Sensory-friendly Physical Activity and Sleep in Autistic Children: 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
- 106
- 试验地点
- 2
- 主要终点
- Sleep Efficiency (SE)
研究概览
简要总结
Sleep problems are very common in children on the autism spectrum and can worsen daytime behaviour, learning, and family stress. Many families have limited access to specialist sleep services. This study evaluates a school-based, sensory-friendly physical activity program designed to improve sleep and wellbeing in autistic children.
This multicenter, parallel-group, randomized controlled trial was conducted in special education schools in China. Classrooms of children aged 7-12 years with a diagnosis of autism spectrum disorder were randomly assigned to either: (1) a teacher-led, sensory-friendly physical activity program integrated into regular physical education lessons for 16 weeks, or (2) usual school activities without the program. The intervention emphasized predictable routines, gradual warm-up, adjusted sensory input (for example, noise and light), and calming cool-down activities to support self-regulation and readiness for sleep.
The primary outcomes are children's sleep parameters measured by wrist actigraphy, including sleep efficiency, sleep onset latency, sleep duration, and wake after sleep onset. Secondary outcomes include parent-reported sleep problems, children's daily moderate-to-vigorous physical activity, and caregivers' sleep quality, mental health, parenting sense of competence, and quality of life. Outcomes are assessed at baseline, immediately after the 16-week program, and 6 months after the program ends.
详细描述
This study is a multicenter, parallel-group, randomized controlled trial conducted in special education schools in China. Classrooms are the unit of randomization to minimize contamination between children in the same class. Eligible participants are children aged 7-12 years with a documented diagnosis of autism spectrum disorder who attend participating special schools, have at least one sleep difficulty (such as bedtime resistance, prolonged sleep onset, or night wakings), and live with a primary caregiver who can complete questionnaires in Mandarin and provide informed consent.
Classes are randomly assigned in a 1:1 ratio to either the sensory-friendly Physical Activity Program (PAP) or a control condition. The PAP is delivered by trained physical education teachers during scheduled lessons, three times per week for 16 weeks. Each session includes a structured warm-up, multi-component physical activities adapted for motor and sensory needs, and a cool-down segment with breathing and relaxation exercises in a low-arousal environment. Teachers receive manuals and on-site coaching to support fidelity. The control group follows usual school routines and physical education without the PAP.
The primary outcomes are actigraphy-derived sleep parameters: sleep efficiency, sleep onset latency, total sleep time, and wake after sleep onset. Secondary outcomes include accelerometer-measured daily physical activity; parent-reported sleep problems; and caregiver-reported sleep quality, anxiety and depressive symptoms, parenting sense of competence, and health-related quality of life. Data are collected at three time points: baseline (before randomization), immediately after the 16-week intervention, and 6-month follow-up. Linear mixed-effects models with random intercepts for classroom and child are used to estimate intervention effects while accounting for clustering and prespecified covariates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility criteria Child inclusion criteria(1) Aged 7-12 years with a documented DSM-5 diagnosis of autism spectrum disorder in school records.(2) Able to understand and execute two-step instructions, as confirmed by the classroom special-education teacher.(3) Parent-reported sleep problems on the Children's Sleep Habits Questionnaire (CSHQ), operationalised as ≥ 5 nights per week of bedtime resistance, sleep onset delay, or night wakings.
- •Caregiver inclusion criteria (1) Identified as the child's primary caregiver in daily life.(2) Fluent in Mandarin (speaking, listening, reading, and writing), as all intervention and assessments were conducted in Mandarin.(3) ≥ 18 years of age.(4) Provided written informed consent and agreed to random allocation.
排除标准
- •(1) Current or prior pharmacological or behavioural treatment specifically targeting sleep.(2) Medical conditions that preclude participation in physical activity (e.g., asthma, congenital heart disease).(3) Comorbid complex neurological disorders (e.g., epilepsy) or other medical/psychiatric conditions likely to interfere with sleep.
研究组 & 干预措施
CC
Classrooms continue usual school routines
干预措施: Conventional control group (Other)
PAP
Classrooms receive a teacher-led, sensory-friendly physical activity program integrated into regular physical education lessons, 3 times per week for 16 weeks. Sessions include structured warm-up, adapted multi-component activities, and calming cool-down with breathing and relaxation in a low-arousal environment.
干预措施: Sensory-Friendly Physical Activity Program (PAP) (Behavioral)
结局指标
主要结局
Sleep Efficiency (SE)
时间窗: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Actigraphy-derived sleep efficiency, calculated as (total sleep time / time in bed) × 100%, averaged across at least 3 consecutive nights at each assessment. Higher scores indicate more efficient sleep.
Sleep Onset Latency (SOL)
时间窗: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Actigraphy-derived sleep onset latency, defined as the number of minutes from lights out (bedtime) to the onset of sustained sleep, averaged across at least 3 consecutive nights at each assessment. Lower scores indicate faster sleep initiation.
Total Sleep Time (TST)
时间窗: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Actigraphy-derived total sleep time, defined as the total number of minutes scored as sleep between sleep onset and final morning waking, averaged across at least 3 consecutive nights at each assessment. Higher scores indicate longer nocturnal sleep duration.
Wake After Sleep Onset (WASO)
时间窗: Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Actigraphy-derived wake after sleep onset, defined as the cumulative number of minutes scored as wake after initial sleep onset until final morning waking, averaged across at least 3 consecutive nights at each assessment. Lower scores indicate less fragmented sleep.
次要结局
- Parenting Sense of Competence (PSOC Total Score)(Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).)
- Caregiver Depressive Symptoms (HADS-D Subscale Score)(Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).)
- Caregiver Health-Related Quality of Life (WHOQOL-BREF Domain Scores)(Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).)
- Daily Moderate-to-Vigorous Physical Activity (MVPA)(Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).)
- Caregiver Anxiety Symptoms (HADS-A Subscale Score)(Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).)
- Parental Sleep Quality (PSQI Total Score)(Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).)
研究者
Xili Wen
Principal Investigator, School of Physical Education and Training, Shanghai University of Sport
Shanghai University of Sport