Aerobic Exercise for Sleep in Children With ASD

National Taiwan University

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Intervention 1: Acute Aerobic Exercise; Behavioral: Parent Self-Education Program; Behavioral: Intervention 2: Parent-Mediated Cognitive Behavioral Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07381504

202407160RINE

Details and patient eligibility

About

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.

Full description

This study employs a two-phase design to investigate 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). In Phase 1, cross-sectional assessments of sleep efficiency, physical fitness, and attentional performance will be conducted among children with ASD with and without sleep problems, as well as typically developing children. Phase 2 consists of a randomized intervention trial involving children with ASD and comorbid sleep problems.

During Phase 2, Eligible participants will be randomly assigned to one of two groups: (1) an acute aerobic exercise combined with cognitive behavioral intervention group, or (2) a control group receiving cognitive behavioral strategies only. The intervention period will last two weeks.

The acute aerobic exercise program will consist of moderate-to-vigorous-intensity intermittent aerobic exercise conducted twice per week, with each session lasting 30 minutes. Exercise intensity will be monitored and prescribed using standardized heart rate-based criteria to ensure participant safety and adherence to the target intensity range. Exercise sessions will be supervised by trained research staff.

The cognitive behavioral component is parent-mediated. Parents in both groups will receive structured training in cognitive behavioral strategies targeting sleep-related behaviors, including sleep routines, environmental modifications, and behavioral reinforcement techniques. Parents will be instructed to implement these strategies consistently at home on a daily basis throughout the intervention period. Adherence to the intervention will be monitored through parental reports and regular communication with the research team.

Outcome measures, including autistic symptoms, sleep efficiency, physical activity level, attentional performance and adaptive behaviors, will be assessed before and after the intervention to evaluate the effectiveness of the two intervention approaches.

Enrollment: 120 estimated patients

Sex: All

Ages: 3 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Aerobic-Cognitive Behavioral Integrated Intervention (ACBI) program

Experimental group

Description:

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.

Treatment:

Behavioral: Intervention 2: Parent-Mediated Cognitive Behavioral Training

Behavioral: Intervention 1: Acute Aerobic Exercise

Control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Parent Self-Education Program