor, Research Psychiatry

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: September 7, 2015
• Study Start: July 1, 2015
• Primary Completion: March 16, 2018
• Study Completion: March 16, 2018
• Last Updated: April 1, 2021
• Results First Posted: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 12/30/2019
• Access Criteria: Raw data in PDF archive and study report

Locations

US (1)