This study examined the effects of storytelling with or without contextual information on children with autism spectrum disorder (ASD) and typical development (TD) using eye-tracker. They were randomized into two groups--the stories included and did not include social contextual information respectively. Training was delivered in groups, with…

This article outlines the rationale for adopting a mixed methods approach within randomized controlled trials (RCTs) and explores challenges associated in doing so. Taking the example of the EASE Back feasibility and pilot study (Evaluating Acupuncture and Standard care for pregnant womEn with "BACK" pain: ISRCTN49955124), we detail why…

Meta-analysis is commonly used to combine results from multiple clinical trials, but traditional meta-analysis methods do not refer explicitly to a population of individuals to whom the results apply and it is not clear how to use their results to assess a treatment's effect for a population of interest. We describe recently-introduced causally…

To better prepare undergraduate students as informed citizens, they need skills to evaluate and interpret scientific data that are relevant to real world scenarios. Socioscientific issues are typically complicated or debatable issues that require individuals to evaluate their background knowledge and make decisions with respect to social and…

The objective of this study was to provide initial validity evidence for responses to the newly expanded version of the I COPPE Actions scale from adults with obesity under an exploratory latent variable approach. Longitudinal data from the 2018 Fun For Wellness Effectiveness Trial (ClinicalTrials.gov, identifier: NCT03194854) were reanalyzed in…

Education researchers have been impacted by COVID-19 as school closures interrupted ongoing education research, including clinical trials, case study and ethnographic inquiry in schools, and longitudinal studies using federal, state, or district administrative data. The recommendations we present here focus on immediate and future actions…

This double-blind, randomized controlled trial, tested fatty acid (FA) supplementation in children (ages 2- < 6 years) recently diagnosed with Autism Spectrum Disorder (ASD). Participants received daily oral FA supplement containing omega-3 and omega-6 FA, or a placebo for 90 days based on participant weight. Erythrocyte FAs and the cytokines,…

This commentary describes the transition to remote delivery of cognitive-behavioral therapy (CBT) for anxiety in children with autism spectrum disorder (ASD) who participates in a clinical trial during the COVID-19 pandemic. The effects of COVID-19 on children's anxiety and on the family functioning are discussed. Modifications to CBT necessitated…

The Good Participatory Practice (GPP) guidelines provide a framework for stakeholder engagement within clinical trials, to ensure a study's acceptability, feasibility, and improving the overall research quality; however, they have rarely been applied beyond this setting, and no literature exists on its application in adolescent research. A review…

Parents play an important role in the treatment of their children's symptoms of autism spectrum disorder (ASD); thus, developing effective, efficient, socially acceptable, and accessible procedures for training parents to implement applied-behavior-analysis (ABA) interventions is critically important. One potential approach involves delivering…

Objective: Our objective was to evaluate the efficacy of the Sitting Together and Reaching to Play (START-Play) intervention in young infants with neuromotor disorders. Method: This randomized controlled trial compared usual care-early intervention (UC-EI) with START-Play plus UC-EI. Analyses included 112 infants with motor delay (55 UC-EI, 57…

In this paper, we discuss challenges associated with implementing a policy for Ancillary Care (AC) for related and unrelated (serious) adverse events during an Ebola vaccine trial conducted in a remote area of the Democratic Republic of the Congo. Conducting clinical trials in resource-constrained settings can raise context-related challenges that…

Clinical trials must address a number of laws, regulations, and other sources of requirements when communicating privacy and confidentiality protections to potential participants. This article outlines relevant requirements from Common Rule regulations, Food and Drug Administration regulations, Health Insurance Portability and Accountability Act…

The symptoms of autism spectrum disorder are conceptualized to alter the quality of parent--children interactions, exposure to social learning exchanges, and ultimately the course of child development. There is evidence that modifying the procedures of Pivotal Response Treatment (PRT) to explicitly target social motivation enhances child…

Introduction: Registration of clinical trials has been initiated in order to assess adherence of the reported results to the original trial protocol. This study aimed to investigate the publication rates, timely dissemination of results, and the prevalence of consistency in hypothesis, sample size, and primary endpoint of Dutch…