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临床试验/CTRI/2024/07/070980
CTRI/2024/07/070980尚未招募2/3 期

Assessing the efficacy of individualized homeopathic intervention in alleviating sleep dysregulation in children with Autism Spectrum Disorder: An experimental study utilizing CSHQ (Childrens Sleep Habits Questionnaire)

DrShraddha Shendre1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Efficacy of individualized homeopathic intervention in alleviating sleep dysregulation in children diagnosed with Autism Spectrum Disorder (ASD).

研究概览

简要总结

Title: Assessing the Efficacy of Individualized Homeopathic Intervention in Alleviating Sleep Dysregulation in Children with Autism Spectrum Disorder: An Experimental Study Utilizing CSHQ (Children’s Sleep Habits Questionnaire)

Introduction: Sleep dysregulation is a prevalent issue among children with autism spectrum disorder (ASD), affecting up to 80% of this population. These disturbances significantly impact the child’s well-being and family dynamics. Traditional medical treatments have limitations, prompting exploration of alternative therapies such as individualized homeopathic interventions.

Primary Objective: To determine the effectiveness of individualized homeopathic intervention in alleviating sleep dysregulation in children with ASD, as measured by the Children’s Sleep Habits Questionnaire (CSHQ).

Secondary Objectives:

  1. To compare changes in sleep patterns and parameters (e.g., sleep onset latency, sleep duration, night awakenings) between the experimental group receiving homeopathic intervention and the control group not receiving the intervention.

  2. To evaluate the association between the improvement of sleep dysregulation and the reduction in ASD symptoms.

Methodology:

  • Study Type: Experimental Study

  • Study Design: Randomized Controlled Trial (RCT), Double Blinded

  • Participants: 50 children aged 3-15 years with ASD and sleep dysregulation, divided into an experimental group (30 participants) and a control group (20 participants).

  • Intervention: The experimental group will receive individualized homeopathic treatment, while the control group will receive a placebo. Both groups will also receive psychotherapy.

  • Duration: The intervention period will last for 3 months.

  • Measurements: Sleep patterns will be assessed using the CSHQ at baseline and post-intervention. ASD symptoms will be evaluated using standardized diagnostic criteria.

Expected Outcomes: The study aims to provide evidence on the efficacy of homeopathic interventions in improving sleep and reducing ASD symptoms, offering a potential non-pharmacological treatment option.

Ethical Considerations: The study will adhere to ethical guidelines, ensuring informed consent, privacy, and confidentiality of participants. Ethical approval will be obtained from relevant institutional review boards.

Conclusion: This study seeks to enhance understanding of homeopathic interventions as a viable treatment for sleep dysregulation in children with ASD, potentially improving their overall quality of life and that of their families.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
3.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed case of Autism Spectrum Disorder as confirmed by a qualified professional.
  • Sleep dysregulation, including difficulties with sleep onset, night awakenings, or overall poor sleep quality.
  • Age between 3 and 15 years.

排除标准

  • 1.Have significant medical conditions, gross pathological comorbidity, or sleep disorders unrelated to their ASD diagnosis (e.g. Obstructive sleep apnoea, chronic kidney or lung disease, obesity, Diabetes, Hypothyroidism, hereditary tendency of sleep dysregulation etc.) 2.Are currently receiving any other alternative or complementary treatments for ASD or sleep difficulties (e.g.- Melatonin.

结局指标

主要结局

Efficacy of individualized homeopathic intervention in alleviating sleep dysregulation in children diagnosed with Autism Spectrum Disorder (ASD).

时间窗: Post intervention assessment after 3 months through CSHQ

次要结局

  • Changes in sleep pattern and parameters(Measured at baseline and at end of the 3 months intervention period through CSHQ)
  • Improvement in Symptoms of ASD(Measured at baseline and at end of the 3 month intervention period through Autism Treatment Evaluation Checklist)

研究者

发起方
DrShraddha Shendre
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shraddha Shendre

Smt Malini Kishore Sanghvi Homoeopathic Medical College & Hospital

研究点 (1)

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