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Sensory-friendly Physical Activity and Sleep in Autistic Children: A Randomized Controlled Trial
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, cluster-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.
This study is a multicenter, parallel-group, cluster-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.
Age
7 - 12 years
Sex
ALL
Healthy Volunteers
No
Shanghai University of Sport, School of Physical Education and Training
Shanghai, China
Start Date
June 1, 2023
Primary Completion Date
January 31, 2025
Completion Date
January 31, 2025
Last Updated
December 11, 2025
106
ACTUAL participants
Sensory-Friendly Physical Activity Program (PAP)
BEHAVIORAL
Conventional control group
OTHER
Lead Sponsor
Xili Wen
NCT06290258
NCT05750095
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05874466