Sensory-Friendly Physical Activity for Sleep in Autistic Children (SFPAS)

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.

Study Overview

• Status: Completed
• Conditions: Sleep Initiation and Maintenance Disorders; Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Sensory-Friendly Physical Activity Program (PAP); Other: Conventional control group

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200438
    • Shanghai University of Sport, School of Physical Education and Training

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: CC; Classrooms continue usual school routines	Other: Conventional control group; Children follow the usual daily schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Efficiency (SE)	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.	Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Sleep Onset Latency (SOL)	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.	Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Total Sleep Time (TST)	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.	Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Wake After Sleep Onset (WASO)	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.	Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Moderate-to-Vigorous Physical Activity (MVPA)	Accelerometer-measured daily minutes of moderate-to-vigorous physical activity (MVPA). Children wear a wrist-worn accelerometer for 7 consecutive days at each assessment. Days with at least 10 hours of valid wear time are retained, and the average daily MVPA minutes are calculated. Higher values indicate greater physical activity.	Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Parental Sleep Quality (PSQI Total Score)	Caregiver-reported global sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI yields a total score ranging from 0 to 21, with higher scores indicating poorer sleep quality.	Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Parenting Sense of Competence (PSOC Total Score)	The PSOC has 16 items rated on a 6-point Likert scale, yielding a total score from 16 to 96; higher scores indicate greater parenting sense of competence.	Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Caregiver Anxiety Symptoms (HADS-A Subscale Score)	Caregiver anxiety symptoms measured by the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The subscale comprises 7 items scored 0-3, yielding a total score from 0 to 21, with higher scores indicating more severe anxiety symptoms.	Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Caregiver Depressive Symptoms (HADS-D Subscale Score)	Caregiver depressive symptoms measured by the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The subscale comprises 7 items scored 0-3, yielding a total score from 0 to 21, with higher scores indicating more severe depressive symptoms.	Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).
Caregiver Health-Related Quality of Life (WHOQOL-BREF Domain Scores)	Health-related quality of life measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF). The instrument yields four domain scores (Physical Health, Psychological Health, Social Relationships, and Environment). Domain scores are transformed to a 0-100 scale, with higher scores indicating better quality of life.	Baseline (T0), post-intervention at 16 weeks (T1), and 6-month follow-up (T2).

Collaborators and Investigators

• Sponsor: Xili Wen

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: November 30, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Actual): December 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: randomized trial; autism; insomnia; actigraphy; school-based intervention; exercise program; sleep problems; autistic children; sensory-friendly physical activity
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Sleep Disorders, Intrinsic; Dyssomnias; Autism Spectrum Disorder; Parasomnias; Autistic Disorder; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: SUS-APA-ASD-SLEEP-RCT; SUS (Other Identifier: Shanghai University of Sport)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No