Autism Spectrum DisorderNCT07381504
Aerobic Exercise for Sleep in Children With ASD
A study testing Intervention 1: Acute Aerobic Exercise, Intervention 2: Parent-Mediated Cognitive Behavioral Training and Parent Self-Education Program in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Intervention 1: Acute Aerobic Exercise, Intervention 2: Parent-Mediated Cognitive Behavioral Training and Parent Self-Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Apr 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
School and Graduate of Physical Therapy
Taipei, 10055
Yen-Tzu Wu, PhD, 886-2963663269, yenwu@ntu.edu.tw
About this study
Official title: Acute Aerobic Exercise Intervention for Children With Autism Spectrum Disorder and Co-Occurring Sleep Disorder
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.
Read the detailed 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Intervention 1: Acute Aerobic Exercise, Intervention 2: Parent-Mediated Cognitive Behavioral Training, Parent Self-Education Program
- Keywords
- Autism Spectrum Disorder, Sleep Disorders, Acute Aerobic Exercise, Physical Fitness, Children
- Medical subject headings
- Autism Spectrum Disorder, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1: Acute Aerobic ExerciseBehavioural
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.
Intervention 2: Parent-Mediated Cognitive Behavioral TrainingBehavioural
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.
Parent Self-Education ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Parent Self-Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post-intervention at Week 2
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and post-intervention at Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start15 Apr 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381504
- Sponsor's protocol ID
- 202407160RINE
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lu PT, Yang CY, Huang FY, Chen YC, Chang JC, Cheong PL, Wu YT. Interval-Based Aerobic Exercise and Behavioral Intervention for Sleep Disturbances in Children With Autism Spectrum Disorder: A Randomized Controlled Trial. Autism Res. 2026 Aug 30:e70361. doi: 10.1002/aur.70361. Online ahead of print.
PubMed 42669612
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Aerobic Exercise Intervention for Children With Autism Spectrum Disorder and Co-Occurring Sleep Disorder
- ClinicalTrials.gov ID
- NCT07381504
- Acronym / sponsor ID
- 202407160RINE
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Sleep Disorders, Acute Aerobic Exercise, Physical Fitness, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic-Cognitive Behavioral Integrated Intervention (ACBI) program | Experimental | Behavioral: Intervention 1: Acute Aerobic Exercise, Behavioral: Intervention 2: Parent-Mediated Cognitive Behavioral TrainingThe 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. |
| Control group | Active comparator | Behavioral: Parent Self-Education ProgramProvision 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. |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1: Acute Aerobic ExerciseModerate-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. | Behavioural | Aerobic-Cognitive Behavioral Integrated Intervention (ACBI) program |
| Intervention 2: Parent-Mediated Cognitive Behavioral TrainingStructured 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. | Behavioural | Aerobic-Cognitive Behavioral Integrated Intervention (ACBI) program |
| Parent Self-Education ProgramChildren 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. | Behavioural | Control group |
Primary outcome
Sleep Efficiency Assessed by Actigraphy
Time frame: Baseline and post-intervention at Week 2
Sleep efficiency will be calculated as the percentage of total sleep time divided by time in bed, measured using wrist-worn actigraphy.
7 secondary outcomes
Social Responsiveness Scale, Second Edition (SRS-2)
Time frame: Baseline and post-intervention at Week 2
Continuous Performance Test (CPT)
Time frame: Baseline and post-intervention at Week 2
Physical activity assessment
Time frame: Baseline and post-intervention at Week 2
Chinese Version of Obstructive Sleep Apnea-18 Questionnaire (OSA-18)
Time frame: Baseline and post-intervention at Week 2
Repetitive Behavior Scale-Revised (RBS-R)
Time frame: Baseline and post-intervention at Week 2
Chinese Version of the Children's Sleep Habits Questionnaire- Autism (CSHQ-Autism)
Time frame: Baseline and post-intervention at Week 2
Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Time frame: Baseline and post-intervention at Week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Derived from this study: PubMed 42669612Lu PT, Yang CY, Huang FY, Chen YC, Chang JC, Cheong PL, Wu YT. Interval-Based Aerobic Exercise and Behavioral Intervention for Sleep Disturbances in Children With Autism Spectrum Disorder: A Randomized Controlled Trial. Autism Res. 2026 Aug 30:e70361. doi: 10.1002/aur.70361. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1: Acute Aerobic Exercise, Intervention 2: Parent-Mediated Cognitive Behavioral Training and Parent Self-Education Program in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yen-Tzu Wu, PhD (+8862963663269, yenwu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency Assessed by Actigraphy (time frame: Baseline and post-intervention at Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07381504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.