Concomitant medication use in children with autism spectrum disorder: Data from the Autism Biomarkers Consortium for Clinical Trials / Logan SHURTZ in Autism, 27-4 (May 2023)  

Public ISBD [article]  inAutism > 27-4 (May 2023) . - p.952-966 Titre : Concomitant medication use in children with autism spectrum disorder: Data from the Autism Biomarkers Consortium for Clinical Trials Type de document : texte imprimé Auteurs : Logan SHURTZ, Auteur ; Chloe SCHWARTZ, Auteur ; Charlotte DISTEFANO, Auteur ; James C. MCPARTLAND, Auteur ; April R. LEVIN, Auteur ; Geraldine DAWSON, Auteur ; Natalia M. KLEINHANS, Auteur ; Susan FAJA, Auteur ; Sara J. WEBB, Auteur ; Frederick SHIC, Auteur ; Adam J. NAPLES, Auteur ; Helen SEOW, Auteur ; Raphael A. BERNIER, Auteur ; Katarzyna CHAWARSKA, Auteur ; Catherine A. SUGAR, Auteur ; James DZIURA, Auteur ; Damla SENTURK, Auteur ; Megha SANTHOSH, Auteur ; Shafali S. JESTE, Auteur Article en page(s) : p.952-966 Langues : Anglais (eng) Mots-clés : aberrant behavior checklist,antipsychotics,autism spectrum disorders,clinical trials,medications,Vineland Adaptive Behavior Scales Index. décimale : PER Périodiques Résumé : Children with autism spectrum disorder are prescribed various medications to address behavior and mood. In clinical trials, individuals taking concomitant psychotropic medications often are excluded to maintain homogeneity and prevent contamination of clinical endpoints. However, this choice may compromise the representativeness of the sample. In a recent study designed to identify biomarkers and endpoints for clinical trials (the Autism Biomarkers Consortium for Clinical Trials), school-age children with autism spectrum disorder were enrolled without excluding for medications, providing the opportunity to examine characteristics of psychotropic medication use and guide future decisions on medication-related inclusion criteria. The aims of the current analysis were (1) to quantify the frequency and type of psychotropic medications reported in school-age children enrolled in the study and (2) to examine behavioral features of children with autism spectrum disorder based on medication classes. Of the 280 children with autism spectrum disorder in the cohort, 42.5% were taking psychotropic medications, with polypharmacy in half. The most commonly reported psychotropic medications included melatonin, stimulants, selective serotonin reuptake inhibitors, alpha agonists, and antipsychotics. Our findings suggest that exclusion of children taking concomitant psychotropic medications could limit the representativeness of the study population, perhaps even excluding children who may most benefit from new treatment options.Lay abstractChildren with autism spectrum disorder are prescribed a variety of medications that affect the central nervous system (psychotropic medications) to address behavior and mood. In clinical trials, individuals taking concomitant psychotropic medications often are excluded to maintain homogeneity of the sample and prevent contamination of biomarkers or clinical endpoints. However, this choice may significantly diminish the clinical representativeness of the sample. In a recent multisite study designed to identify biomarkers and behavioral endpoints for clinical trials (the Autism Biomarkers Consortium for Clinical Trials), school-age children with autism spectrum disorder were enrolled without excluding for medications, thus providing a unique opportunity to examine characteristics of psychotropic medication use in a research cohort and to guide future decisions on medication-related inclusion criteria. The aims of the current analysis were (1) to quantify the frequency and type of psychotropic medications reported in school-age children enrolled in the ABC-CT and (2) to examine behavioral features of children with autism spectrum disorder based on medication classes. Of the 280 children with autism spectrum disorder in the cohort, 42.5% were taking psychotropic medications, with polypharmacy in half of these children. The most commonly reported psychotropic medications included melatonin, stimulants, selective serotonin reuptake inhibitors, alpha agonists, and antipsychotics. Descriptive analysis showed that children taking antipsychotics displayed a trend toward greater overall impairment. Our findings suggest that exclusion of children taking concomitant psychotropic medications in trials could limit the clinical representativeness of the study population, perhaps even excluding children who may most benefit from new treatment options. En ligne : https://doi.org/10.1177/13623613221121425 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=499 [article] Concomitant medication use in children with autism spectrum disorder: Data from the Autism Biomarkers Consortium for Clinical Trials [texte imprimé] / Logan SHURTZ, Auteur ; Chloe SCHWARTZ, Auteur ; Charlotte DISTEFANO, Auteur ; James C. MCPARTLAND, Auteur ; April R. LEVIN, Auteur ; Geraldine DAWSON, Auteur ; Natalia M. KLEINHANS, Auteur ; Susan FAJA, Auteur ; Sara J. WEBB, Auteur ; Frederick SHIC, Auteur ; Adam J. NAPLES, Auteur ; Helen SEOW, Auteur ; Raphael A. BERNIER, Auteur ; Katarzyna CHAWARSKA, Auteur ; Catherine A. SUGAR, Auteur ; James DZIURA, Auteur ; Damla SENTURK, Auteur ; Megha SANTHOSH, Auteur ; Shafali S. JESTE, Auteur . - p.952-966. Langues : Anglais (eng) in Autism > 27-4 (May 2023) . - p.952-966 Mots-clés : aberrant behavior checklist,antipsychotics,autism spectrum disorders,clinical trials,medications,Vineland Adaptive Behavior Scales Index. décimale : PER Périodiques Résumé : Children with autism spectrum disorder are prescribed various medications to address behavior and mood. In clinical trials, individuals taking concomitant psychotropic medications often are excluded to maintain homogeneity and prevent contamination of clinical endpoints. However, this choice may compromise the representativeness of the sample. In a recent study designed to identify biomarkers and endpoints for clinical trials (the Autism Biomarkers Consortium for Clinical Trials), school-age children with autism spectrum disorder were enrolled without excluding for medications, providing the opportunity to examine characteristics of psychotropic medication use and guide future decisions on medication-related inclusion criteria. The aims of the current analysis were (1) to quantify the frequency and type of psychotropic medications reported in school-age children enrolled in the study and (2) to examine behavioral features of children with autism spectrum disorder based on medication classes. Of the 280 children with autism spectrum disorder in the cohort, 42.5% were taking psychotropic medications, with polypharmacy in half. The most commonly reported psychotropic medications included melatonin, stimulants, selective serotonin reuptake inhibitors, alpha agonists, and antipsychotics. Our findings suggest that exclusion of children taking concomitant psychotropic medications could limit the representativeness of the study population, perhaps even excluding children who may most benefit from new treatment options.Lay abstractChildren with autism spectrum disorder are prescribed a variety of medications that affect the central nervous system (psychotropic medications) to address behavior and mood. In clinical trials, individuals taking concomitant psychotropic medications often are excluded to maintain homogeneity of the sample and prevent contamination of biomarkers or clinical endpoints. However, this choice may significantly diminish the clinical representativeness of the sample. In a recent multisite study designed to identify biomarkers and behavioral endpoints for clinical trials (the Autism Biomarkers Consortium for Clinical Trials), school-age children with autism spectrum disorder were enrolled without excluding for medications, thus providing a unique opportunity to examine characteristics of psychotropic medication use in a research cohort and to guide future decisions on medication-related inclusion criteria. The aims of the current analysis were (1) to quantify the frequency and type of psychotropic medications reported in school-age children enrolled in the ABC-CT and (2) to examine behavioral features of children with autism spectrum disorder based on medication classes. Of the 280 children with autism spectrum disorder in the cohort, 42.5% were taking psychotropic medications, with polypharmacy in half of these children. The most commonly reported psychotropic medications included melatonin, stimulants, selective serotonin reuptake inhibitors, alpha agonists, and antipsychotics. Descriptive analysis showed that children taking antipsychotics displayed a trend toward greater overall impairment. Our findings suggest that exclusion of children taking concomitant psychotropic medications in trials could limit the clinical representativeness of the study population, perhaps even excluding children who may most benefit from new treatment options. En ligne : https://doi.org/10.1177/13623613221121425 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=499

Enhancing Low-Intensity Coaching in Parent Implemented Early Start Denver Model Intervention for Early Autism: A Randomized Comparison Treatment Trial / Sally J. ROGERS in Journal of Autism and Developmental Disorders, 49-2 (February 2019)  

Public ISBD [article]  inJournal of Autism and Developmental Disorders > 49-2 (February 2019) . - p.632-646 Titre : Enhancing Low-Intensity Coaching in Parent Implemented Early Start Denver Model Intervention for Early Autism: A Randomized Comparison Treatment Trial Type de document : texte imprimé Auteurs : Sally J. ROGERS, Auteur ; Annette ESTES, Auteur ; Laura VISMARA, Auteur ; Jeffrey MUNSON, Auteur ; C. ZIERHUT, Auteur ; Jessica GREENSON, Auteur ; Geraldine DAWSON, Auteur ; Marie ROCHA, Auteur ; Catherine SUGAR, Auteur ; Damla SENTURK, Auteur ; F. WHELAN, Auteur ; M. TALBOTT, Auteur Article en page(s) : p.632-646 Langues : Anglais (eng) Mots-clés : Autism  Esdm  Early intervention  Parent-implemented intervention  Toddlers Index. décimale : PER Périodiques Résumé : Short-term low intensity parent implemented intervention studies for toddlers with autism spectrum disorder (ASD) have found it difficult to demonstrate significantly improved developmental scores or autism severity compared to community treatment. We conducted a randomized comparative intent-to-treat study of a parent implemented intervention to (1) test the effects of an enhanced version on parent and child learning, and (2) evaluate the sensitivity to change of proximal versus distal measures of child behavior. We randomized 45 children with ASD, 12-30 months of age, into one of two versions of parent-implemented Early Start Denver Model (P-ESDM), the basic model, in which we delivered 1.5 h of clinic-based parent coaching weekly, and an enhanced version that contained three additions: motivational interviewing, multimodal learning tools, and a weekly 1.5-h home visit. We delivered the intervention for 12 weeks and measured child and parent change frequently in multiple settings. We found a time-by-group interaction: parents in the enhanced group demonstrated significantly greater gains in interaction skills than did parents in the non-enhanced group. Both interventions were associated with significant developmental acceleration; however, child outcomes did not differ by group. We found a significant relationship between degree of change in parental interaction skill and rate of children's improvement on our proximal measure. Parents in both groups reported satisfaction with the intervention. These findings suggest that parent skills improved more in the enhanced group than the comparison group. Children in the two groups showed similar improvements. Rate of individual parent learning was associated with greater individual child progress on a measure quite proximal to the treatment, though not on standardized assessments. En ligne : http://dx.doi.org/10.1007/s10803-018-3740-5 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=382 [article] Enhancing Low-Intensity Coaching in Parent Implemented Early Start Denver Model Intervention for Early Autism: A Randomized Comparison Treatment Trial [texte imprimé] / Sally J. ROGERS, Auteur ; Annette ESTES, Auteur ; Laura VISMARA, Auteur ; Jeffrey MUNSON, Auteur ; C. ZIERHUT, Auteur ; Jessica GREENSON, Auteur ; Geraldine DAWSON, Auteur ; Marie ROCHA, Auteur ; Catherine SUGAR, Auteur ; Damla SENTURK, Auteur ; F. WHELAN, Auteur ; M. TALBOTT, Auteur . - p.632-646. Langues : Anglais (eng) in Journal of Autism and Developmental Disorders > 49-2 (February 2019) . - p.632-646 Mots-clés : Autism  Esdm  Early intervention  Parent-implemented intervention  Toddlers Index. décimale : PER Périodiques Résumé : Short-term low intensity parent implemented intervention studies for toddlers with autism spectrum disorder (ASD) have found it difficult to demonstrate significantly improved developmental scores or autism severity compared to community treatment. We conducted a randomized comparative intent-to-treat study of a parent implemented intervention to (1) test the effects of an enhanced version on parent and child learning, and (2) evaluate the sensitivity to change of proximal versus distal measures of child behavior. We randomized 45 children with ASD, 12-30 months of age, into one of two versions of parent-implemented Early Start Denver Model (P-ESDM), the basic model, in which we delivered 1.5 h of clinic-based parent coaching weekly, and an enhanced version that contained three additions: motivational interviewing, multimodal learning tools, and a weekly 1.5-h home visit. We delivered the intervention for 12 weeks and measured child and parent change frequently in multiple settings. We found a time-by-group interaction: parents in the enhanced group demonstrated significantly greater gains in interaction skills than did parents in the non-enhanced group. Both interventions were associated with significant developmental acceleration; however, child outcomes did not differ by group. We found a significant relationship between degree of change in parental interaction skill and rate of children's improvement on our proximal measure. Parents in both groups reported satisfaction with the intervention. These findings suggest that parent skills improved more in the enhanced group than the comparison group. Children in the two groups showed similar improvements. Rate of individual parent learning was associated with greater individual child progress on a measure quite proximal to the treatment, though not on standardized assessments. En ligne : http://dx.doi.org/10.1007/s10803-018-3740-5 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=382

Evaluation of clinical assessments of social abilities for use in autism clinical trials by the autism biomarkers consortium for clinical trials / Susan FAJA in Autism Research, 16-5 (May 2023)  

Public ISBD [article]  inAutism Research > 16-5 (May 2023) . - p.981-996 Titre : Evaluation of clinical assessments of social abilities for use in autism clinical trials by the autism biomarkers consortium for clinical trials Type de document : texte imprimé Auteurs : Susan FAJA, Auteur ; Maura SABATOS-DEVITO, Auteur ; Aksheya SRIDHAR, Auteur ; Jocelyn KUHN, Auteur ; Julia I. NIKOLAEVA, Auteur ; Catherine A. SUGAR, Auteur ; Sara Jane WEBB, Auteur ; Raphael A. BERNIER, Auteur ; Linmarie SIKICH, Auteur ; Gerhard HELLEMANN, Auteur ; Damla SENTURK, Auteur ; Adam J. NAPLES, Auteur ; Frederick SHIC, Auteur ; April R. LEVIN, Auteur ; Helen A. SEOW, Auteur ; James DZIURA, Auteur ; Shafali S. JESTE, Auteur ; Katarzyna CHAWARSKA, Auteur ; Charles A. NELSON, Auteur ; Geraldine DAWSON, Auteur ; James C. MCPARTLAND, Auteur ; THE AUTISM BIOMARKERS CONSORTIUM FOR CLINICAL TRIALS, Auteur Article en page(s) : p.981-996 Langues : Anglais (eng) Index. décimale : PER Périodiques Résumé : Abstract Clinical trials in autism spectrum disorder (ASD) often rely on clinician rating scales and parent surveys to measure autism-related features and social behaviors. To aid in the selection of these assessments for future clinical trials, the Autism Biomarkers Consortium for Clinical Trials (ABC-CT) directly compared eight common instruments with respect to acquisition rates, sensitivity to group differences, equivalence across demographic sub-groups, convergent validity, and stability over a 6-week period. The sample included 280 children diagnosed with ASD (65 girls) and 119 neurotypical children (36 girls) aged from 6 to 11 years. Full scale IQ for ASD ranged from 60 to 150 and for neurotypical ranged from 86 to 150. Instruments measured clinician global assessment and autism-related behaviors, social communication abilities, adaptive function, and social withdrawal behavior. For each instrument, we examined only the scales that measured social or communication functioning. Data acquisition rates were at least 97.5% at T1 and 95.7% at T2. All scales distinguished diagnostic groups. Some scales significantly differed by participant and/or family demographic characteristics. Within the ASD group, most clinical instruments exhibited weak (? |0.1|) to moderate (? |0.4|) intercorrelations. Short-term stability was moderate (ICC: 0.5-0.75) to excellent (ICC: >0.9) within the ASD group. Variations in the degree of stability may inform viability for different contexts of use, such as identifying clinical subgroups for trials versus serving as a modifiable clinical outcome. All instruments were evaluated in terms of their advantages and potential concerns for use in clinical trials. En ligne : http://dx.doi.org/https://doi.org/10.1002/aur.2905 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=503 [article] Evaluation of clinical assessments of social abilities for use in autism clinical trials by the autism biomarkers consortium for clinical trials [texte imprimé] / Susan FAJA, Auteur ; Maura SABATOS-DEVITO, Auteur ; Aksheya SRIDHAR, Auteur ; Jocelyn KUHN, Auteur ; Julia I. NIKOLAEVA, Auteur ; Catherine A. SUGAR, Auteur ; Sara Jane WEBB, Auteur ; Raphael A. BERNIER, Auteur ; Linmarie SIKICH, Auteur ; Gerhard HELLEMANN, Auteur ; Damla SENTURK, Auteur ; Adam J. NAPLES, Auteur ; Frederick SHIC, Auteur ; April R. LEVIN, Auteur ; Helen A. SEOW, Auteur ; James DZIURA, Auteur ; Shafali S. JESTE, Auteur ; Katarzyna CHAWARSKA, Auteur ; Charles A. NELSON, Auteur ; Geraldine DAWSON, Auteur ; James C. MCPARTLAND, Auteur ; THE AUTISM BIOMARKERS CONSORTIUM FOR CLINICAL TRIALS, Auteur . - p.981-996. Langues : Anglais (eng) in Autism Research > 16-5 (May 2023) . - p.981-996 Index. décimale : PER Périodiques Résumé : Abstract Clinical trials in autism spectrum disorder (ASD) often rely on clinician rating scales and parent surveys to measure autism-related features and social behaviors. To aid in the selection of these assessments for future clinical trials, the Autism Biomarkers Consortium for Clinical Trials (ABC-CT) directly compared eight common instruments with respect to acquisition rates, sensitivity to group differences, equivalence across demographic sub-groups, convergent validity, and stability over a 6-week period. The sample included 280 children diagnosed with ASD (65 girls) and 119 neurotypical children (36 girls) aged from 6 to 11 years. Full scale IQ for ASD ranged from 60 to 150 and for neurotypical ranged from 86 to 150. Instruments measured clinician global assessment and autism-related behaviors, social communication abilities, adaptive function, and social withdrawal behavior. For each instrument, we examined only the scales that measured social or communication functioning. Data acquisition rates were at least 97.5% at T1 and 95.7% at T2. All scales distinguished diagnostic groups. Some scales significantly differed by participant and/or family demographic characteristics. Within the ASD group, most clinical instruments exhibited weak (? |0.1|) to moderate (? |0.4|) intercorrelations. Short-term stability was moderate (ICC: 0.5-0.75) to excellent (ICC: >0.9) within the ASD group. Variations in the degree of stability may inform viability for different contexts of use, such as identifying clinical subgroups for trials versus serving as a modifiable clinical outcome. All instruments were evaluated in terms of their advantages and potential concerns for use in clinical trials. En ligne : http://dx.doi.org/https://doi.org/10.1002/aur.2905 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=503

A solution to limitations of cognitive testing in children with intellectual disabilities: the case of fragile X syndrome / David HESSL in Journal of Neurodevelopmental Disorders, 1-1 (March 2009)  

Public ISBD [article]  inJournal of Neurodevelopmental Disorders > 1-1 (March 2009) . - p.33-45 Titre : A solution to limitations of cognitive testing in children with intellectual disabilities: the case of fragile X syndrome Type de document : texte imprimé Auteurs : David HESSL, Auteur ; Danh V. NGUYEN, Auteur ; Cherie GREEN, Auteur ; Alyssa D. CHAVEZ, Auteur ; Flora TASSONE, Auteur ; Randi J. HAGERMAN, Auteur ; Damla SENTURK, Auteur ; Andrea SCHNEIDER, Auteur ; Amy A. LIGHTBODY, Auteur ; Allan L. REISS, Auteur ; Scott S. HALL, Auteur Article en page(s) : p.33-45 Langues : Anglais (eng) Mots-clés : Assessment  FMR1 gene  Fmrp  Iq  Mental retardation Index. décimale : PER Périodiques Résumé : Intelligence testing in children with intellectual disabilities (ID) has significant limitations. The normative samples of widely used intelligence tests, such as the Wechsler Intelligence Scales, rarely include an adequate number of subjects with ID needed to provide sensitive measurement in the very low ability range, and they are highly subject to floor effects. The IQ measurement problems in these children prevent characterization of strengths and weaknesses, poorer estimates of cognitive abilities in research applications, and in clinical settings, limited utility for assessment, prognosis estimation, and planning intervention. Here, we examined the sensitivity of the Wechsler Intelligence Scale for Children (WISC-III) in a large sample of children with fragile X syndrome (FXS), the most common cause of inherited ID. The WISC-III was administered to 217 children with FXS (age 6-17 years, 83 girls and 134 boys). Using raw norms data obtained with permission from the Psychological Corporation, we calculated normalized scores representing each participant's actual deviation from the standardization sample using a z-score transformation. To validate this approach, we compared correlations between the new normalized scores versus the usual standard scores with a measure of adaptive behavior (Vineland Adaptive Behavior Scales) and with a genetic measure specific to FXS (FMR1 protein or FMRP). The distribution of WISC-III standard scores showed significant skewing with floor effects in a high proportion of participants, especially males (64.9%-94.0% across subtests). With the z-score normalization, the flooring problems were eliminated and scores were normally distributed. Furthermore, we found correlations between cognitive performance and adaptive behavior, and between cognition and FMRP that were very much improved when using these normalized scores in contrast to the usual standardized scores. The results of this study show that meaningful variation in intellectual ability in children with FXS, and probably other populations of children with neurodevelopmental disorders, is obscured by the usual translation of raw scores into standardized scores. A method of raw score transformation may improve the characterization of cognitive functioning in ID populations, especially for research applications. En ligne : http://dx.doi.org/10.1007/s11689-008-9001-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=341 [article] A solution to limitations of cognitive testing in children with intellectual disabilities: the case of fragile X syndrome [texte imprimé] / David HESSL, Auteur ; Danh V. NGUYEN, Auteur ; Cherie GREEN, Auteur ; Alyssa D. CHAVEZ, Auteur ; Flora TASSONE, Auteur ; Randi J. HAGERMAN, Auteur ; Damla SENTURK, Auteur ; Andrea SCHNEIDER, Auteur ; Amy A. LIGHTBODY, Auteur ; Allan L. REISS, Auteur ; Scott S. HALL, Auteur . - p.33-45. Langues : Anglais (eng) in Journal of Neurodevelopmental Disorders > 1-1 (March 2009) . - p.33-45 Mots-clés : Assessment  FMR1 gene  Fmrp  Iq  Mental retardation Index. décimale : PER Périodiques Résumé : Intelligence testing in children with intellectual disabilities (ID) has significant limitations. The normative samples of widely used intelligence tests, such as the Wechsler Intelligence Scales, rarely include an adequate number of subjects with ID needed to provide sensitive measurement in the very low ability range, and they are highly subject to floor effects. The IQ measurement problems in these children prevent characterization of strengths and weaknesses, poorer estimates of cognitive abilities in research applications, and in clinical settings, limited utility for assessment, prognosis estimation, and planning intervention. Here, we examined the sensitivity of the Wechsler Intelligence Scale for Children (WISC-III) in a large sample of children with fragile X syndrome (FXS), the most common cause of inherited ID. The WISC-III was administered to 217 children with FXS (age 6-17 years, 83 girls and 134 boys). Using raw norms data obtained with permission from the Psychological Corporation, we calculated normalized scores representing each participant's actual deviation from the standardization sample using a z-score transformation. To validate this approach, we compared correlations between the new normalized scores versus the usual standard scores with a measure of adaptive behavior (Vineland Adaptive Behavior Scales) and with a genetic measure specific to FXS (FMR1 protein or FMRP). The distribution of WISC-III standard scores showed significant skewing with floor effects in a high proportion of participants, especially males (64.9%-94.0% across subtests). With the z-score normalization, the flooring problems were eliminated and scores were normally distributed. Furthermore, we found correlations between cognitive performance and adaptive behavior, and between cognition and FMRP that were very much improved when using these normalized scores in contrast to the usual standardized scores. The results of this study show that meaningful variation in intellectual ability in children with FXS, and probably other populations of children with neurodevelopmental disorders, is obscured by the usual translation of raw scores into standardized scores. A method of raw score transformation may improve the characterization of cognitive functioning in ID populations, especially for research applications. En ligne : http://dx.doi.org/10.1007/s11689-008-9001-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=341

The autism biomarkers consortium for clinical trials: evaluation of a battery of candidate eye-tracking biomarkers for use in autism clinical trials / Frederick SHIC in Molecular Autism, 13 (2022)  

Public ISBD [article]  inMolecular Autism > 13 (2022) . - 15 p. Titre : The autism biomarkers consortium for clinical trials: evaluation of a battery of candidate eye-tracking biomarkers for use in autism clinical trials Type de document : texte imprimé Auteurs : Frederick SHIC, Auteur ; Adam J. NAPLES, Auteur ; Erin C. BARNEY, Auteur ; Shou An CHANG, Auteur ; Beibin LI, Auteur ; Takumi MCALLISTER, Auteur ; Minah KIM, Auteur ; Kelsey J. DOMMER, Auteur ; Simone HASSELMO, Auteur ; Adham ATYABI, Auteur ; Quan WANG, Auteur ; Gerhard HELLEMAN, Auteur ; April R. LEVIN, Auteur ; Helen SEOW, Auteur ; Raphael A. BERNIER, Auteur ; Katarzyna CHARWASKA, Auteur ; Geraldine DAWSON, Auteur ; James DZIURA, Auteur ; Susan FAJA, Auteur ; Shafali S. JESTE, Auteur ; Scott JOHNSON, Auteur ; Michael MURIAS, Auteur ; Charles A. NELSON, Auteur ; Maura SABATOS-DEVITO, Auteur ; Damla SENTURK, Auteur ; Catherine A. SUGAR, Auteur ; Sara J. WEBB, Auteur ; James C. MCPARTLAND, Auteur Article en page(s) : 15 p. Langues : Anglais (eng) Mots-clés : Autism Spectrum Disorder/diagnosis/psychology  Autistic Disorder/diagnosis  Biomarkers  Child  Eye Movements  Eye-Tracking Technology  Humans  Autism spectrum disorder  Biological motion  Eye tracking  Face processing  Gaze pattern  Visual attention Index. décimale : PER Périodiques Résumé : BACKGROUND: Eye tracking (ET) is a powerful methodology for studying attentional processes through quantification of eye movements. The precision, usability, and cost-effectiveness of ET render it a promising platform for developing biomarkers for use in clinical trials for autism spectrum disorder (ASD). METHODS: The autism biomarkers consortium for clinical trials conducted a multisite, observational study of 6-11-year-old children with ASD (n=280) and typical development (TD, n=119). The ET battery included: Activity Monitoring, Social Interactive, Static Social Scenes, Biological Motion Preference, and Pupillary Light Reflex tasks. A priori, gaze to faces in Activity Monitoring, Social Interactive, and Static Social Scenes tasks were aggregated into an Oculomotor Index of Gaze to Human Faces (OMI) as the primary outcome measure. This work reports on fundamental biomarker properties (data acquisition rates, construct validity, six-week stability, group discrimination, and clinical relationships) derived from these assays that serve as a base for subsequent development of clinical trial biomarker applications. RESULTS: All tasks exhibited excellent acquisition rates, met expectations for construct validity, had moderate or high six-week stabilities, and highlighted subsets of the ASD group with distinct biomarker performance. Within ASD, higher OMI was associated with increased memory for faces, decreased autism symptom severity, and higher verbal IQ and pragmatic communication skills. LIMITATIONS: No specific interventions were administered in this study, limiting information about how ET biomarkers track or predict outcomes in response to treatment. This study did not consider co-occurrence of psychiatric conditions nor specificity in comparison with non-ASD special populations, therefore limiting our understanding of the applicability of outcomes to specific clinical contexts-of-use. Research-grade protocols and equipment were used; further studies are needed to explore deployment in less standardized contexts. CONCLUSIONS: All ET tasks met expectations regarding biomarker properties, with strongest performance for tasks associated with attention to human faces and weakest performance associated with biological motion preference. Based on these data, the OMI has been accepted to the FDA's Biomarker Qualification program, providing a path for advancing efforts to develop biomarkers for use in clinical trials. En ligne : http://dx.doi.org/10.1186/s13229-021-00482-2 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=477 [article] The autism biomarkers consortium for clinical trials: evaluation of a battery of candidate eye-tracking biomarkers for use in autism clinical trials [texte imprimé] / Frederick SHIC, Auteur ; Adam J. NAPLES, Auteur ; Erin C. BARNEY, Auteur ; Shou An CHANG, Auteur ; Beibin LI, Auteur ; Takumi MCALLISTER, Auteur ; Minah KIM, Auteur ; Kelsey J. DOMMER, Auteur ; Simone HASSELMO, Auteur ; Adham ATYABI, Auteur ; Quan WANG, Auteur ; Gerhard HELLEMAN, Auteur ; April R. LEVIN, Auteur ; Helen SEOW, Auteur ; Raphael A. BERNIER, Auteur ; Katarzyna CHARWASKA, Auteur ; Geraldine DAWSON, Auteur ; James DZIURA, Auteur ; Susan FAJA, Auteur ; Shafali S. JESTE, Auteur ; Scott JOHNSON, Auteur ; Michael MURIAS, Auteur ; Charles A. NELSON, Auteur ; Maura SABATOS-DEVITO, Auteur ; Damla SENTURK, Auteur ; Catherine A. SUGAR, Auteur ; Sara J. WEBB, Auteur ; James C. MCPARTLAND, Auteur . - 15 p. Langues : Anglais (eng) in Molecular Autism > 13 (2022) . - 15 p. Mots-clés : Autism Spectrum Disorder/diagnosis/psychology  Autistic Disorder/diagnosis  Biomarkers  Child  Eye Movements  Eye-Tracking Technology  Humans  Autism spectrum disorder  Biological motion  Eye tracking  Face processing  Gaze pattern  Visual attention Index. décimale : PER Périodiques Résumé : BACKGROUND: Eye tracking (ET) is a powerful methodology for studying attentional processes through quantification of eye movements. The precision, usability, and cost-effectiveness of ET render it a promising platform for developing biomarkers for use in clinical trials for autism spectrum disorder (ASD). METHODS: The autism biomarkers consortium for clinical trials conducted a multisite, observational study of 6-11-year-old children with ASD (n=280) and typical development (TD, n=119). The ET battery included: Activity Monitoring, Social Interactive, Static Social Scenes, Biological Motion Preference, and Pupillary Light Reflex tasks. A priori, gaze to faces in Activity Monitoring, Social Interactive, and Static Social Scenes tasks were aggregated into an Oculomotor Index of Gaze to Human Faces (OMI) as the primary outcome measure. This work reports on fundamental biomarker properties (data acquisition rates, construct validity, six-week stability, group discrimination, and clinical relationships) derived from these assays that serve as a base for subsequent development of clinical trial biomarker applications. RESULTS: All tasks exhibited excellent acquisition rates, met expectations for construct validity, had moderate or high six-week stabilities, and highlighted subsets of the ASD group with distinct biomarker performance. Within ASD, higher OMI was associated with increased memory for faces, decreased autism symptom severity, and higher verbal IQ and pragmatic communication skills. LIMITATIONS: No specific interventions were administered in this study, limiting information about how ET biomarkers track or predict outcomes in response to treatment. This study did not consider co-occurrence of psychiatric conditions nor specificity in comparison with non-ASD special populations, therefore limiting our understanding of the applicability of outcomes to specific clinical contexts-of-use. Research-grade protocols and equipment were used; further studies are needed to explore deployment in less standardized contexts. CONCLUSIONS: All ET tasks met expectations regarding biomarker properties, with strongest performance for tasks associated with attention to human faces and weakest performance associated with biological motion preference. Based on these data, the OMI has been accepted to the FDA's Biomarker Qualification program, providing a path for advancing efforts to develop biomarkers for use in clinical trials. En ligne : http://dx.doi.org/10.1186/s13229-021-00482-2 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=477

The Selective Social Attention task in children with autism spectrum disorder: Results from the Autism Biomarkers Consortium for Clinical Trials (ABC-CT) feasibility study / Erin C. BARNEY ; Adam J. NAPLES ; Kelsey J. DOMMER ; Shou An CHANG ; Beibin LI ; Takumi MCALLISTER ; Adham ATYABI ; Quan WANG ; Raphael A. BERNIER ; Geraldine DAWSON ; James DZIURA ; Susan FAJA ; Shafali S. JESTE ; Michael MURIAS ; Scott JOHNSON ; Maura SABATOS-DEVITO ; Gerhard HELLEMAN ; Damla SENTURK ; Catherine A. SUGAR ; Sara Jane WEBB ; James C. MCPARTLAND ; Katarzyna CHAWARSKA ; THE AUTISM BIOMARKERS CONSORTIUM FOR CLINICAL TRIALS in Autism Research, 16-11 (November 2023)  

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