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Completed

NCT Number: NCT07066020

Telehealth Exercise Boosts Sleep and Reduces Parental Stress in Autism

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunan Normal University

Changsha, Hunan, 410000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).

Treatment and study plan

Telehealth-delivered Physical Activity Program for Children with ASD

Behavioral

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 Program

Behavioral

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 Materials

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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).

  4. 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.

    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.

  5. 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.

    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.

  6. 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.

    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.

  7. 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.

    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.

  8. 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.

    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).

  9. 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.

    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).

  10. 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.

    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).

  11. 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.

    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).

  12. 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.

    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).

  13. 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.

    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.

Sponsors and collaborators

Lead sponsor

Hunan Normal University

Other

Registry information

Official study title

A Telehealth-Delivered Physical Activity Intervention Improves Sleep and Reduces Parental Stress in Children With Autism Spectrum Disorder: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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