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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
Last Update Posted : October 3, 2018
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. Approximately 34 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 Biological: Essential Oil Mixture A Biological: Essential Oils Mixture B 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 34 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. Thus, participants could receive one of two possible treatment courses:

The length of participation in the study is 7 months, with two 3-month treatment phases and one 1-month washout period between the treatment phases. 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 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: Essential Oil Mixture A

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.

Biological: Essential Oil Mixture A
Topical Essential Oils mixture and aromatic method

Biological: Essential Oils Mixture B
Topical Essential Oils mixture and aromatic method

Active Comparator: Essential Oil Mixture B

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.

Biological: Essential Oil Mixture A
Topical Essential Oils mixture and aromatic method

Biological: Essential Oils Mixture B
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 23-item PedsQL Generic Core Scales 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 Multidimensional Scales are: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. The summary scores include a Total Scale Score, a Physical Health Summary Score, and a Psychosocial Health Summary Score. Investigators will use the age-normed scale for each child that matches the age the child is expected to be at the end of the first condition; once selected, the same scale will be used throughout that child's participation. To be enrolled participants will have clinically significant problems with quality of life (i.e., total item mean score of > or = 1.5).


Secondary Outcome Measures :
  1. Parent Stress Index [ Time Frame: 28 Weeks ]
    Parent Stress Index (PSI) (Abidin, 1995). The PSI is used to evaluate the degree of stress in the parent-child relationship. The Short Form is composed of 36 items taken from the full length PSI and is completed in 10-15 minutes. Child characteristics in the full scale include Distractibility/Hyperactivity, Adaptability, Reinforces Parent, Demandingness, Mood, and Acceptability. Parent measures include Competence, Isolation, Attachment, Health, Role Restriction, Depression, and Spouse. The PSI is used for early identification of dysfunctional parent-child interactions, parental stress, and family functioning. It may be used for parents of children up to 12 years, but it is primarily intended for parents of children 0-3 years. The 90th percentile of the Total PSI score represents a clinically significant level of parenting stress (i.e., total score of > 260).

  2. 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 CSHQ incorporates items related to 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. A Total Score of 41 or greater on the CSHQ 33 items has been reported to be an appropriate clinical cut-off for identifying sleep problems in children.

  3. The Autism Anxiety Scale [ Time Frame: 28 Weeks ]
    The Autism Anxiety Scale (AAS)(Aman, Scahill, Lecavalier, and Sukodolsky, 2013). Investigators from OSU, Emory University, and Children's Hospital of Philadelphia (CHOP) are engaged in developing what will be the definitive instrument for measuring anxiety in children with autism spectrum disorders (NIMH grant "Toward outcome measurement of anxiety in youth with autism spectrum disorders"). This project uses the Children and Adolescent Symptom Inventory's (CASI) anxiety items as its nucleus.This scale will likely become the standard for use in randomized clinical trials. Investigators will use an early version of this cutting-edge scale.


Other Outcome Measures:
  1. Aberrant Behavior Checklist [ Time Frame: 28 Weeks ]
    Aberrant Behavior Checklist (ABC).The ABC is a 58-item parent-report measure with five subscales: 1) Irritability (includes agitation, aggression and self-injurious behaviors, 15 items); 2) Social Withdrawal (16 items); 3) Stereotypies (7 items); 4) Hyperactivity (16 items); and 5) Inappropriate Speech (4 items), (Aman et al., 1985a; Aman et al. 1985b; Aman et al., 1987, Brown, Aman, & Havercamp, 2002). Psychometric characteristics of the ABC range from satisfactory to very good (Aman et al.,1985b). The ABC has been commonly used in research on children with ASD and is highly sensitive. Its parent-rated five subscales will be used to explore whether the use of Essential Oils is associated with behavior changes during the day. Investigators will evaluate the ABC to assess irritability levels and improvement over the course of the study. The ABC will be an exploratory outcome measure.

  2. Developmental Disabilities - Children's Global Assessment Scale [ Time Frame: 28 Weeks ]
    Developmental Disabilities - Children's Global Assessment Scale (DD-CGAS) (Wagner et al., 2007). The DD-CGAS is a reliable instrument for measuring global functioning of children with developmental disorders in treatment studies. Investigators will use the DD-CGAS to characterize children's impairment on 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."

  3. Social Responsiveness Scale [ Time Frame: 28 Weeks ]
    Social Responsiveness Scale (SRS) (Costantino et al., 2003). This 65-item rating scale measures the severity of autism spectrum symptoms as they occur in natural social settings. Completed by a parent or teacher in 15 to 20 minutes, the SRS provides a clear picture of a child's social impairments, assessing social awareness, social information processing, capacity for reciprocal social communication, social anxiety/avoidance, and autistic preoccupations and traits. It is appropriate for use with children from 4 to 18 years of age. Sensitive and reliable across a wide range of symptom severity, the SRS can be used as a screener in clinical or educational settings, an aid to clinical diagnosis, or a measure of response to intervention. SRS scores are particularly helpful in identifying Autism, Asperger's Disorder, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS), and Schizoid Personality Disorder of Childhood.

  4. Short Sensory Profile [ Time Frame: 28 Weeks ]
    Short Sensory Profile (SP) (Dunn, 1999). The Short Sensory Profile is a 38-item caregiver questionnaire and score sheet designed for use in screening and research protocols. The items on the Short Sensory Profile are grouped into three major sections: sensory processing, modulation, and behavioral and emotional responses. In a recent report it was found that sensory sensitivities were related to sleep difficulties in children with ASD (Hollway, Aman, Butter, 2013). Investigators will use the SP to track sensory sensitivities which may be related to avoidance behavior that interferes with family QOL, over the course of the study. The SP will be an exploratory measure.

  5. 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.


  6. Sleep Quality [ Time Frame: 28 Weeks ]

    Approximately 50% of participants will wear a Motionlogger Micro Watch, a device known as an actigraph that measures sleep quality. Participants will wear the devices for 5 consecutive nights, on 3 separate occasions. They will yield the following sleep variables: 1) time in bed, 2) total sleep time (from lights out), 3) sleep onset latency, 4) morning waking time, 5) frequency of night wakings, 6) longest sleep period, and 7) sleep efficiency. This is a reliable method of objective data collection for sleep-wake patterns including timing, continuity, and duration of sleep.

    A parent/caregiver diary documenting overall information about participant sleep-wake behavior patterns will be also implemented. These data will be evaluated for their reliability when compared to the Motionlogger Micro Watch.


  7. Repetitive Behavior Scale - Revised [ Time Frame: 28 Weeks ]
    Repetitive Behavior Scale - Revised (RBS-R). The RBS-R is a 43-item self-report questionnaire used to measure the breadth of repetitive behavior in children, adolescents, and adults with Autism Spectrum Disorders. The RBS-R provides a quantitative, continuous measure of the full spectrum of repetitive behaviors. The RBS-R consists of six subscales including: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted Behavior that have no overlap of item content. This permits differential identification and scoring of discrete varieties of repetitive behaviors. Behaviors are rated on a 4-point scale: 0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem. Investigators will use the RBS-R to assess repetitive behaviors and improvement over the course of the study.



Information from the National Library of Medicine

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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;
  • Total 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
United States, Ohio
Ohio State University Nisonger Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Jill Hollway
Young Living Essential Oils
Investigators
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

Responsible Party: Jill Hollway, Research Scientist and Assistant Professor, Research Psychiatry, Ohio State University
ClinicalTrials.gov Identifier: NCT02543203     History of Changes
Other Study ID Numbers: 2015H0005
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

Keywords provided by Jill Hollway, Ohio State University:
Relaxation

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders