Protocol for Global Integration Method in children with ASD aged 6 to 12 years

IntroductionMotor impairments are highly prevalent in children with Autism Spectrum Disorder (ASD) and have been associated with reduced functional independence, participation, and sociocommunicative development. Despite the growing body of evidence supporting the relevance of motor functioning in ASD, motor-based interventions remain underrepresented in high-quality randomized clinical trials. The Global Integration Method (Método de Integração Global - MIG) is an intensive, interdisciplinary intervention grounded in the theories of predictive coding and embodied cognition, with emphasis on motor organization, proprioceptive stimulation, and generalization of functional skills in real-life contexts.ObjectiveThe aim of this study is to evaluate the effectiveness of the MIG program in improving fundamental motor skills and achieving functional goals, compared with conventional physiotherapy and psychological interventions, in children with ASD. Secondary objectives are to investigate the effects of MIG on balance, sociocommunicative skills, and motor performance.Methods and analysisThis is a three-arm randomized controlled trial with concealed allocation and blinded outcome assessors. Sixty-six children with ASD, aged 6 to 12 years, classified as requiring level 1 or 2 support, will be randomized into one of three groups: (I) MIG program, (II) conventional psychological intervention, and (III) conventional motor physiotherapy. Interventions will last five weeks. Assessments will be conducted at baseline, immediately post-intervention, and three months after completion. Primary outcomes include fundamental motor skills and functional goal attainment. Secondary outcomes include measures of balance, sociocommunicative skills, and motor performance. Data will be analyzed using linear mixed-effects models, following the intention-to-treat principle.Ethics and disseminationThe protocol was approved by the Research Ethics Committee of the Faculty of Medical Sciences of Minas Gerais, Brazil (Approval No. 7,456,658). Written informed consent will be obtained from parents or legal guardians, and assent will be sought from participating children when developmentally appropriate. Study findings will be disseminated through peer-reviewed publications, conference presentations, and reports to participating families and institutions.Clinical Trial RegistrationThis protocol was prospectively registered in the Brazilian Registry of Clinical Trials https://ensaiosclinicos.gov.br/rg/RBR-7r6n8zd, identifier U1111-1326-2272.