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The impact of COVID-19 on autism research: A cross-sectional analysis of discontinued or suspended clinical trials / Monika NEALE in Autism Research, 15-8 (August 2022)
[article]
Titre : The impact of COVID-19 on autism research: A cross-sectional analysis of discontinued or suspended clinical trials Type de document : Texte imprimé et/ou numérique Auteurs : Monika NEALE, Auteur ; Elizabeth LANDERS, Auteur ; Nicholas B. SAJJADI, Auteur ; Anya MAZUR-MOSIEWICZ, Auteur ; Micah HARTWELL, Auteur Article en page(s) : p.1560-1564 Langues : Anglais (eng) Mots-clés : Autism Spectrum Disorder/epidemiology Autistic Disorder/epidemiology covid-19 Cross-Sectional Studies Humans Pandemics Covid-19 autism clinical trials discontinuation pandemic Index. décimale : PER Périodiques Résumé : Due to uncertainties associated with the COVID-19 public health crisis, several clinical trials had to be withdrawn or postponed. Our investigation aimed to assess the rate of discontinuation of clinical trials focusing on Autism Spectrum Disorder. Of the 197 registered trials included in our systematic review, 15 (7.6%) were discontinued, with nearly half of these explicitly citing COVID-19 as their reason for discontinuation. Pharmacological trials were six times more likely to be discontinued during the pandemic than non-pharmacological studies. The difference between the likelihood of discontinuation was statistically significant (OR: 6.13; 95% CI: 1.22-30.71). There was no evidence of association between funding source and reasons for discontinuation. Limitations, along with implications for future trials are discussed. LAY SUMMARY: We investigated the impact of the COVID-19 pandemic on the discontinuation rate of autism clinical trials. We found that drug trials were six times more likely to be discontinued during the pandemic compared to behavioral, diagnostic, and nutritional trials. The overall discontinuation rate was notably lower in autism clinical trials than in other areas of medical research. We recommend an examination of the methodology of the continued autism trials to assess their applicability in other fields. En ligne : http://dx.doi.org/10.1002/aur.2764 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=483
in Autism Research > 15-8 (August 2022) . - p.1560-1564[article] The impact of COVID-19 on autism research: A cross-sectional analysis of discontinued or suspended clinical trials [Texte imprimé et/ou numérique] / Monika NEALE, Auteur ; Elizabeth LANDERS, Auteur ; Nicholas B. SAJJADI, Auteur ; Anya MAZUR-MOSIEWICZ, Auteur ; Micah HARTWELL, Auteur . - p.1560-1564.
Langues : Anglais (eng)
in Autism Research > 15-8 (August 2022) . - p.1560-1564
Mots-clés : Autism Spectrum Disorder/epidemiology Autistic Disorder/epidemiology covid-19 Cross-Sectional Studies Humans Pandemics Covid-19 autism clinical trials discontinuation pandemic Index. décimale : PER Périodiques Résumé : Due to uncertainties associated with the COVID-19 public health crisis, several clinical trials had to be withdrawn or postponed. Our investigation aimed to assess the rate of discontinuation of clinical trials focusing on Autism Spectrum Disorder. Of the 197 registered trials included in our systematic review, 15 (7.6%) were discontinued, with nearly half of these explicitly citing COVID-19 as their reason for discontinuation. Pharmacological trials were six times more likely to be discontinued during the pandemic than non-pharmacological studies. The difference between the likelihood of discontinuation was statistically significant (OR: 6.13; 95% CI: 1.22-30.71). There was no evidence of association between funding source and reasons for discontinuation. Limitations, along with implications for future trials are discussed. LAY SUMMARY: We investigated the impact of the COVID-19 pandemic on the discontinuation rate of autism clinical trials. We found that drug trials were six times more likely to be discontinued during the pandemic compared to behavioral, diagnostic, and nutritional trials. The overall discontinuation rate was notably lower in autism clinical trials than in other areas of medical research. We recommend an examination of the methodology of the continued autism trials to assess their applicability in other fields. En ligne : http://dx.doi.org/10.1002/aur.2764 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=483 Therapeutic diets and supplementation: exploring their impact on autism spectrum disorders in childhood - A narrative review of recent clinical trials / Ruzha PANCHEVA in Research in Autism Spectrum Disorders, 112 (April 2024)
[article]
Titre : Therapeutic diets and supplementation: exploring their impact on autism spectrum disorders in childhood - A narrative review of recent clinical trials Type de document : Texte imprimé et/ou numérique Auteurs : Ruzha PANCHEVA, Auteur ; Rositsa CHAMOVA, Auteur ; Dimitar MARINOV, Auteur ; Albena TONEVA, Auteur ; Mariya DZHOGOVA, Auteur ; Sevdzhihan EYUBOVA, Auteur ; Natalya USHEVA, Auteur Article en page(s) : p.102352 Langues : Anglais (eng) Mots-clés : Autism Spectrum Disorder Nutritional interventions Clinical trials Gluten-free diet Omega-3 fatty acids Vitamins Probiotics Developmental disabilities Index. décimale : PER Périodiques Résumé : Background Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by social communication deficits, restricted interests, and repetitive behaviors. Nutritional interventions have gained attention as potential therapeutic strategies for individuals with ASD. This review aims to provide a comprehensive summary of recent clinical trials investigating the effects of various nutritional interventions on ASD symptoms. Methods A systematic search was conducted in multiple databases to identify clinical trials published between 2018 and 2023. Studies focusing on children with ASD and evaluating the impact of nutritional interventions were included. The selected articles were analyzed for study design, intervention type, outcome measures, and results. Results A total of 26 studies were included in the review, covering a range of nutritional interventions including gluten-free and casein-free diets, omega-3 fatty acid supplementation, vitamin and mineral supplementation, probiotics, prebiotics, and others. The studies varied in design, sample size, and outcome measures. Overall, the findings revealed some positive effects of specific nutritional interventions on ASD symptoms, such as improvements in social responsiveness, communication, hyperactivity, and stereotypical behaviors. However, discrepancies and limitations were noted across the studies, highlighting the need for further research. Conclusion This comprehensive review provides insights into the potential therapeutic effects of nutritional interventions for individuals with ASD. While some interventions showed promising results, further research with larger sample sizes, standardized methodologies, and longer-term follow-ups is needed to establish their efficacy. Personalized approaches, considering the heterogeneity of ASD, and strategies to enhance adherence to dietary interventions are also crucial in developing effective treatment plans. Overall, nutritional interventions hold promise as adjunctive therapies for individuals with ASD, warranting continued investigation in this field of research. En ligne : https://doi.org/10.1016/j.rasd.2024.102352 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=524
in Research in Autism Spectrum Disorders > 112 (April 2024) . - p.102352[article] Therapeutic diets and supplementation: exploring their impact on autism spectrum disorders in childhood - A narrative review of recent clinical trials [Texte imprimé et/ou numérique] / Ruzha PANCHEVA, Auteur ; Rositsa CHAMOVA, Auteur ; Dimitar MARINOV, Auteur ; Albena TONEVA, Auteur ; Mariya DZHOGOVA, Auteur ; Sevdzhihan EYUBOVA, Auteur ; Natalya USHEVA, Auteur . - p.102352.
Langues : Anglais (eng)
in Research in Autism Spectrum Disorders > 112 (April 2024) . - p.102352
Mots-clés : Autism Spectrum Disorder Nutritional interventions Clinical trials Gluten-free diet Omega-3 fatty acids Vitamins Probiotics Developmental disabilities Index. décimale : PER Périodiques Résumé : Background Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by social communication deficits, restricted interests, and repetitive behaviors. Nutritional interventions have gained attention as potential therapeutic strategies for individuals with ASD. This review aims to provide a comprehensive summary of recent clinical trials investigating the effects of various nutritional interventions on ASD symptoms. Methods A systematic search was conducted in multiple databases to identify clinical trials published between 2018 and 2023. Studies focusing on children with ASD and evaluating the impact of nutritional interventions were included. The selected articles were analyzed for study design, intervention type, outcome measures, and results. Results A total of 26 studies were included in the review, covering a range of nutritional interventions including gluten-free and casein-free diets, omega-3 fatty acid supplementation, vitamin and mineral supplementation, probiotics, prebiotics, and others. The studies varied in design, sample size, and outcome measures. Overall, the findings revealed some positive effects of specific nutritional interventions on ASD symptoms, such as improvements in social responsiveness, communication, hyperactivity, and stereotypical behaviors. However, discrepancies and limitations were noted across the studies, highlighting the need for further research. Conclusion This comprehensive review provides insights into the potential therapeutic effects of nutritional interventions for individuals with ASD. While some interventions showed promising results, further research with larger sample sizes, standardized methodologies, and longer-term follow-ups is needed to establish their efficacy. Personalized approaches, considering the heterogeneity of ASD, and strategies to enhance adherence to dietary interventions are also crucial in developing effective treatment plans. Overall, nutritional interventions hold promise as adjunctive therapies for individuals with ASD, warranting continued investigation in this field of research. En ligne : https://doi.org/10.1016/j.rasd.2024.102352 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=524 Updated report on tools to measure outcomes of clinical trials in fragile X syndrome / Dejan B. BUDIMIROVIC in Journal of Neurodevelopmental Disorders, 9-1 (December 2017)
[article]
Titre : Updated report on tools to measure outcomes of clinical trials in fragile X syndrome Type de document : Texte imprimé et/ou numérique Auteurs : Dejan B. BUDIMIROVIC, Auteur ; Elizabeth BERRY-KRAVIS, Auteur ; C. A. ERICKSON, Auteur ; S. S. HALL, Auteur ; D. HESSL, Auteur ; A. L. REISS, Auteur ; M. K. KING, Auteur ; Leonard ABBEDUTO, Auteur ; W. E. KAUFMANN, Auteur Article en page(s) : p.14 Langues : Anglais (eng) Mots-clés : Autism spectrum disorder Clinical trials Fragile X syndrome Intellectual disability Outcome measures Index. décimale : PER Périodiques Résumé : OBJECTIVE: Fragile X syndrome (FXS) has been the neurodevelopmental disorder with the most active translation of preclinical breakthroughs into clinical trials. This process has led to a critical assessment of outcome measures, which resulted in a comprehensive review published in 2013. Nevertheless, the disappointing outcome of several recent phase III drug trials in FXS, and parallel efforts at evaluating behavioral endpoints for trials in autism spectrum disorder (ASD), has emphasized the need for re-assessing outcome measures and revising recommendations for FXS. METHODS: After performing an extensive database search (PubMed, Food and Drug Administration (FDA)/National Institutes of Health (NIH)'s www.ClinicalTrials.gov, etc.) to determine progress since 2013, members of the Working Groups who published the 2013 Report evaluated the available outcome measures for FXS and related neurodevelopmental disorders using the COSMIN grading system of levels of evidence. The latter has also been applied to a British survey of endpoints for ASD. In addition, we also generated an informal classification of outcome measures for use in FXS intervention studies as instruments appropriate to detect shorter- or longer-term changes. RESULTS: To date, a total of 22 double-blind controlled clinical trials in FXS have been identified through www.ClinicalTrials.gov and an extensive literature search. The vast majority of these FDA/NIH-registered clinical trials has been completed between 2008 and 2015 and has targeted the core excitatory/inhibitory imbalance present in FXS and other neurodevelopmental disorders. Limited data exist on reliability and validity for most tools used to measure cognitive, behavioral, and other problems in FXS in these trials and other studies. Overall, evidence for most tools supports a moderate tool quality grading. Data on sensitivity to treatment, currently under evaluation, could improve ratings for some cognitive and behavioral tools. Some progress has also been made at identifying promising biomarkers, mainly on blood-based and neurophysiological measures. CONCLUSION: Despite the tangible progress in implementing clinical trials in FXS, the increasing data on measurement properties of endpoints, and the ongoing process of new tool development, the vast majority of outcome measures are at the moderate quality level with limited information on reliability, validity, and sensitivity to treatment. This situation is not unique to FXS, since reviews of endpoints for ASD have arrived at similar conclusions. These findings, in conjunction with the predominance of parent-based measures particularly in the behavioral domain, indicate that endpoint development in FXS needs to continue with an emphasis on more objective measures (observational, direct testing, biomarkers) that reflect meaningful improvements in quality of life. A major continuous challenge is the development of measurement tools concurrently with testing drug safety and efficacy in clinical trials. En ligne : http://dx.doi.org/10.1186/s11689-017-9193-x Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=350
in Journal of Neurodevelopmental Disorders > 9-1 (December 2017) . - p.14[article] Updated report on tools to measure outcomes of clinical trials in fragile X syndrome [Texte imprimé et/ou numérique] / Dejan B. BUDIMIROVIC, Auteur ; Elizabeth BERRY-KRAVIS, Auteur ; C. A. ERICKSON, Auteur ; S. S. HALL, Auteur ; D. HESSL, Auteur ; A. L. REISS, Auteur ; M. K. KING, Auteur ; Leonard ABBEDUTO, Auteur ; W. E. KAUFMANN, Auteur . - p.14.
Langues : Anglais (eng)
in Journal of Neurodevelopmental Disorders > 9-1 (December 2017) . - p.14
Mots-clés : Autism spectrum disorder Clinical trials Fragile X syndrome Intellectual disability Outcome measures Index. décimale : PER Périodiques Résumé : OBJECTIVE: Fragile X syndrome (FXS) has been the neurodevelopmental disorder with the most active translation of preclinical breakthroughs into clinical trials. This process has led to a critical assessment of outcome measures, which resulted in a comprehensive review published in 2013. Nevertheless, the disappointing outcome of several recent phase III drug trials in FXS, and parallel efforts at evaluating behavioral endpoints for trials in autism spectrum disorder (ASD), has emphasized the need for re-assessing outcome measures and revising recommendations for FXS. METHODS: After performing an extensive database search (PubMed, Food and Drug Administration (FDA)/National Institutes of Health (NIH)'s www.ClinicalTrials.gov, etc.) to determine progress since 2013, members of the Working Groups who published the 2013 Report evaluated the available outcome measures for FXS and related neurodevelopmental disorders using the COSMIN grading system of levels of evidence. The latter has also been applied to a British survey of endpoints for ASD. In addition, we also generated an informal classification of outcome measures for use in FXS intervention studies as instruments appropriate to detect shorter- or longer-term changes. RESULTS: To date, a total of 22 double-blind controlled clinical trials in FXS have been identified through www.ClinicalTrials.gov and an extensive literature search. The vast majority of these FDA/NIH-registered clinical trials has been completed between 2008 and 2015 and has targeted the core excitatory/inhibitory imbalance present in FXS and other neurodevelopmental disorders. Limited data exist on reliability and validity for most tools used to measure cognitive, behavioral, and other problems in FXS in these trials and other studies. Overall, evidence for most tools supports a moderate tool quality grading. Data on sensitivity to treatment, currently under evaluation, could improve ratings for some cognitive and behavioral tools. Some progress has also been made at identifying promising biomarkers, mainly on blood-based and neurophysiological measures. CONCLUSION: Despite the tangible progress in implementing clinical trials in FXS, the increasing data on measurement properties of endpoints, and the ongoing process of new tool development, the vast majority of outcome measures are at the moderate quality level with limited information on reliability, validity, and sensitivity to treatment. This situation is not unique to FXS, since reviews of endpoints for ASD have arrived at similar conclusions. These findings, in conjunction with the predominance of parent-based measures particularly in the behavioral domain, indicate that endpoint development in FXS needs to continue with an emphasis on more objective measures (observational, direct testing, biomarkers) that reflect meaningful improvements in quality of life. A major continuous challenge is the development of measurement tools concurrently with testing drug safety and efficacy in clinical trials. En ligne : http://dx.doi.org/10.1186/s11689-017-9193-x Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=350 Cell therapy approaches to autism: a review of clinical trial data / Jack PRICE in Molecular Autism, 11 (2020)
[article]
Titre : Cell therapy approaches to autism: a review of clinical trial data Type de document : Texte imprimé et/ou numérique Auteurs : Jack PRICE, Auteur Article en page(s) : 37 p. Langues : Anglais (eng) Mots-clés : Autism Cell therapy Clinical trials Stem cells Index. décimale : PER Périodiques Résumé : A number of clinical trials of cell therapies for autism spectrum disorder have been conducted, and some have published their outcomes. This review considers the data that have emerged from this small set of published trials, evaluates their success, and proposes further steps that could be taken if this field of endeavour is to be pursued further. A number of reservations arise from this tranche of studies, specifically the absence of identified therapeutic targets, and deficiencies in the therapeutic approach that is being employed. If this therapeutic direction is to be pursued further, then additional pre-clinical studies are recommended that might lead to improvements in patient stratification, biomarkers, the defined mode of action, and the preparation and identification of the therapeutic cells themselves. En ligne : http://dx.doi.org/10.1186/s13229-020-00348-z Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=427
in Molecular Autism > 11 (2020) . - 37 p.[article] Cell therapy approaches to autism: a review of clinical trial data [Texte imprimé et/ou numérique] / Jack PRICE, Auteur . - 37 p.
Langues : Anglais (eng)
in Molecular Autism > 11 (2020) . - 37 p.
Mots-clés : Autism Cell therapy Clinical trials Stem cells Index. décimale : PER Périodiques Résumé : A number of clinical trials of cell therapies for autism spectrum disorder have been conducted, and some have published their outcomes. This review considers the data that have emerged from this small set of published trials, evaluates their success, and proposes further steps that could be taken if this field of endeavour is to be pursued further. A number of reservations arise from this tranche of studies, specifically the absence of identified therapeutic targets, and deficiencies in the therapeutic approach that is being employed. If this therapeutic direction is to be pursued further, then additional pre-clinical studies are recommended that might lead to improvements in patient stratification, biomarkers, the defined mode of action, and the preparation and identification of the therapeutic cells themselves. En ligne : http://dx.doi.org/10.1186/s13229-020-00348-z Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=427 Editorial: Trials and tribulations in child psychology and psychiatry: what is needed for evidence-based practice / Argyris STRINGARIS in Journal of Child Psychology and Psychiatry, 55-11 (November 2014)
[article]
Titre : Editorial: Trials and tribulations in child psychology and psychiatry: what is needed for evidence-based practice Type de document : Texte imprimé et/ou numérique Auteurs : Argyris STRINGARIS, Auteur Article en page(s) : p.1185-1186 Langues : Anglais (eng) Mots-clés : Clinical trials child and adolescent psychiatry Index. décimale : PER Périodiques Résumé : If your child had leukaemia you would be distraught. Yet, there would also be hope. Most children with a diagnosis of leukaemia start their treatment as part of ongoing trials. The clinical teams looking after such children are motivated, knowledgeable and work in centres that specialise in the treatment of this lethal illness. The results speak for themselves. Not only have the trials helped oncologists learn more about which treatments work best. For years we have known that those who enter trials do better than those patients with similar characteristics who don't. We have recently also learnt that trials improve survival rates in those cancers population wide: the annual reduction between 1978–2005 in risk of death from childhood cancers ranged from 2.7% to 12.0%. This cancer trial culture is a splendid example of British health care delivery. What is happening in child psychiatry, though? If your child had, say, depression you would have every reason to be distraught too. The mortality rate is higher than in the general population and the burden of disease in the long run heavier than that of cardiovascular illness or cancer. Yet, your child would not have access to a trial. Instead, you would probably struggle to have your child's depression recognised in the first place. The care you would get would be determined by extreme regional variations and by what resources are available to local services and often the ideology or preferences of practitioners. En ligne : http://dx.doi.org/10.1111/jcpp.12343 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=241
in Journal of Child Psychology and Psychiatry > 55-11 (November 2014) . - p.1185-1186[article] Editorial: Trials and tribulations in child psychology and psychiatry: what is needed for evidence-based practice [Texte imprimé et/ou numérique] / Argyris STRINGARIS, Auteur . - p.1185-1186.
Langues : Anglais (eng)
in Journal of Child Psychology and Psychiatry > 55-11 (November 2014) . - p.1185-1186
Mots-clés : Clinical trials child and adolescent psychiatry Index. décimale : PER Périodiques Résumé : If your child had leukaemia you would be distraught. Yet, there would also be hope. Most children with a diagnosis of leukaemia start their treatment as part of ongoing trials. The clinical teams looking after such children are motivated, knowledgeable and work in centres that specialise in the treatment of this lethal illness. The results speak for themselves. Not only have the trials helped oncologists learn more about which treatments work best. For years we have known that those who enter trials do better than those patients with similar characteristics who don't. We have recently also learnt that trials improve survival rates in those cancers population wide: the annual reduction between 1978–2005 in risk of death from childhood cancers ranged from 2.7% to 12.0%. This cancer trial culture is a splendid example of British health care delivery. What is happening in child psychiatry, though? If your child had, say, depression you would have every reason to be distraught too. The mortality rate is higher than in the general population and the burden of disease in the long run heavier than that of cardiovascular illness or cancer. Yet, your child would not have access to a trial. Instead, you would probably struggle to have your child's depression recognised in the first place. The care you would get would be determined by extreme regional variations and by what resources are available to local services and often the ideology or preferences of practitioners. En ligne : http://dx.doi.org/10.1111/jcpp.12343 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=241 Clinical Validation of the Autism Behavior Inventory: Caregiver-Rated Assessment of Core and Associated Symptoms of Autism Spectrum Disorder / Abigail BANGERTER in Journal of Autism and Developmental Disorders, 50-6 (June 2020)
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