A Telehealth-Delivered Physical Activity Intervention Improves Sleep and Reduces Parental Stress in Children With Autism Spectrum Disorder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Objective Wake After Sleep Onset
研究概览
简要总结
This study aims to test whether a physical activity program delivered through telehealth can help improve sleep quality in children with autism spectrum disorder (ASD) and reduce stress and improve well-being in their parents.
Children in the study will wear a small device (an accelerometer) to measure their physical activity levels and sleep. Parents will answer questionnaires about their child's sleep habits, behavior, and social skills, as well as their own sleep, stress levels, and parenting experience.
The program will be delivered remotely, allowing families to participate from their homes. It includes guided physical activities, family-based exercises, and regular telehealth support from professionals.
The goal is to find out if this type of remote support can help both children with autism and their caregivers in daily life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is a child aged 8 to 12 years with a confirmed diagnosis of Autism Spectrum Disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- •A parent or primary caregiver aged 18 years or older is willing and able to participate in the study.
- •The child demonstrates the ability to understand and follow simple instructions necessary for study procedures.
- •Presence of significant parent-reported insomnia symptoms, specifically defined as bedtime resistance, sleep-onset delay, or night awakenings occurring on five to seven nights per week, as identified using the Children's Sleep Habits Questionnaire (CSHQ).
排除标准
- •The participant is currently receiving, or has recently completed, pharmacological or formal behavioral treatment for sleep problems.
- •Presence of any medical condition that significantly limits physical activity (e.g., moderate-to-severe asthma, congenital heart disease).
- •Diagnosis of a complex neurological disorder (e.g., epilepsy).
- •Presence of other known medical or psychiatric conditions that could be the primary cause of sleep disturbance (e.g., sleep apnea, restless legs syndrome, severe anxiety).
研究组 & 干预措施
In-Person Physical Activity (In-PA) Program
Participants in this arm are assigned to a 16-week, structured, in-person physical activity regimen. Children attend three 40-minute sessions per week on-site at a partner school. Sessions are delivered by certified physical education instructors trained in a standardized protocol. The curriculum incorporates five core components: an Individualized Motor Protocol, Structured Group Sessions, Self-Management Training, Behavior Change Support, and Safety Oversight. During sessions, instructors provide hands-on correction and adjust task difficulty in real-time based on each child's motor and sensory profile. Attendance and performance are systematically recorded.
干预措施: In-Person Supervised Physical Activity Program (Behavioral)
Telehealth-delivered Physical Activity (TPA) Program
Participants' caregivers are assigned to a 16-week, theory-driven (Social Cognitive Theory and Self-Determination Theory) physical activity program delivered remotely. The intervention is co-facilitated by trained therapists via videoconference (Tencent VooV Meeting) in small cohorts (8-10 caregivers). The program consists of weekly 45-minute group sessions focused on personalized exercise prescription, collaborative goal setting, behavior change support, and safety education. Caregivers are instructed to guide their child through three 30-40 minute physical activity sessions per week and submit biweekly activity logs to a secure cloud platform. Based on these logs, therapists conduct two individualized 10-minute phone consultations per family during the intervention to provide tailored feedback and troubleshoot barriers. Each family receives a theory-informed workbook and supplemental materials.
干预措施: Telehealth-delivered Physical Activity Program for Children with ASD (Behavioral)
Standard Advice and Use (SAU)
Participants in this control arm receive general health promotion materials without a formal or structured physical activity prescription. At the beginning of the study, caregivers attend a one-time webinar-style group session covering general health topics, including pediatric nutrition, sleep hygiene, and caregiver stress management. Following the session, participants are provided with an exercise guidance manual authored by pediatric specialists for their optional, independent use. No structured or therapist-guided physical activity is provided, and there is no active monitoring.
干预措施: General Health Education Materials (Other)
结局指标
主要结局
Objective Wake After Sleep Onset
时间窗: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
This metric is the total duration, in minutes, of all periods of wakefulness that occur between the initial onset of sleep and the final awakening in the morning. Objectively calculated from accelerometer activity data, WASO serves as a direct biomarker of sleep fragmentation and an individual's ability to maintain sleep. Elevated WASO indicates disturbed, non-restorative sleep, which can disrupt sleep architecture and is often associated with daytime fatigue and impaired cognitive function.
次要结局
- Objective Total Sleep Duration(Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.)
- Objective Moderate-to-Vigorous Physical Activity (MVPA)(Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.)
- Objective Sleep Onset Latency(Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.)
- Objective Moderate-to-Vigorous Physical Activity(Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.)
- Children's Sleep Habits Questionnaire(Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.)
- Objective Sleep Efficiency(Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.)
- Objective Sedentary Behavior (SB)(Time Frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.)
- Hospital Anxiety and Depression Scale(Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.)
- Parenting Stress Scale(Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.)
- Multidimensional Scale of Perceived Social Support(Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.)
- Pittsburgh Sleep Quality Index(Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.)
- World Health Organization Quality of Life-BREF(Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.)
- Behavior Problems Inventory(Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.)
研究者
Shen Xin
Principal Investigator
Hunan Normal University