Sensory-Friendly Physical Activity for Sleep in Autistic Children

NCT ID: NCT07277101

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-01-31

Brief Summary

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.

Detailed Description

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.

Conditions

Autism Spectrum Disorder; Sleep Initiation and Maintenance Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sensory-Friendly Physical Activity Program (PAP)

Intervention Type: BEHAVIORAL

A structured, teacher-led physical activity program designed to be sensory-friendly for autistic children. Delivered in special education schools during scheduled physical education lessons, 3 sessions per week for 16 weeks. Each session includes predictable routines, warm-up, moderate-to-vigorous activities adapted for motor and sensory needs, and a cool-down with breathing and relaxation to support self-regulation and sleep readiness.

CC

Classrooms continue usual school routines

Group Type: ACTIVE_COMPARATOR

Conventional control group

Intervention Type: OTHER

Children follow the usual daily schedule

Interventions

Sensory-Friendly Physical Activity Program (PAP)

A structured, teacher-led physical activity program designed to be sensory-friendly for autistic children. Delivered in special education schools during scheduled physical education lessons, 3 sessions per week for 16 weeks. Each session includes predictable routines, warm-up, moderate-to-vigorous activities adapted for motor and sensory needs, and a cool-down with breathing and relaxation to support self-regulation and sleep readiness.

Intervention Type: BEHAVIORAL

Conventional control group

Children follow the usual daily schedule

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

(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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xili Wen

OTHER

Sponsor Role: lead

Responsible Party

Xili Wen

Principal Investigator, School of Physical Education and Training, Shanghai University of Sport

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shanghai University of Sport, School of Physical Education and Training

Shanghai, , China

Countries

China

Other Identifiers

SUS

Identifier Type: OTHER

Identifier Source: secondary_id

SUS-APA-ASD-SLEEP-RCT

Identifier Type: -

Identifier Source: org_study_id