Essential Oils for Enhancing of Quality of Life in Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Pediatric Quality of Life Inventory
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Pediatric Quality of Life Inventory
时间窗: 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.
次要结局
- Children's Sleep Habits Questionnaire(28 Weeks)
- Parent-rated Anxiety Scale for Autism Spectrum Disorder PRAS-ASD(28 Weeks)
研究者
Jill Hollway
Research Scientist and Assistant Professor, Research Psychiatry
Ohio State University