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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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10686458/ https://www.ncbi.nlm.nih.gov/pubmed/38019825 http://dx.doi.org/10.1371/journal.pone.0292326 |
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author | Akter, Ruksana Urme, Nadia Afrin Hossain, K. M. Amran Hossain, Tofajjal Ahammad, Shameem Yeasmin, Mst. Hosneara Hossain, Md. Zahid Parvin, Rashida Hossain, Md. Sohrab Zahid, Md. Ashrafuzzaman |
author_facet | Akter, Ruksana Urme, Nadia Afrin Hossain, K. M. Amran Hossain, Tofajjal Ahammad, Shameem Yeasmin, Mst. Hosneara Hossain, Md. Zahid Parvin, Rashida Hossain, Md. Sohrab Zahid, Md. Ashrafuzzaman |
author_sort | Akter, Ruksana |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10686458 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-106864582023-11-30 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) Akter, Ruksana Urme, Nadia Afrin Hossain, K. M. Amran Hossain, Tofajjal Ahammad, Shameem Yeasmin, Mst. Hosneara Hossain, Md. Zahid Parvin, Rashida Hossain, Md. Sohrab Zahid, Md. Ashrafuzzaman PLoS One Study Protocol 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. Public Library of Science 2023-11-29 /pmc/articles/PMC10686458/ /pubmed/38019825 http://dx.doi.org/10.1371/journal.pone.0292326 Text en © 2023 Akter et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Study Protocol Akter, Ruksana Urme, Nadia Afrin Hossain, K. M. Amran Hossain, Tofajjal Ahammad, Shameem Yeasmin, Mst. Hosneara Hossain, Md. Zahid Parvin, Rashida Hossain, Md. Sohrab Zahid, Md. Ashrafuzzaman 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) |
title | 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) |
title_full | 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) |
title_fullStr | 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) |
title_full_unstemmed | 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) |
title_short | 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) |
title_sort | 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) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10686458/ https://www.ncbi.nlm.nih.gov/pubmed/38019825 http://dx.doi.org/10.1371/journal.pone.0292326 |
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