# Effectiveness of a five-component multimodal intervention on executive function in children with Autism spectrum disorder: A study protocol for a randomized controlled trial

## TL;DR

This study tests a five-part exercise program to improve thinking skills in children with autism, aiming to help them function better in daily life.

## Contribution

The study introduces a novel, low-cost, non-drug multimodal intervention targeting multiple executive function domains in children with ASD.

## Key findings

- The trial will assess executive function improvements using standardized cognitive tasks.
- Results may guide the adoption of structured exercise programs in rehabilitation and educational settings.
- Findings could support future large-scale studies and standardized intervention guidelines for ASD.

## Abstract

Autism Spectrum Disorder (ASD) is characterized by persistent deficits in social interaction, communication, and executive functions such as inhibitory control, cognitive flexibility, and working memory. These deficits hinder daily functioning and learning outcomes in children. Exercise-based interventions improve executive function; however, most previous studies have focused on single-modality programs with limited generalizability. This trial aims to evaluate the effectiveness of a structured, five-component multimodal intervention—comprising yoga, aerobic, strengthening, neurocognitive, and music-based mindfulness activities—on improving executive functioning in children with ASD.

This assessor-blinded, double-center randomized controlled trial will enroll 130 children aged 4–18 years diagnosed with ASD in Bangladesh. Participants will be randomly assigned (1:1) to either the experimental group receiving the multimodal intervention or a wait-list control group receiving healthy lifestyle guidelines. The intervention will include five supervised sessions per week for 12 weeks, followed by a 12-week follow-up. An additional group of 65 typically developing children will serve as healthy controls. Primary outcomes will assess executive function domains: inhibitory control (Go/No-Go Task), cognitive flexibility (Trail Making Test A–B), and working memory (Corsi Block Tapping Task; Forward and Backward Digit Span). Secondary outcomes include social responsiveness (Social Responsiveness Scale–2) and ASD-related behaviors (Autism Treatment Evaluation Checklist). Outcomes will be evaluated at baseline, 12 weeks, and 24 weeks by blinded assessors. Data will be analyzed using SPSS following the intention-to-treat principle.

This trial will address an important evidence gap by evaluating a comprehensive, low-cost, non-pharmacological multimodal intervention targeting multiple domains of executive function in children with ASD. The findings may help clinicians, educators, and policymakers adopt structured exercise-based programs within rehabilitation, school, and community settings. Although limited to two centers, the results could guide future large-scale studies and support the development of standardized multimodal intervention guidelines for ASD.

This trial is prospectively registered with the Clinical Trial Registry of India: CTRI/2025/11/096943 [Registered on: 06/11/2025]. Link: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTQ1NDEy&Enc=&userName=