Aerobic Exercise for Sleep in Children With ASD

NCT07381504 | Recruiting

• 1 other identifier: 202407160RINE
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by impairments in social interaction and communication. Children with ASD frequently experience co-occurring behavioral problems, among which sleep disturbances are highly prevalent, affecting approximately 40%-80% of children and adolescents with ASD. These sleep problems pose a substantial burden during childhood and adolescence. This study employs a two-phase design to examine the effects of an acute aerobic exercise intervention combined with a parent-mediated cognitive behavioral program on sleep problems in children with autism spectrum disorder (ASD). Phase 1 consists of cross-sectional assessments comparing sleep efficiency, physical fitness, and attentional performance among children with ASD with and without sleep problems and typically developing children. Phase 2 is a randomized controlled intervention trial involving children with ASD and comorbid sleep problems, in which participants are assigned to either an aerobic exercise plus cognitive behavioral intervention group or a control group receiving cognitive behavioral strategy materials only. The intervention lasts two weeks. Outcomes related to autistic symptoms, sleep efficiency, physical activity level, attentional performance , and adaptive behaviors are assessed before and after the intervention to evaluate intervention effects.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Sleep Disorders; Acute Aerobic Exercise; Physical Fitness; Children

Outcome Measures

Primary Outcomes (8)

• Sleep Efficiency Assessed by Actigraphy

  Sleep efficiency will be calculated as the percentage of total sleep time divided by time in bed, measured using wrist-worn actigraphy.

  Baseline and post-intervention at Week 2

• Social Responsiveness Scale, Second Edition (SRS-2)

  Social functioning and autism-related social impairments were assessed using the Social Responsiveness Scale, Second Edition (SRS-2). The SRS-2 is a standardized, caregiver-report questionnaire designed to quantify the severity of social communication deficits and restricted and repetitive behaviors associated with autism spectrum disorder. The scale consists of 65 items rated on a 4-point Likert scale, with higher scores indicating greater levels of social impairment. Raw scores were converted to age- and sex-normed T-scores according to the test manual, yielding a total score and five subscale scores: Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behavior. Higher scores indicating greater severity of autism-related social impairments.

  Baseline and post-intervention at Week 2

• Continuous Performance Test (CPT)

  Attentional performance was assessed using the Continuous Performance Test (CPT), a computerized task designed to evaluate sustained attention and inhibitory control. During the test, children were required to respond to target stimuli and withhold responses to non-target stimuli over a continuous period of time. Key outcome measures included omission errors (failures to respond to target stimuli), commission errors (responses to non-target stimuli), reaction time, and reaction time variability, which together reflect attentional capacity, impulsivity, and response consistency.

  Baseline and post-intervention at Week 2

• Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)

  Adaptive functioning was assessed using the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3). The Vineland-3 is a standardized caregiver-report measure designed to evaluate adaptive behaviors required for daily functioning across developmental domains. The assessment yields standard scores for the Adaptive Behavior Composite and domain scores for Communication, Daily Living Skills, Socialization, and Motor Skills, based on age-normed data. Higher scores indicate better adaptive functioning.

  Baseline and post-intervention at Week 2

• Chinese Version of the Children's Sleep Habits Questionnaire- Autism (CSHQ-Autism)

  Sleep behaviors were assessed using the Chinese version of the Children's Sleep Habits Questionnaire-Autism (CSHQ-Autism), a caregiver-reported questionnaire specifically adapted to evaluate sleep habits and sleep-related problems in children with autism spectrum disorder. The questionnaire consists of multiple items rated on a Likert-type scale, yielding a total sleep disturbance score and domain-specific scores reflecting common sleep difficulties, such as bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Higher scores indicate more severe sleep problems.

  Baseline and post-intervention at Week 2

• Repetitive Behavior Scale-Revised (RBS-R)

  Restricted and repetitive behaviors were assessed using the Repetitive Behavior Scale-Revised (RBS-R), a caregiver-reported questionnaire designed to quantify the presence and severity of repetitive and stereotyped behaviors commonly observed in individuals with autism spectrum disorder. The RBS-R consists of multiple items rated on a Likert-type scale, yielding a total score and subscale scores reflecting distinct domains of repetitive behavior, including Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Ritualistic Behavior, Sameness Behavior, and Restricted Interests. Higher scores indicate greater severity of repetitive behavior symptoms.

  Baseline and post-intervention at Week 2

• Chinese Version of Obstructive Sleep Apnea-18 Questionnaire (OSA-18)

  Sleep-disordered breathing-related quality of life was assessed using the Chinese version of the Obstructive Sleep Apnea-18 Questionnaire (OSA-18), a caregiver-reported instrument designed to evaluate the impact of obstructive sleep apnea symptoms on children's daily functioning and well-being. The questionnaire consists of 18 items rated on a Likert-type scale, yielding a total score and five domain scores: Sleep Disturbance, Physical Symptoms, Emotional Distress, Daytime Functioning, and Caregiver Concerns. Higher scores indicate greater symptom burden and poorer sleep-related quality of life.

  Baseline and post-intervention at Week 2

• Physical activity assessment

  Children's physical activity level was assessed using a caregiver-reported diary, which captured the frequency and duration of children's engagement in daily physical activities. This measure provided an estimate of overall physical activity participation, including total activity duration and time spent in daily activities.

  Baseline and post-intervention at Week 2

Study Arms (2)

Aerobic-Cognitive Behavioral Integrated Intervention (ACBI) program

EXPERIMENTAL

The Aerobic-Cognitive Behavioral Integrated Intervention (ACBI) combines supervised moderate-to-vigorous aerobic exercise (twice weekly, 30 minutes per session for 2 weeks) with a parent-mediated cognitive behavioral component targeting sleep-related behaviors. Exercise intensity is monitored using heart rate-based criteria. Parents receive structured guidance and implement cognitive behavioral strategies daily at home throughout the intervention period.

Behavioral: Intervention 1: Acute Aerobic Exercise; Behavioral: Intervention 2: Parent-Mediated Cognitive Behavioral Training

Control group

ACTIVE COMPARATOR

Provision of written materials describing cognitive behavioral strategies for managing sleep-related behaviors in children with ASD. No structured training sessions or supervised implementation are provided.

Behavioral: Parent Self-Education Program

Interventions

Parent Self-Education Program BEHAVIORAL

Children with ASD in the control group were provided with a Cognitive Behavioral Strategy Information, in which parents received written materials describing cognitive behavioral strategies relevant to supporting children's self-regulation and daily behaviors. Parents were encouraged to review the materials and apply the strategies at home as they deemed appropriate. No structured training sessions or supervised implementation were provided.

Control group

Intervention 1: Acute Aerobic Exercise BEHAVIORAL

Moderate-to-vigorous-intensity intermittent aerobic exercise conducted twice per week, 30 minutes per session, over a 2-week period. Exercise intensity is prescribed and monitored using heart rate-based criteria. All sessions are supervised by trained research staff.

Aerobic-Cognitive Behavioral Integrated Intervention (ACBI) program

Intervention 2: Parent-Mediated Cognitive Behavioral Training BEHAVIORAL

Structured parent training in cognitive behavioral strategies targeting sleep-related behaviors, including sleep routines, environmental modifications, and behavioral reinforcement techniques. Parents are instructed to implement strategies daily at home throughout the intervention period.

Aerobic-Cognitive Behavioral Integrated Intervention (ACBI) program

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3-11 years
• Clinical diagnosis of Autism Spectrum Disorder and a comorbid sleep disorder
• No diagnosis of genetic or chromosomal disorders, such as Down syndrome or Fragile X syndrome.

You may not qualify if:

• Children with physical disabilities or visual or hearing impairments
• Children who are unable to participate in vigorous physical activity due to any medical condition
• Children with other psychiatric disorders.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

School and Graduate of Physical Therapy

Taipei, 10055, Taiwan

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yen-Tzu Wu, PhD

CONTACT

+8862963663269; yenwu@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: February 2, 2026
• Study Start: April 15, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2025-12

Locations

TW (1)