Autism Spectrum Disorder (ASDNCT07066020
Telehealth Exercise Boosts Sleep and Reduces Parental Stress in Autism
A study testing Telehealth-delivered Physical Activity Program for Children with ASD, In-Person Supervised Physical Activity Program and General Health Education Materials in people with Autism Spectrum Disorder (ASD and Sleep Disturbances in Children, run by Hunan Normal University at 1 site in China.
Trial summary
This study aims to test whether a physical activity program delivered through telehealth can help improve sleep quality in children with autism spectrum disorder (ASD) and reduce stress and improve well-being in their parents. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD, Sleep Disturbances in Children, Parental Stress
- What is being tested?
- Telehealth-delivered Physical Activity Program for Children with ASD, In-Person Supervised Physical Activity Program and General Health Education Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The participant is a child aged 8 to 12 years with a confirmed diagnosis of Autism Spectrum Disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- A parent or primary caregiver aged 18 years or older is willing and able to participate in the study.
- The child demonstrates the ability to understand and follow simple instructions necessary for study procedures.
- Presence of significant parent-reported insomnia symptoms, specifically defined as bedtime resistance, sleep-onset delay, or night awakenings occurring on five to seven nights per week, as identified using the Children's Sleep Habits Questionnaire (CSHQ).
Who cannot join
- The participant is currently receiving, or has recently completed, pharmacological or formal behavioral treatment for sleep problems.
- Presence of any medical condition that significantly limits physical activity (e.g., moderate-to-severe asthma, congenital heart disease).
- Diagnosis of a complex neurological disorder (e.g., epilepsy).
- Presence of other known medical or psychiatric conditions that could be the primary cause of sleep disturbance (e.g., sleep apnea, restless legs syndrome, severe anxiety).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Telehealth-Delivered Physical Activity Intervention Improves Sleep and Reduces Parental Stress in Children With Autism Spectrum Disorder: A Randomized Controlled Trial
This study aims to test whether a physical activity program delivered through telehealth can help improve sleep quality in children with autism spectrum disorder (ASD) and reduce stress and improve well-being in their parents.
Children in the study will wear a small device (an accelerometer) to measure their physical activity levels and sleep. Parents will answer questionnaires about their child's sleep habits, behavior, and social skills, as well as their own sleep, stress levels, and parenting experience.
Read more
The program will be delivered remotely, allowing families to participate from their homes. It includes guided physical activities, family-based exercises, and regular telehealth support from professionals.
The goal is to find out if this type of remote support can help both children with autism and their caregivers in daily life.
- Being tested
- Telehealth-delivered Physical Activity Program for Children with ASD, In-Person Supervised Physical Activity Program, General Health Education Materials
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth-delivered Physical Activity Program for Children with ASDBehavioural
This is a 16-week, theory-informed (Social Cognitive Theory and Self-Determination Theory) caregiver-mediated physical activity intervention delivered remotely via videoconference to caregivers of children with autism spectrum disorder. Caregivers participate in 24 synchronous group sessions delivered twice weekly during weeks 1 to 8 and once weekly during weeks 9 to 16; the final session focuses on maintenance. Sessions are delivered in closed cohorts aligned with the randomized classroom clusters and cover individualized activity planning, collaborative goal setting, behavior change support, and safety education. Caregivers are instructed to facilitate at least 3 structured home-based physical activity sessions per week for their child and submit biweekly activity logs. Interventionists review logs and conduct two brief individualized telephone consultations per family to provide tailored feedback and address implementation barriers. Each family receives standardized written material
In-Person Supervised Physical Activity ProgramBehavioural
This is a 16-week, structured, in-person physical activity intervention for children with ASD. The program consists of three 40-minute sessions per week delivered on-site at a partner school by certified physical education instructors. The curriculum is manualized and includes an Individualized Motor Protocol, Structured Group Sessions, and Behavior Change Support. Instructors provide direct, hands-on correction and feedback during sessions, adjusting task difficulty in real-time to match each child's individual capabilities and needs.
General Health Education MaterialsOther
This is a minimal intervention control. Participants in this group do not receive a structured or guided physical activity program. At the beginning of the study, caregivers are provided with a one-time, webinar-style session on general pediatric health topics (e.g., nutrition, sleep hygiene) and an exercise guidance manual. These materials are for optional, independent use by the caregivers, and no active monitoring or follow-up is provided by the research team regarding their use.
| Study group | Role | What they receive |
|---|---|---|
| In-Person Physical Activity (In-PA) Program | Active comparator | Participants in this arm are assigned to a 16-week, structured, in-person physical activity regimen. Children attend three 40-minute sessions per week on-site at a partner school. Sessions are delivered by certified physical education instructors trained in a standardized protocol. The curriculum incorporates five core components: an Individualized Motor Protocol, Structured Group Sessions, Self-Management Training, Behavior Change Support, and Safety Oversight. During sessions, instructors provide hands-on correction and adjust task difficulty in real-time based on each child's motor and sensory profile. Attendance and performance are systematically recorded. Receives: Behavioral: In-Person Supervised Physical Activity Program |
| Telehealth-delivered Physical Activity (TPA) Program | Experimental | Participants' caregivers are assigned to a 16-week, theory-driven (Social Cognitive Theory and Self-Determination Theory) physical activity program delivered remotely. The intervention is co-facilitated by trained therapists via videoconference (Tencent VooV Meeting) in small cohorts (8-10 caregivers). The program consists of weekly 45-minute group sessions focused on personalized exercise prescription, collaborative goal setting, behavior change support, and safety education. Caregivers are instructed to guide their child through three 30-40 minute physical activity sessions per week and submit biweekly activity logs to a secure cloud platform. Based on these logs, therapists conduct two individualized 10-minute phone consultations per family during the intervention to provide tailored feedback and troubleshoot barriers. Each family receives a theory-informed workbook and supplemental materials. Receives: Behavioral: Telehealth-delivered Physical Activity Program for Children with ASD |
| Standard Advice and Use (SAU) | Other | Participants in this control arm receive general health promotion materials without a formal or structured physical activity prescription. At the beginning of the study, caregivers attend a one-time webinar-style group session covering general health topics, including pediatric nutrition, sleep hygiene, and caregiver stress management. Following the session, participants are provided with an exercise guidance manual authored by pediatric specialists for their optional, independent use. No structured or therapist-guided physical activity is provided, and there is no active monitoring. Receives: Other: General Health Education Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Wake After Sleep Onset
This metric is the total duration, in minutes, of all periods of wakefulness that occur between the initial onset of sleep and the final awakening in the morning. Objectively calculated from accelerometer activity data, WASO serves as a direct biomarker of sleep fragmentation and an individual's ability to maintain sleep. Elevated WASO indicates disturbed, non-restorative sleep, which can disrupt sleep architecture and is often associated with daytime fatigue and impaired cognitive function.
Measured: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Secondary outcomes (13)
Objective Total Sleep Duration
This represents the total amount of time, measured in hours, that an individual is scored as being asleep during the main nocturnal sleep period. It is distinct from "Time in Bed" because it excludes all periods of wakefulness that occur after sleep has begun (WASO). The outcome is objectively quantified using validated algorithms that analyze wrist-movement data from the accelerometer. Sufficient sleep duration is fundamental for cognitive performance, emotional regulation, and physical health, making this a critical endpoint for assessing overall sleep adequacy.
Measured: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Objective Moderate-to-Vigorous Physical Activity (MVPA)
Description: This metric represents the total amount of time spent in moderate-to-vigorous physical activity (MVPA), typically expressed in minutes per day. MVPA is derived from objective movement data collected by a wearable device and classified using a prespecified algorithm or cut points that distinguish moderate-to-vigorous activity intensity from light activity and sedentary time. This metric quantifies activity intensity exposure rather than sleep-related outcomes.
Measured: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Pittsburgh Sleep Quality Index
Parent sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). This 19-item self-report measure generates seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of these seven component scores (each rated 0-3) creates a global PSQI score that ranges from 0 to 21, with higher scores indicating poorer sleep quality (a more negative outcome).
Measured: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Objective Sleep Onset Latency
This parameter quantifies the period of time, measured in minutes, from the designated "lights out" or the beginning of the sleep attempt, to the first epoch of consolidated sleep. This is determined through an algorithmic analysis of movement data from the wearable accelerometer, which identifies the transition from an active wakeful state to a sustained resting state. SOL is a critical objective measure of sleep initiation. A prolonged SOL is a hallmark symptom of sleep-onset insomnia, making it a valuable outcome for assessing difficulties in falling asleep.
Measured: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Objective Moderate-to-Vigorous Physical Activity
The average total time per day spent in physical activities of moderate-to-vigorous intensity. This outcome is objectively quantified using a wearable accelerometer and is a key indicator of health-enhancing physical activity levels.
Measured: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Children's Sleep Habits Questionnaire
The Children's Sleep Habits Questionnaire (CSHQ) is a parent-reported tool designed to assess sleep behaviors in children aged 4 to 12. It comprises 45 items covering eight subscales: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Parents rate each item based on frequency over the past week, using a 3-point scale: "usually" (5-7 times), "sometimes" (2-4 times), or "rarely" (0-1 time). A higher total score indicates more sleep problems. The CSHQ has demonstrated good reliability and validity in identifying pediatric sleep disorders.
Measured: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Objective Sleep Efficiency
This metric represents the percentage of time spent asleep relative to the total time a person spends in bed, calculated as (Total Sleep Time / Time in Bed) x 100. The data is objectively derived from continuous actigraphy recordings captured by a wearable accelerometer. As a primary indicator of sleep consolidation, a higher sleep efficiency percentage signifies more continuous, high-quality, and less fragmented sleep. It is a key objective marker for evaluating overall sleep quality and the effectiveness of interventions aimed at improving restorative sleep.
Measured: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Hospital Anxiety and Depression Scale
Parental mood will be assessed using the Hospital Anxiety and Depression Scale (HADS). It contains 14 items, divided into a 7-item Anxiety subscale and a 7-item Depression subscale. Items are rated on a 4-point scale (0-3) based on the intensity or frequency of symptoms. Each subscale score ranges from 0 to 21, where higher scores indicate greater symptom severity for anxiety and depression, respectively (a more negative outcome).
Measured: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Parenting Stress Scale
Parenting-related stress will be evaluated using the Parenting Stress Scale (PSS). This 17-item scale measures the level of stress experienced by parents by assessing both positive and negative aspects of their parenting role. Participants rate their agreement with each statement on a 5-point scale. The total score ranges from 17 to 85, with higher scores indicating a greater level of parenting stress (a more negative outcome).
Measured: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Multidimensional Scale of Perceived Social Support
Perceived social support will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS). This 12-item scale evaluates an individual's perception of social support. Each item is rated on a 7-point scale (1 'Very Strongly Disagree' to 7 'Very Strongly Agree'). The total score ranges from 12 to 84, where higher scores indicate a greater level of perceived social support (a more positive outcome).
Measured: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
World Health Organization Quality of Life-BREF
Parental quality of life will be evaluated using the World Health Organization Quality of Life-BREF (WHOQOL-BREF). This 26-item instrument is a shorter version of the WHOQOL-100, assessing four domains: Physical Health, Psychological Health, Social Relationships, and Environment. Items are rated on a 5-point scale. For analysis, domain scores are calculated and transformed to a scale ranging from 0 to 100, where higher scores indicate a better quality of life (a more positive outcome).
Measured: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Behavior Problems Inventory
Behavioral problems will be assessed using the Behavior Problems Inventory . This 52-item instrument evaluates challenging behaviors across three subscales: Self-Injurious Behavior, Stereotyped Behavior, and Aggressive/Destructive Behavior. Each item is rated for frequency and severity on a 4-point scale from 0 (not a problem) to 3 (a severe problem). For this study, the total BPI score, representing the sum of all 52 items, will be used for analysis. The total score ranges from 0 to 156, with higher scores indicating a greater severity of behavior problems (a more negative outcome).
Measured: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Objective Sedentary Behavior (SB)
Description: This metric represents the total amount of time spent in sedentary behavior (SB), typically expressed in minutes per day. SB is derived from objective movement data collected by a wearable device and classified using a prespecified algorithm or cut points that distinguish sedentary time from light and moderate-to-vigorous physical activity. This metric quantifies low-movement waking behavior rather than sleep or physical activity intensity.
Measured: Time Frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start25 Apr 2025
- Primary completion30 Aug 2025
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASDStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a parallel assignment model with 3 groups. Intact classrooms were randomized (cluster randomization) in a 1:1:1 ratio to a telehealth-delivered, caregiver-mediated physical activity program (TPA), an in-person supervised physical activity program delivered at school (IN-PA), or standard activities as usual (SAU). Participants were child-primary caregiver dyads; eligible children were aged 8 to 12 years with autism spectrum disorder and caregiver-reported clinically significant sleep disturbance. Outcomes were assessed at baseline and follow-up time points, with the prespecified primary outcome being change in wake after sleep onset (WASO) from baseline to week 16; outcome assessors were blinded to group assignment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Xin, Hunan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066020
- Sponsor's protocol ID
- SUS2025
- Status last verified
- Nov 2026
- First submitted
- 24 Apr 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the sensitive nature of the data involving children with Autism Spectrum Disorder (ASD), individual participant data (IPD) may not be shared. This decision is based on privacy concerns, ethical considerations, and data protection regulations. Since the participants are minors, their parents have provided consent under strict confidentiality, ensuring the protection of their personal and health information.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telehealth-Delivered Physical Activity Intervention Improves Sleep and Reduces Parental Stress in Children With Autism Spectrum Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07066020
- Acronym / sponsor ID
- SUS2025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hunan Normal UniversityUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 15 Jul 2025 (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.
This study aims to test whether a physical activity program delivered through telehealth can help improve sleep quality in children with autism spectrum disorder (ASD) and reduce stress and improve well-being in their parents.
Children in the study will wear a small device (an accelerometer) to measure their physical activity levels and sleep. Parents will answer questionnaires about their child's sleep habits, behavior, and social skills, as well as their own sleep, stress levels, and parenting experience.
The program will be delivered remotely, allowing families to participate from their homes. It includes guided physical activities, family-based exercises, and regular telehealth support from professionals.
The goal is to find out if this type of remote support can help both children with autism and their caregivers in daily life.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study used a parallel assignment model with 3 groups. Intact classrooms were randomized (cluster randomization) in a 1:1:1 ratio to a telehealth-delivered, caregiver-mediated physical activity program (TPA), an in-person supervised physical activity program delivered at school (IN-PA), or standard activities as usual (SAU). Participants were child-primary caregiver dyads; eligible children were aged 8 to 12 years with autism spectrum disorder and caregiver-reported clinically significant sleep disturbance. Outcomes were assessed at baseline and follow-up time points, with the prespecified primary outcome being change in wake after sleep onset (WASO) from baseline to week 16; outcome assessors were blinded to group assignment.
| Arm | Type | Receives |
|---|---|---|
| In-Person Physical Activity (In-PA) Program | Active comparator | Behavioral: In-Person Supervised Physical Activity ProgramParticipants in this arm are assigned to a 16-week, structured, in-person physical activity regimen. Children attend three 40-minute sessions per week on-site at a partner school. Sessions are delivered by certified physical education instructors trained in a standardized protocol. The curriculum incorporates five core components: an Individualized Motor Protocol, Structured Group Sessions, Self-Management Training, Behavior Change Support, and Safety Oversight. During sessions, instructors provide hands-on correction and adjust task difficulty in real-time based on each child's motor and sensory profile. Attendance and performance are systematically recorded. |
| Telehealth-delivered Physical Activity (TPA) Program | Experimental | Behavioral: Telehealth-delivered Physical Activity Program for Children with ASDParticipants' caregivers are assigned to a 16-week, theory-driven (Social Cognitive Theory and Self-Determination Theory) physical activity program delivered remotely. The intervention is co-facilitated by trained therapists via videoconference (Tencent VooV Meeting) in small cohorts (8-10 caregivers). The program consists of weekly 45-minute group sessions focused on personalized exercise prescription, collaborative goal setting, behavior change support, and safety education. Caregivers are instructed to guide their child through three 30-40 minute physical activity sessions per week and submit biweekly activity logs to a secure cloud platform. Based on these logs, therapists conduct two individualized 10-minute phone consultations per family during the intervention to provide tailored feedback and troubleshoot barriers. Each family receives a theory-informed workbook and supplemental materials. |
| Standard Advice and Use (SAU) | Other | Other: General Health Education MaterialsParticipants in this control arm receive general health promotion materials without a formal or structured physical activity prescription. At the beginning of the study, caregivers attend a one-time webinar-style group session covering general health topics, including pediatric nutrition, sleep hygiene, and caregiver stress management. Following the session, participants are provided with an exercise guidance manual authored by pediatric specialists for their optional, independent use. No structured or therapist-guided physical activity is provided, and there is no active monitoring. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The participant is a child aged 8 to 12 years with a confirmed diagnosis of Autism Spectrum Disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- A parent or primary caregiver aged 18 years or older is willing and able to participate in the study.
- The child demonstrates the ability to understand and follow simple instructions necessary for study procedures.
- Presence of significant parent-reported insomnia symptoms, specifically defined as bedtime resistance, sleep-onset delay, or night awakenings occurring on five to seven nights per week, as identified using the Children's Sleep Habits Questionnaire (CSHQ).
Key exclusion criteria (4 listed)
- The participant is currently receiving, or has recently completed, pharmacological or formal behavioral treatment for sleep problems.
- Presence of any medical condition that significantly limits physical activity (e.g., moderate-to-severe asthma, congenital heart disease).
- Diagnosis of a complex neurological disorder (e.g., epilepsy).
- Presence of other known medical or psychiatric conditions that could be the primary cause of sleep disturbance (e.g., sleep apnea, restless legs syndrome, severe anxiety).
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 |
|---|---|---|
| Telehealth-delivered Physical Activity Program for Children with ASDThis is a 16-week, theory-informed (Social Cognitive Theory and Self-Determination Theory) caregiver-mediated physical activity intervention delivered remotely via videoconference to caregivers of children with autism spectrum disorder. Caregivers participate in 24 synchronous group sessions delivered twice weekly during weeks 1 to 8 and once weekly during weeks 9 to 16; the final session focuses on maintenance. Sessions are delivered in closed cohorts aligned with the randomized classroom clusters and cover individualized activity planning, collaborative goal setting, behavior change support, and safety education. Caregivers are instructed to facilitate at least 3 structured home-based physical activity sessions per week for their child and submit biweekly activity logs. Interventionists review logs and conduct two brief individualized telephone consultations per family to provide tailored feedback and address implementation barriers. Each family receives standardized written material | Behavioural | Telehealth-delivered Physical Activity (TPA) Program |
| In-Person Supervised Physical Activity ProgramThis is a 16-week, structured, in-person physical activity intervention for children with ASD. The program consists of three 40-minute sessions per week delivered on-site at a partner school by certified physical education instructors. The curriculum is manualized and includes an Individualized Motor Protocol, Structured Group Sessions, and Behavior Change Support. Instructors provide direct, hands-on correction and feedback during sessions, adjusting task difficulty in real-time to match each child's individual capabilities and needs. | Behavioural | In-Person Physical Activity (In-PA) Program |
| General Health Education MaterialsThis is a minimal intervention control. Participants in this group do not receive a structured or guided physical activity program. At the beginning of the study, caregivers are provided with a one-time, webinar-style session on general pediatric health topics (e.g., nutrition, sleep hygiene) and an exercise guidance manual. These materials are for optional, independent use by the caregivers, and no active monitoring or follow-up is provided by the research team regarding their use. | Other | Standard Advice and Use (SAU) |
Primary outcome
Objective Wake After Sleep Onset
Time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
This metric is the total duration, in minutes, of all periods of wakefulness that occur between the initial onset of sleep and the final awakening in the morning. Objectively calculated from accelerometer activity data, WASO serves as a direct biomarker of sleep fragmentation and an individual's ability to maintain sleep. Elevated WASO indicates disturbed, non-restorative sleep, which can disrupt sleep architecture and is often associated with daytime fatigue and impaired cognitive function.
13 secondary outcomes
Objective Total Sleep Duration
Time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Objective Moderate-to-Vigorous Physical Activity (MVPA)
Time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Pittsburgh Sleep Quality Index
Time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Objective Sleep Onset Latency
Time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Objective Moderate-to-Vigorous Physical Activity
Time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Children's Sleep Habits Questionnaire
Time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Objective Sleep Efficiency
Time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Hospital Anxiety and Depression Scale
Time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Parenting Stress Scale
Time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Multidimensional Scale of Perceived Social Support
Time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
World Health Organization Quality of Life-BREF
Time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Behavior Problems Inventory
Time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Objective Sedentary Behavior (SB)
Time frame: Time Frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. Due to the sensitive nature of the data involving children with Autism Spectrum Disorder (ASD), individual participant data (IPD) may not be shared. This decision is based on privacy concerns, ethical considerations, and data protection regulations. Since the participants are minors, their parents have provided consent under strict confidentiality, ensuring the protection of their personal and health information.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth-delivered Physical Activity Program for Children with ASD, In-Person Supervised Physical Activity Program and General Health Education Materials in people with Autism Spectrum Disorder (ASD and Sleep Disturbances in Children, run by Hunan Normal University at 1 site in China.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 3 Nov 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Wake After Sleep Onset (time frame: Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.