Study Protocol for a Single-center Randomized Clinical Trial: Evaluating the Effectiveness of Combined Therapy versus Conventional Therapy Approaches to Improve Physical & Behavioral Status among Children with Autism Spectrum Disorder
Abstract
Objective: Currently, traditional Autism Spectrum Disorder (ASD) treatments include occupational therapy and speech and language therapy (SLT), however, physiotherapy has little evidence of efficacy. Hence, this study aims to compare physiotherapy, occupational therapy as well as speech and language therapy as need-based interventions for ASD patients with physical and behavioral deficits.
Material and Methods: An assessor and participant blinded randomized clinical trial (RCT) was designed for 70 cases diagnosed with ASD, according to Diagnostic and Statistical Manual of Mental Disorders (DSM) V, from July 2024 to April 2025, with each being randomly assigned to either Group A or Group B. Participants of Group A will receive physiotherapy plus occupational therapy with SLT and group B will receive only occupational therapy plus speech and language therapy for 4 weeks. The outcome of this study will be physical status determined by modified SF-36 scores and behavioral status via GARS-3 scores. The study site will be Proyash (an Institute of Special Education), Jashore Area, Bangladesh. Study analysis will be conducted according to the nature of the data, and will include intention-to- treat analysis.
Results: The results of this study are expected to determine that comprehensive multidisciplinary practices of ASD can advocate the benefits for children and adolescents with ASD, the parents, other stakeholders and special schools throughout Bangladesh.
Conclusion: This study will address the research gap on the impact of the outcome of physiotherapy interventions, along with occupational therapy with SLT, on behavioral and physical status for the participants of ASD.
Keywords
Full Text:
PDFReferences
Lyall K, Croen L, Daniels J, Fallin MD, Ladd-Acosta C, Lee BK, et al. The changing epidemiology of autism spectrum disorders. Annu Rev Public Health 2017;38:81-102.
Long D, Yang T, Chen J, Dai Y, Chen L, Jia F, et al. Age of Diagnosis and demographic factors associated with autism spectrum disorders in chinese children: a multi-center survey. Neuropsychiatr Dis Treat 2022;18:3055-65.
Akhter S, Hussain AE, Shefa J, Kundu GK, Rahman F, Biswas A. Prevalence of autism spectrum disorder (ASD) among the children aged 18-36 months in a rural community of Bangladesh: a cross sectional study. F1000Res 2018;7:424.
Khatun R, Bin Siddique MK, Khatun MR, Benzir M, Islam MR, Ahmed S, et al. Nutritional status of children with neurodevelopmental disorders: a cross-sectional study at a tertiary-level hospital in northern Bangladesh. BMC Nutr 2024;10:61.
Tian J, Gao X, Yang L. Repetitive restricted behaviors in autism spectrum disorder: From mechanism to development of therapeutics. Front Neurosci 2022;16:780407.
Li YA, Chen ZJ, Li XD, Gu MH, Xia N, Gong C, et al. Epidemiology of autism spectrum disorders: Global burden of disease 2019 and bibliometric analysis of risk factors. Front Pediatr 2022;10:972809.
Williams DL, Siegel M, Mazefsky CA. Problem behaviors in autism spectrum disorder: association with verbal ability and adapting/coping skills. J Autism Dev Disord 2018;48:3668-77.
Zablotsky B, Black LI, Blumberg SJ. Estimated prevalence of children with diagnosed developmental disabilities in the United States, 2014-2016. NCHS Data Brief 2017;291:1-8.
Loomes R, Hull L, Mandy WP. What is the male-to-female ratio in autism spectrum disorder? A systematic review and meta-analysis. J Am Acad Child Adolesc Psychiatry 2017;56:466-74.
Must A, Curtin C, Hubbard K, Sikich L, Bedford J, Bandini L. Obesity prevention for children with developmental disabilities. Curr Obes Rep 2014;3:156-70.
Burns CO, Matson JL. An evaluation of the clinical application of the DSM-5 for the diagnosis of autism spectrum disorder. Expert Rev Neurother 2017;17:909-17.
Broder-Fingert S, Brazauskas K, Lindgren K, Iannuzzi D, Van Cleave J. Prevalence of overweight and obesity in a large clinical sample of children with autism. Acad Pediatr 2014;14:408-14.
Gharehgazlou A, Vandewouw M, Ziolkowski J, Wong J, Crosbie J, Schachar R, et al. Cortical gyrification morphology in ASD and ADHD: implication for further similarities or disorder-specific features? Cereb Cortex 2022;32:2332-42.
Jackson SL, Abel EA, Reimer S, McPartland JC. Brief report: a specialized fitness program for individuals with autism spectrum disorder benefits physical, behavioral, and emotional outcomes. J Autism Dev Disord 2024;54:2402-10.
Batey CA, Missiuna CA, Timmons BW, Hay JA, Faught BE, Cairney J. Self-efficacy toward physical activity and the physical activity behavior of children with and without Developmental Coordination Disorder. Hum Mov Sci 2014;36:258-71.
Alhowikan AM, Elamin NE, Aldayel SS, AlSiddiqi SA, Alrowais FS, Hassan WM, et al. Children with autism spectrum disorder exhibit elevated physical activity and reduced sedentary behavior. Brain Sci 2023;13:1575.
Oriel KN, George CL, Peckus R, Semon A. The effects of aerobic exercise on academic engagement in young children with autism spectrum disorder. Pediatr Phys Ther 2011;23:187-93.
Ferreira JP, Ghiarone T, Cabral Junior CR, Furtado GE, Moreira Carvalho H, Machado-Rodrigues AM, et al. Effects of physical exercise on the stereotyped behavior of children with autism spectrum disorders. Medicina 2019;55:685.
Samadi SA, Biçak CA, Noori H, Abdalla B, Abdullah A, Ahmed L. Autism spectrum disorder diagnostic criteria changes and impacts on the diagnostic scales-utility of the 2nd and 3rd versions of the Gilliam Autism Rating Scale (GARS). Brain Sci 2022;12:537.
Akter R, Urme NA, Hossain KA, Hossain T, Ahammad S, Yeasmin MH, et al. Protocol for a randomized clinical trial comparing the efficacy of Structured Diet (SD) and Regular Therapy (RT) for adolescents with malnutrition having Autism Spectrum Disorder (ASD). PLoS One 2023;18:e0292326.
Huerta M, Bishop SL, Duncan A, Hus V, Lord C. Application of DSM-5 criteria for autism spectrum disorder to three samples of children with DSM-IV diagnoses of pervasive developmental disorders. Am J Psychiatry 2012;169:1056-64.
Wiggins LD, Rice CE, Barger B, Soke GN, Lee LC, Moody E, et al. DSM-5 criteria for autism spectrum disorder maximizes diagnostic sensitivity and specificity in preschool children. Soc Psychiatr Epidemiol 2019;54:693-701.
Faruk MO, Rahman MS, Rana MS, Mahmud S, Al-Neyma M, Karim MS, et al. Socioeconomic and demographic risk factors of autism spectrum disorder among children and adolescents in Bangladesh: evidence from a cross-sectional study in 2022. PLoS One 2023;18:e0289220.
Moulton E, Bradbury K, Barton M, Fein D. Factor analysis of the childhood autism rating scale in a sample of two year olds with an autism spectrum disorder. J Autism Dev Disord 2019;49:2733-46.
Lord C, Elsabbagh M, Baird G, Veenstra-Vanderweele J. Autism spectrum disorder. Lancet 2018;392:508-20.
Khan NZ, Gallo LA, Arghir A, Budisteanu B, Budisteanu M, Dobrescu I, et al. Autism and the grand challenges in global mental health. Autism Res 2012;5:156-9.
Gulati S, Kaushik JS, Saini L, Sondhi V, Madaan P, Arora NK, et al. Development and validation of DSM-5 based diagnostic tool for children with Autism Spectrum Disorder. PLoS One 2019;14:e0213242.
Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med 2016;4:2050312116671725.
Fong DY, Chan BK, Li S, Wan CH, Kazis LE. Average and individual differences between the 12-item MOS Short-form Health Survey version 2 (SF-12 V. 2) and the veterans RAND 12-item Health Survey (VR-12) in the Chinese population. Health Qual Life Outcomes 2022;20:102.
Amonkar N, Su WC, Bhat AN, Srinivasan SM. Effects of creative movement therapies on social communication, behavioral-affective, sensorimotor, cognitive, and functional participation skills of individuals with autism spectrum disorder: a systematic review. Front Psychiatry 2021;12:722874.
Peters BC, Pan Z, Christensen H, Gabriels RL. Self-regulation mediates therapeutic horseback riding social functioning outcomes in youth with autism spectrum disorder. Front Pediatr 2022;10:884054.
Belaiba M, Laatar R, Borji R, Ben Salem A, Sahli S, Rebai H. Time Limited Benefits of Physical and Proprioceptive Training on Physical Fitness Components in Children With Autism Spectrum Disorders. Percept Mot Skills 2024;131:785-804.
Suárez-Manzano S, Ruiz-Ariza A, de Loureiro NE, Martínez-López EJ. Effects of physical activity on cognition, behavior, and motor skills in youth with autism spectrum disorder: a systematic review of intervention studies. Behav Sci 2024;14:330.
Smith E, Constantin A, Johnson H, Brosnan M. Digitally-mediated social stories support children on the autism spectrum adapting to a change in a ‘real-world’context. J Autism Dev Disord 2021;51:514-26.
Kuhaneck H, Spitzer SL, Bodison SC. A systematic review of interventions to improve the occupation of play in children with autism. OTJR (Thorofare N J) 2020;40:83-98.
Storch EA, Schneider SC, De Nadai AS, Selles RR, McBride NM, Grebe SC, et al. A pilot study of family-based exposure-focused treatment for youth with autism spectrum disorder and anxiety. Child Psychiatry Hum Dev 2020;51:209-19.
Kersten ML, Coxon K, Lee H, Wilson NJ. Developing community mobility and driving with youth on the autism spectrum: a psychosocial perspective. Scand J Occup Ther 2021;28:91-6.
Refbacks
- There are currently no refbacks.
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.