Telehealth Exercise Boosts Sleep and Reduces Parental Stress in Autism

NCT07066020 | Completed

• 1 other identifier: SUS2025
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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)

  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

  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

  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

  Measurements will be taken at baseline (pre-intervention), after the 16-week intervention, and at 6-month and 12-month post-intervention follow-ups.

Study Arms (3)

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.

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.

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.

Other: General Health Education Materials

Interventions

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.

In-Person Physical Activity (In-PA) Program

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

Telehealth-delivered Physical Activity (TPA) Program

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.

Standard Advice and Use (SAU)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hunan Normal University: lead

Study Sites (1)

Hunan Normal University

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: July 15, 2025
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)