Telehealth Exercise Boosts Sleep and Reduces Parental Stress in Autism

Hunan Normal University

Status: Completed

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

Treatments: Other: General Health Education Materials; Behavioral: In-Person Supervised Physical Activity Program; Behavioral: Telehealth-delivered Physical Activity Program for Children with ASD

Study type: Interventional

Funder types: Other

Identifiers

NCT07066020

SUS2025

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 3 patient groups

In-Person Physical Activity (In-PA) Program

Active Comparator group

Description:

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.

Treatment:

Behavioral: In-Person Supervised Physical Activity Program

Telehealth-delivered Physical Activity (TPA) Program

Experimental group

Description:

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.

Treatment:

Behavioral: Telehealth-delivered Physical Activity Program for Children with ASD

Standard Advice and Use (SAU)

Other group

Description:

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.

Treatment:

Other: General Health Education Materials