A Complementary and Integrative Healthcare (CIH) Model for Children With Autism Spectrum Disorder-Related Symptoms: A Pilot Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Proportion of enrollees who are eligible to participate
研究概览
简要总结
To investigate the feasibility of implementing an online assessment battery in tandem with normal & customary complementary & integrative healthcare (CIH) provided to children with autism. The secondary aim is to assess the potential impacts of CIH on clinical outcomes.
详细描述
The main aim of this pilot observational study is to investigate the feasibility of implementing an online assessment battery in tandem with normal & customary, fee-for-service, remotely delivered complementary & integrative healthcare (CIH, i.e., naturopathy + functional neurological rehabilitation) provided to children with significant parent-reported autism spectrum disorder (ASD)-related symptoms. The primary outcomes are 1) eligibility, 2) compliance, 3) adherence, and 4) retention. A secondary/exploratory aim is to assess the potential clinical impacts of CIH via a validated parent-reported outcome measure (i.e., Autism Treatment & Evaluation Checklist; ATEC). Data from this study will inform the feasibility of a definitive study powered to assess the effectiveness of CIH care on clinical outcomes in a pediatric population with ASD-related symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3-12 years of age
- •Baseline ATEC score >71
排除标准
- •- History of epilepsy
研究组 & 干预措施
Children (3-12) with ASD-Related Symptoms
Children aged 3-12 years whose parents/caregivers identify the presence of symptoms associated with autism spectrum disorder (ASD; e.g., challenges in communication, social interaction, or repetitive behaviors). A formal clinical diagnosis is not required for inclusion
结局指标
主要结局
Proportion of enrollees who are eligible to participate
时间窗: From enrollment to baseline ATEC submission (up to 48-hours).
The number of enrollees (i.e., participants who consent) who score \>71 on the baseline Autism Treatment \& Evaluation Checklist (ATEC), divided by the total number of enrollees. This assesses 'Eligibility'.
Proportion of participants complying with instructions
时间窗: From enrollment to the end of participation (up to 6-months)
The number of participants submitting all online ATECs within the 48-hour submission window, divided by the total number of participants. This assesses 'Compliance'.
Proportion of participants adhering to recommendations
时间窗: From enrollment to the end of participation (up to 6-months)
The number of participants attending ≥90% of scheduled online check-ins with the CIH practitioners, divided by the total number of participants. This assesses 'Adherence'.
Proportion of participants retained in the study
时间窗: From enrollment to the end of the 6-month study period
The number of participants submitting the 5th and final ATEC, divided by the total number of participants. This assesses 'Retention'.
次要结局
- Change in ATEC scores(Baseline; ~1 month; ~3 months; ~4 months; ~6 months)
研究者
Tyson Perez, DC, PhD
PI
Life University