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| Name | Class |
|---|---|
| Young Living Essential Oils | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reconnect | Biological | Topical Essential Oils mixture and aromatic method |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Developmental Disabilities - Children's Global Assessment Scale (DD=CGAS) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Nisonger Center | Columbus | Ohio | 43210 | United States |
We will upload de-identified raw data.
12/30/2019
Raw data in PDF archive and study report
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Of the 40 subjects screened, 28 were randomized to treatment order. Twelve subjects did not meet the study criteria. After randomization, one subject's caregiver revealed that she could not stop melatonin treatment and another caregiver withdrew because there was a death in the family. The modified intent to treat sample included 26 participants.
Forty subjects were screened for eligibility between between July 22nd 2015 and June 22nd 2017, at the Ohio State University's Nisonger Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reconnect, Then Comparator | Participants received Reconnect each morning and evening for 3-months and then after a 1-month washout they received the comparator oil. In the morning the oil was administered topically. Participants were administered 1 drop to the back of the neck and 1 drop to the feet, to be rubbed in for 30 seconds to 1 minute. In the evening, before bedtime, the aromatic method was used. Caregivers diffused 8-12 drops of oil in water at night. |
| FG001 | Coconut Oil Comparator, Then Reconnect | Participants received the comparator oil each morning and evening for 3-months and then after a 1-month washout they received Reconnect. In the morning the oil was administered topically. Participants were administered 1 drop to the back of the neck and 1 drop to the feet, to be rubbed in for 30 seconds to 1 minute. In the evening, before bedtime, the aromatic method was used. Caregivers diffused 8-12 drops of oil in water at night. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Twenty eight subjects were randomized but 2 terminated after the Baseline visit and the data analyzed was an MITT sample of 26 participant who had data for at least one other study visit from Baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | A/C (Reconnect/Comparator) | Topical: Apply 1 drop to the back of the neck and 1 drop to the feet. Rub in the oil for 30 seconds to 1 minute. Each bottle has an orifice that allows the oil to be expelled drop by drop. Dilution is not required, except for the most sensitive skin. Apply in the morning. Aromatic Method: Diffuse one diffuser-full (8-12 drops of oil in water) at night. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Early terminations occurred throughout the study. Described in study flow table. | Posted | Mean | Standard Deviation | Total Score | 28 Weeks |
|
Participants are systematically monitored for adverse events by study physicians (at all 10 visits). Vital signs, including resting BP, were evaluated at every visit as well.
According to all laboratory reports and physician review of adverse events potentially related to oil blend administration, there are no clinically significant abnormal values or adverse events. Recorded adverse events related to study treatment include minor events such as hyperactivity and intolerance to oil smell
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reconnect | Subjects were randomized to treatment order in a cross-over study design. The adverse events noted below were recorded from subjects in the Reconnect group. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| URI | Respiratory, thoracic and mediastinal disorders | URI | Non-systematic Assessment | Upper respiratory infection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jill Ann Hollway | The Ohio State University Nisonger Center | 614-688-3848 | Jill.Hollway@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2016 | Apr 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Coconut oil Comparator | Biological | Topical Essential Oils mixture and aromatic method |
|
| 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. | 28 Weeks |
| 28 Weeks |
| Adverse Events | 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. | 28 Weeks |
| Increased Irritability |
|
| Family |
|
| Negative Behavior |
|
| Withdrawal by Subject |
|
| BG001 | C/A (Comparator/Reconnect) | Topical: Apply 1 drop to the back of the neck and 1 drop to the feet. Rub in the oil for 30 seconds to 1 minute. Each bottle has an orifice that allows the oil to be expelled drop by drop. Dilution is not required, except for the most sensitive skin. Apply in the morning. Aromatic Method: Diffuse one diffuser-full (8-12 drops of oil in water) at night. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Children's Sleep Habits Questionnaire (CSHQ) | Mean | Full Range | units on a scale 0 to 99 higher worse |
|
| Parent-rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD) | Mean | Full Range | units on a scale 0 to 75 higher worse |
|
| Title |
|---|
| Description |
|---|
| OG000 | Subjects Received Re-Connect Then the Comparator Oil Blend | Subjects were randomized to order. Twelve subjects were randomized to Re-connect for the first 3-months, then after the one-month washout they received the coconut oil comparator during the last 3-months. The PedsQL was administered at screen, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment) |
| OG001 | Subjects Revieved the Comparator Oil Blend and Then Re-Connnec | Subjects were randomized to treatment order. Fourteen subjects received the comparator oil blend for the first 3-months, then after the one-month washout they received Re-connect (last 3-months).The PedsQL was administered at screen, Visit 6 (at the end of the first treatment), and Visit 10 (the end of the second treatment) |
|
|
| Secondary | 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. | Early terminations occurred through out the study. See the Study flow table. | Posted | Mean | Standard Deviation | Sleep Disturbance Total Score of 33 item | 28 Weeks |
|
|
|
| Secondary | 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. | Early terminations occurred throughout the study. See the study flow table. | Posted | Mean | Standard Deviation | Total Score | 28 Weeks |
|
|
|
| Other Pre-specified | Developmental Disabilities - Children's Global Assessment Scale (DD=CGAS) | 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. | Early terminations occurred throughout the study. See the study flow table. | Posted | Mean | Standard Deviation | Clinician Global Rating | 28 Weeks |
|
|
|
| Other Pre-specified | Adverse Events | 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. | Posted | Number | total number of events per condition | 28 Weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 24 |
| 24 |
| EG001 | Coconut Oil Blend (Comparator) | Subjects were randomized to treatment order in a cross-over study design. The adverse events noted below were recorded from subjects in the coconut oil comparator group. | 0 | 23 | 0 | 23 | 23 | 23 |
|
| Increased Irritability | Psychiatric disorders | Irritability | Non-systematic Assessment | Increased Irritability |
|
| Streptococcal pharyngitis, | Infections and infestations | Streptococcal pharyn | Non-systematic Assessment | Streptococcal pharyngitis |
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| Vomiting | Gastrointestinal disorders | Vomiting | Non-systematic Assessment | Vomiting |
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| Enuresis | Renal and urinary disorders | Enuresis | Non-systematic Assessment | Enuresis |
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| Environmental Allergy | Immune system disorders | Allergy | Non-systematic Assessment | Allergy |
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| Tussis | Respiratory, thoracic and mediastinal disorders | Tussis | Non-systematic Assessment | Tussis or cough |
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| Fever | Infections and infestations | Fever | Non-systematic Assessment | Fever |
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| Gastroenteritis | Gastrointestinal disorders | Gastroenteritis | Non-systematic Assessment | Gastroenteritis |
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| Gastrointestinal upset | Gastrointestinal disorders | Gastrointestinal Ups | Non-systematic Assessment | Gastrointestinal upset |
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| Increased Self Injury | Psychiatric disorders | Increased Self injur | Non-systematic Assessment | Increased Self Injury (biting self) |
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| Otitis media | Ear and labyrinth disorders | Otitis media | Non-systematic Assessment | Otitis media |
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| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Rhinorrhea | Non-systematic Assessment | Rhinorrhea |
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| Sleep disturbance | Psychiatric disorders | Sleep disturbance | Non-systematic Assessment | Sleep disturbance |
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| Viral exanthem | Skin and subcutaneous tissue disorders | Viral exanthem | Non-systematic Assessment | Exanthem rash or eruption on the skin due to virus |
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| Increase of verbal stemming | Psychiatric disorders | Verbal stemming | Non-systematic Assessment | Increase in verbal stemming (squealing) |
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| Adverse reaction to noxious oil smell | Respiratory, thoracic and mediastinal disorders | Noxious oil smell | Non-systematic Assessment | Noxious oil smell |
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