FLIGHT - Autism: An Open-Label, Prospective Study Evaluating the Feasibility and Effectiveness of an Education and Health Coaching Program Focused on Modifiable Lifestyle Factors for Parents of Children With Newly Diagnosed Autism
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Autism Treatment Evaluation Checklist (ATEC)
研究概览
简要总结
The primary purpose of this study is to evaluate the feasibility and effectiveness of an education and coaching program for parents of children with newly diagnosed autism that is focused on modifiable lifestyle factors and environmental modifications. A single-arm, open-label, prospective study will be conducted evaluating the feasibility and effectiveness of the 12-month education and health coaching intervention for parents as an adjuvant to comprehensive clinical care for 12 newly diagnosed children with autism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child from 3-7 years of age
- •Child has autism diagnosis featuring evaluation with the Autism Diagnostic Observation Schedule, 2nd Edition [ADOS-2], Childhood Autism Rating Scale, Second Edition (CARS-2), or Autism Diagnostic Interview - Revised (ADI-R) within the last 18 months
- •Child has an Autism Treatment Evaluation Checklist (ATEC) score at screening of between 50 and 120 (generally considered moderate/severe autism)
- •Child and parents live in the United States
- •Parent has ability to speak and read English
- •Parents are willing to fulfill study expectations
- •Child has not yet engaged in comprehensive diet, lifestyle, and environmental interventions for autism
排除标准
- •Parents who are unwilling or unable to make lifestyle changes, such as significant dietary changes
- •Parents who are unwilling or unable to participate in study activities, such as group and individual coaching
- •Parents who hold beliefs that are incompatible with an education and lifestyle intervention
- •Child who requires significant specialty medical care, including routine or frequent in-patient medical treatment, are currently taking mood stabilizing drugs, and/or who have cancer or a pre-cancerous condition
- •Child who has been diagnosed with complex conditions in addition to autism, such as an inborn error of metabolism identified through genetic testing, or a known chromosomal disorder
- •Parents who are unable or unwilling to provide consent
研究组 & 干预措施
Parent education and coaching program for newly diagnosed autism
Education and coaching program for parents of children with newly diagnosed autism focused on modifiable lifestyle factors and environmental modifications
干预措施: Parent education and coaching program for newly diagnosed autism (Behavioral)
结局指标
主要结局
Autism Treatment Evaluation Checklist (ATEC)
时间窗: Assessed at baseline, six months, 12 months
The assessment consists of four subtests: Speech/Language Communication (14 items), Sociability (20 items), Sensory/Cognitive Awareness (18 items), and Health/Physical/Behavior (25 items). Each item is rated on a scale from 0 (no problem) to 3 (severe problem), with total scores ranging from 0 to 180. Lower scores indicate less autism symptom severity.
次要结局
- Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)(Assessed at baseline and 12 months)
- Behavior Assessment System for Children, Third Edition (BASC-3)(Assessed at baseline, 6 months, and 12 months)
- Short Sensory Profile 2(Assessed at baseline, 6 months, and 12 months)
- Children's Sleep Habits Questionnaire (CSHQ)(Assessed at baseline, 6 months, and 12 months)
- Goodenough Assessment of Child Drawing(Assessed at baseline, 6 months, and 12 months)
- Automated Self-Administered 24-hour Dietary Assessment Tool (ASA-24)(Assessed at baseline, 6 months, and 12 months.)