Autism Spectrum DisorderPhase 2NCT02543203
Essential Oils for Enhancing QOL in ASD
A Phase 2 study testing Reconnect and Coconut oil Comparator in people with Autism Spectrum Disorder and Quality of Life, run by Jill Hollway at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Quality of Life, Sleep
- What is being tested?
- Reconnect and Coconut oil Comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 16 Mar 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Nisonger Center
Columbus, Ohio, 43210
About this study
Official title: Essential Oils for Enhancing of Quality of Life in 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 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.
Read the 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
- Being tested
- Reconnect, Coconut oil Comparator
- Keywords
- Relaxation
- Medical subject headings
- Autism Spectrum Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReconnectBiological
Topical Essential Oils mixture and aromatic method
Coconut oil ComparatorBiological
Topical Essential Oils mixture and aromatic method
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Reconnect; Biological: Coconut oil Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 Weeks
Secondary outcomes (2)
Children's Sleep Habits Questionnaire
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.
Measured: 28 Weeks
Parent-rated Anxiety Scale for Autism Spectrum Disorder PRAS-ASD
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.
Measured: 28 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJul 2015
- Primary completion16 Mar 2018
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jill Hollway
- Sponsor type
- University, hospital or other
- Collaborators
- Young Living Essential Oils
- Responsible party
- Sponsor-investigator, Jill Hollway, Ohio State University
- Investigators
- Jill A Hollway, Ph.D., M.A., Principal investigator, Ohio State University, Nisonger Center UCEDDEugene Arnold, M.D.,M.A., Principal investigator, Ohio State University, Nisonger Center UCEDD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543203
- Sponsor's protocol ID
- 2015H0005
- Status last verified
- Mar 2021
- First submitted
- 17 Aug 2015
- Last updated
- 1 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: We will upload de-identified raw data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Oils for Enhancing of Quality of Life in Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT02543203
- Acronym / sponsor ID
- 2015H0005
- Conditions
- Autism Spectrum Disorder, Quality of Life, Sleep, Anxiety
- Keywords
- Relaxation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jill HollwayUniversity, hospital or other
- Collaborators
- Young Living Essential Oils
- Study start
- Jul 2015 (actual)
- Primary completion
- 16 Mar 2018 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 1 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A/C - Reconnect, Then Coconut Oil Comparator | Active comparator | Biological: Reconnect, Biological: Coconut oil ComparatorParticipants 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. |
| C/A - Coconut oil Blend, Then Reconnect | Sham comparator | Biological: Reconnect, Biological: Coconut oil ComparatorParticipants 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. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReconnectTopical Essential Oils mixture and aromatic method | Biological | A/C - Reconnect, Then Coconut Oil Comparator, C/A - Coconut oil Blend, Then Reconnect |
| Coconut oil ComparatorTopical Essential Oils mixture and aromatic method | Biological | A/C - Reconnect, Then Coconut Oil Comparator, C/A - Coconut oil Blend, Then Reconnect |
Primary outcome
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.
2 secondary outcomes
Children's Sleep Habits Questionnaire
Time frame: 28 Weeks
Parent-rated Anxiety Scale for Autism Spectrum Disorder PRAS-ASD
Time frame: 28 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will upload de-identified raw data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill A Hollway, Ph.D., M.A. principal investigator
Ohio State University, Nisonger Center UCEDD
Eugene Arnold, M.D.,M.A. principal investigator
Ohio State University, Nisonger Center UCEDD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reconnect and Coconut oil Comparator in people with Autism Spectrum Disorder and Quality of Life, run by Jill Hollway at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Quality of Life Inventory (time frame: 28 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.