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

NCT07231354 | Completed

• 1 other identifier: IHU-MST-2023-01
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder (ASD); Attention Deficit Hyperactivity Disorder (ADHD); Neurodevelopmental Disorders

Keywords

Physiotherapy; Mental Health; Children; Adolescents; Exercise Therapy; Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Change in Stress Levels (DASS-21 Stress Subscale)

  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.

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

• Change in Anxiety Levels (DASS-21 Anxiety Subscale)

  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.

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

• Change in Depression Levels (DASS-21 Depression Subscale)

  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.

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

Secondary Outcomes (2)

• Change in Autism-Related Behavioral Indicators (CAST Score)

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

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

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

Study Arms (2)

Physiotherapy Intervention Group

EXPERIMENTAL

Participants receive a structured physiotherapy program designed to improve emotional regulation, reduce anxiety symptoms, and enhance overall mental health. The program includes sensorimotor exercises, coordination training, postural activities, and structured physical activity tailored to children and adolescents with ASD or ADHD.

Behavioral: Structured Physiotherapy Program

Comparator Group

NO INTERVENTION

Participants do not receive physiotherapy during the study period but continue their usual daily routines. After study completion, they are offered the physiotherapy program.

Interventions

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.

Physiotherapy Intervention Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• International Hellenic University: lead

Study Sites (1)

Hippokratio General Hospital of Thessaloniki - Child Psychiatry Department

Thessaloniki, 546 42, Greece

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Personal Satisfaction; Behavior

Study Officials

• Illias Kallistratos

  International Hellenic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor was blinded to group assignment to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm parallel-group randomized controlled design.

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: June 28, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)