Abstract
Here we report the results of the subgroup analyses of an observational cohort of children whose parents completed the Autism Treatment Evaluation Checklist (ATEC) over the period of several years. A linear mixed effects model was used to evaluate longitudinal changes in ATEC scores within different patient subgroups. All groups decreased their mean ATEC score over time indicating improvement of symptoms, however there were significant differences between the groups. Younger children improved more than the older children. Children with milder ASD improved more than children with more severe ASD in the Communication subscale. There was no difference in improvement between females vs. males. One surprising finding was that children from developed English-speaking countries improved less than children from non-English-speaking countries.
Highlights
Design considerations for an Autism Spectrum Disorder (ASD) early-intervention clinical trial must take into account (1) the trial duration, (2) number of participants, and (3) the quality of participant assessment
The goal of the study was to characterize the typical changes in Autism Treatment Evaluation Checklist (ATEC) score over time as a function of children age, sex, ASD severity, and country of origin in a large and diverse group of participants
Charman et al utilized ATEC amongst other measures to test the feasibility of tracking the longitudinal changes in children using caregiver-administered questionnaires and noted differential effects across subscales of ATEC, possibly driven by development-focused vs. symptom-focused subscales that are conflated in the ATEC total score (Charman et al 2004)
Summary
Design considerations for an ASD early-intervention clinical trial must take into account (1) the trial duration, (2) number of participants, and (3) the quality of participant assessment. A short clinical trial of an early therapeutic intervention in 2–3 year old children can miss a target, as an improvement of symptoms may not emerge until children reach the school age. Increasing the trial duration and the number of trial participants, raises the demand for regular assessment. To attain the larger number of trial participants, clinical trials must accept participants across a large geographical region. Large numbers of ASD clinical trials working under a limited budget suffer from short duration and low participant number, often compromising the trial objectives (e.g., Drew et al 2002; Whitehouse et al 2017)
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