Telehealth Exercise Boosts Sleep and Reduces Parental Stress in Autism

NCT ID: NCT07066020

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

In-Person Physical Activity (In-PA) Program

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.

Group Type: ACTIVE_COMPARATOR

In-Person Supervised Physical Activity Program

Intervention Type: 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.

Telehealth-delivered Physical Activity (TPA) Program

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.

Group Type: EXPERIMENTAL

Telehealth-delivered Physical Activity Program for Children with ASD

Intervention Type: BEHAVIORAL

This is a 16-week, theory-driven (Social Cognitive Theory \& Self-Determination Theory) behavioral intervention delivered remotely to caregivers of children with ASD. The program is facilitated by trained therapists via videoconference in small groups and consists of weekly 45-minute sessions. Core components include personalized exercise prescription, collaborative goal-setting, behavior change support, and safety education. Caregivers are coached to guide their child in three 30-40 minute physical activity sessions per week. To provide individualized support, therapists conduct two 10-minute one-on-one phone consultations per family based on biweekly activity logs submitted by caregivers.

Standard Advice and Use (SAU)

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.

Group Type: OTHER

General Health Education Materials

Intervention Type: 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.

Interventions

Telehealth-delivered Physical Activity Program for Children with ASD

This is a 16-week, theory-driven (Social Cognitive Theory \& Self-Determination Theory) behavioral intervention delivered remotely to caregivers of children with ASD. The program is facilitated by trained therapists via videoconference in small groups and consists of weekly 45-minute sessions. Core components include personalized exercise prescription, collaborative goal-setting, behavior change support, and safety education. Caregivers are coached to guide their child in three 30-40 minute physical activity sessions per week. To provide individualized support, therapists conduct two 10-minute one-on-one phone consultations per family based on biweekly activity logs submitted by caregivers.

Intervention Type: BEHAVIORAL

In-Person Supervised Physical Activity Program

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.

Intervention Type: BEHAVIORAL

General Health Education Materials

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Normal University

OTHER

Sponsor Role: lead

Responsible Party

Shen Xin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hunan Normal University

Changsha, Hunan, China

Countries

China

Other Identifiers

SUS2025

Identifier Type: -

Identifier Source: org_study_id