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 (1)

• 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

Secondary Outcomes (7)

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

  Baseline and post-intervention at Week 2

• Continuous Performance Test (CPT)

  Baseline and post-intervention at Week 2

• Physical activity assessment

  Baseline and post-intervention at Week 2

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

  Baseline and post-intervention at Week 2

• Repetitive Behavior Scale-Revised (RBS-R)

  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: July 31, 2026
• Study Completion: August 1, 2026
• Last Updated: July 14, 2026

Record last verified: 2025-12

Locations

TW (1)