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)

BACKGROUND: Autism spectrum disorders (ASD) have a lifelong impact on behavior, communication, cognitive function, education, physical functioning, and personal, or social life. Separate studies suggest, Therapeutic and dietary interventions are effective to some extent in managing these issues. No study integrated the nutrition and therapeutic approaches and examined the outcome on disease severity, overall health, and behavioral status in ASD. The proposed study is designed to evaluate the combined effect of regular therapy (RT) and structured diet (SD) compared to the usual diet (UD) for Adolescents with ASD. METHODS: The proposed study will be a randomized clinical trial (RCT) with the assessor, therapist, and participants blinded to group allocation. Seventy ASD children with malnutrition will be enrolled in two different facilities of the Centre for the Rehabilitation of the Paralysed (CRP) between January 2023 and June 2023. Participants will be enrolled through a hospital-based randomization process from a population-based screening dataset, and with a concealed group allocation to either RT+ SD or RT+ UD group with a 1:1 ratio. The outcome measures are the Childhood Autism Rating Scale as per DSM‐5 to determine the severity of ASD, Mid-upper arm circumference (MUAC), and BMI for nutritional status, and Gilliam Autism Rating Scale (GARS-2) to assess the behavioral status. Post-test will be performed after 12 weeks of intervention, and Follow-up will be taken after 6 months of post-test. PERSPECTIVES: The result of the study will contribute to the provision of a comprehensive approach to malnourished Adolescents with ASD, and manage the issues related to the severity of ASD, stereotypical behavior, and anticipated health hazards. CLINICAL TRIAL IDENTIFIER: CTRI/2022/11/047653.