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RECRUITING
NCT07381504
NA

Aerobic Exercise for Sleep in Children With ASD

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

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.

Official title: Acute Aerobic Exercise Intervention for Children With Autism Spectrum Disorder and Co-Occurring Sleep Disorder

Key Details

Gender

All

Age Range

3 Years - 11 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-04-15

Completion Date

2026-08-01

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

BEHAVIORAL

Intervention 1: Acute Aerobic Exercise

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.

BEHAVIORAL

Intervention 2: Parent-Mediated Cognitive Behavioral Training

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.

BEHAVIORAL

Parent Self-Education Program

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.

Locations (1)

School and Graduate of Physical Therapy

Taipei, Taiwan