Telehealth Exercise Boosts Sleep and Reduces Parental Stress in Autism

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder (ASD; Sleep Disturbances in Children; Parental Stress

• Registration Number: NCT07066020
• Lead Sponsor: Hunan Normal University

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-11-01
• Study First Submitted: 2025-04-24
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-04
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Participants must meet all of the following criteria to be eligible for enrollment:

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 having bedtime resistance, sleep-onset delay, or night awakenings that occur on five to seven nights per week, as identified using the Children's Sleep Habits Questionnaire (CSHQ).

Exclusion Criteria

Participants will be excluded if they meet any of the following criteria:

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Children's Sleep Habits Questionnaire	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.
Objective Sleep Efficiency	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.
Objective Moderate-to-Vigorous Physical Activity	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.
Objective Sleep Onset Latency	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.
Objective Total Sleep Duration	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.
Objective Wake After Sleep Onset	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.
Objective Number of Awakenings	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 count of distinct awakening episodes that are recorded after sleep has initially begun and before the final morning awakening. An algorithm identifies these events by detecting significant shifts from periods of inactivity (inferred sleep) to periods of activity (inferred wakefulness). While related to WASO, this metric specifically quantifies the frequency of sleep disruptions rather than their cumulative duration. A higher

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale	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).
Parenting Stress Scale	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).
Multidimensional Scale of Perceived Social Support	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).
Pittsburgh Sleep Quality Index	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).
World Health Organization Quality of Life-BREF	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).
Behavior Problems Inventory	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).

Trial Locations

Locations (1)

Hunan Normal University; 🇨🇳 Changsha, Hunan, China