There is an increasing interest in using magnetic resonance imaging (MRI) as a tool for precision medicine in autism spectrum disorder (ASD). This study investigated the feasibility of MRI scanning in a large comprehensive, inclusive and test heavy clinical trial for children (aged 3-12 years) with ASD, without functioning constraints for…

Data unavailability impedes research transparency and is a major problem for individual participant data (IPD) meta-analyses as it reduces statistical power, increases risk of bias, and may even preclude completion. The primary objectives of this study were to determine IPD sharing plans reported in recently registered clinical trial registration…

Purpose: In a companion paper, we found no statistical reason to favor percentage syllables stuttered (%SS) over parent-reported stuttering severity as a primary outcome measure for clinical trials of early stuttering. Hence, considering the logistical advantages of the latter measure, we recommended parent-reported stuttering severity for use as…

A multi-centre clinical trial involves the implementation of the same clinical protocol at several independent investigational centres. Multi-centre clinical trials may be preferable to single-centre trials, but their implementation and management is more complex. EU-funded collaborative projects involve several participating organizations and…

A substantial proportion of trial registrations are not linked to corresponding published articles, limiting analyses and new tools. Our aim was to develop a method for finding articles reporting the results of trials that are registered on ClinicalTrials.gov when they do not include metadata links. We used a set of 27,280 trial registration and…

Prospective registration of study protocols in clinical trial registries is a useful way to minimize the risk of publication bias in meta-analysis, and several clinical trial registries are available nowadays. However, they are mainly used as a tool for searching studies and information submitted to the registries has not been utilized as…

Preregistration involves researchers publicly registering key study elements before conducting a study to increase the transparency of research and limit the use and impact of questionable research practices. To support special education researchers' engagement with preregistrations, in this article we provide an overview of preregistration and…

When COVID-19 disrupted autism spectrum disorder research globally, many clinical trials of behavioral interventions pivoted to telehealth. Telehealth has the potential to increase geographic reach and improve racial/ethnic diversity in research. This matters because most autism spectrum disorder intervention studies have primarily included White,…

Autistic adults report high stress and impaired ability to cope with stressors. Mindfulness-based stress reduction targets individual's own resources to regulate stress responses. An open feasibility study was conducted in an outpatient context, recruiting autistic adults without intellectual disability. The intervention, guided by trained…

Background: People with Down syndrome often present with balance deficits, which compromise safety during daily activity. While evidence shows that exercise can improve balance in the Down syndrome population, it is unclear if a telehealth method will elicit similar benefits. We aimed to examine the effects of a virtual exercise program on balance…

Although informed consent is critical for all research, there is increased ethical responsibility as individuals with intellectual or developmental disabilities (IDD) become the focus of more clinical trials. This study examined decisional capacity for informed consent to clinical trials in individuals with fragile X syndrome (FXS). Participants…

Background: The Rotterdam Evaluation Study of Stuttering Therapy randomized trial (RESTART) was seminal, comparing the Lidcombe Program with RESTART Demands and Capacities Model-based treatment (RESTART-DCM) for pre-school age children who stutter. Aims: To critique the methods of the RESTART trial to develop guidelines for its systematic…

This paper addresses psychological factors that might interfere with informed consent on the part of stable patients as potential early-phase clinical trial participants. Thirty-six semistructured interviews with patients who had either diabetes or gout were conducted. We investigated stable patients' attitudes towards participating in a…

This triple-arm, double-blind, randomized clinical trial investigated the effect of multisession prefrontal transcranial direct current stimulation (tDCS) on social functioning in individuals with autism spectrum disorder (ASD). A total of 105 individuals (age 14-21 years) diagnosed with ASD were randomized into the active-tDCS, sham-tDCS, and…

Purpose: This study was designed to answer three questions: (a) Does percentage of syllables stuttered (%SS) differ between standard and challenge phone calls; (b) Does anxiety differ between standard and challenge phone calls; and (c) Is there a relationship between %SS and anxiety during standard and challenge phone calls? Method: Participants…