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Completed

NCT Number: NCT07231354

Physiotherapy for Improving Mental Health in Children and Adolescents With ASD and ADHD

This study investigates whether a structured physiotherapy program can help reduce symptoms of stress, anxiety, and depression in children and adolescents diagnosed with Autism Spectrum Disorder (ASD) or Attention-Deficit/Hyperactivity Disorder (ADHD). ASD and ADHD are neurodevelopmental conditions often associated with emotional and behavioral challenges, including elevated levels of psychological distress.

The physiotherapy intervention includes techniques such as diaphragmatic breathing, acupressure, relaxation exercises, proprioceptive activities, and therapeutic positions designed to support emotional regulation. Children aged 6-18 years are randomly assigned to either an intervention group receiving the physiotherapy program or a control group receiving usual care.

The purpose of the study is to evaluate whether this physiotherapy protocol can positively influence emotional well-being and behavioral indicators related to ASD and ADHD. Outcomes are assessed using validated questionnaires measuring stress, anxiety, depression, and disorder-related behavioral characteristics before and after the intervention.

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Key information

Conditions

Autism Spectrum Disorder (ASD) Attention Deficit Disorder with Hyperactivity Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit and Disruptive Behavior Disorders Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Personal Satisfaction Psychological Well-Being

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hippokratio General Hospital of Thessaloniki - Child Psychiatry Department

Thessaloniki, 546 42, Greece

About this study

This study examines the implementation of a structured physiotherapy program designed for children and adolescents diagnosed with Autism Spectrum Disorder (ASD) or Attention-Deficit/Hyperactivity Disorder (ADHD). The intervention includes breathing exercises, relaxation techniques, proprioceptive activities, and therapeutic postures aimed at supporting emotional regulation and reducing psychological distress.

Participants aged 6 to 18 years are randomly assigned to either an intervention group receiving the physiotherapy program or a control group receiving usual care. Standardized assessment tools are used to measure stress, anxiety, depression, and behavioral characteristics related to ASD and ADHD. The study follows a parallel-group randomized design and aims to evaluate the feasibility and potential therapeutic impact of physiotherapy-based approaches in this population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Inclusion criteria

  • Diagnosis of Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD) by a qualified clinician.
  • Age between 6 and 18 years.
  • Ability to participate in structured physiotherapy sessions.
  • Stable medication regimen (if applicable) for at least 4 weeks prior to study entry.
  • Parent/guardian consent and child assent (where applicable).
  • Ability of parents/guardians to comply with study procedures and assessments.

Exclusion criteria

  • Severe intellectual disability that prevents participation in physiotherapy activities.
  • Uncontrolled epilepsy or other neurological disorders that pose safety risks.
  • Severe sensory or motor impairments preventing safe exercise participation.
  • Participation in another clinical study within the last 3 months.
  • Any acute medical condition deemed unsafe for physical activity.
  • Behavioral issues that prevent structured participation (e.g., aggressive behavior).

Treatment and study plan

Structured Physiotherapy Program

Behavioral

A structured multimodal physiotherapy program including sensorimotor integration exercises, balance and coordination training, postural control activities, therapeutic physical activity, breathing regulation techniques, and proprioceptive stimulation. The intervention is tailored to children and adolescents with ASD or ADHD and aims to improve emotional regulation, reduce anxiety, enhance behavioral self-control, and promote overall mental health.

Primary outcomes

  1. Change in Stress Levels (DASS-21 Stress Subscale)

    Time frame: Baseline and post-intervention (after 10 sessions - approximately 5 weeks)

    Stress levels assessed using the DASS-21 Stress Subscale (score range 0-42). Higher scores indicate higher stress. The outcome will be analyzed as the change in score from baseline to post-intervention.

  2. Change in Anxiety Levels (DASS-21 Anxiety Subscale)

    Time frame: Baseline and post-intervention (after 10 sessions - approximately 5 weeks)

    Stress/anxiety levels assessed using the DASS-21 Anxiety Subscale (score range 0-42). Higher scores indicate greater anxiety symptoms. The outcome will be analyzed as the change in score from baseline to post-intervention.

  3. Change in Depression Levels (DASS-21 Depression Subscale)

    Time frame: Baseline and post-intervention (after 10 sessions - approximately 5 weeks)

    Depression levels assessed using the DASS-21 Depression Subscale (score range 0-42). Higher scores indicate higher depressive symptoms. The outcome will be analyzed as the change in score from baseline to post-intervention.

Secondary outcomes

  1. Change in Autism-Related Behavioral Indicators (CAST Score)

    Time frame: Baseline and post-intervention (after 10 sessions - approximately 5 weeks)

    Assessment of autism-related behavioral characteristics using the CAST questionnaire (score range depends on the Greek validated version). Higher scores indicate greater autism-related behavioral traits. Outcome analyzed as the change in CAST score from baseline to post-intervention.

  2. Change in ADHD-Related Behavioral Indicators (ADHD Parent Questionnaire Score)

    Time frame: Baseline and post-intervention (after 10 sessions - approximately 5 weeks)

    Assessment of ADHD-related behaviors using the ADHD Parent Questionnaire. Higher scores indicate more severe ADHD-related symptoms. Outcome analyzed as the change in score from baseline to post-intervention.

Sponsors and collaborators

Lead sponsor

International Hellenic University

Other

Registry information

Official study title

The Role of Physiotherapy in the Mental Health of Children and Adolescents With Neurodevelopmental Disorders: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

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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