In a commentary published online on August 19 in Trials, Sophie Molholm, Ph.D., and colleagues describe how the COVID-19 pandemic affected their ongoing randomized controlled clinical trial over a two-year period—2020 and 2021—and how their study was able to continue despite facing significant challenges.
The study, for which analyses are ongoing, is investigating whether a popular treatment for children with neurodevelopmental disorders, sensory integration therapy, strengthens daily living skills and reduces maladaptive behavior in children with autism spectrum disorder. The paper describes the adjustments that kept the trial going despite the pandemic. For example, rapidly adjusting the study protocol, recruitment strategy, and in-person assessment battery to virtual recruitment and data collection. The authors stressed the importance of maintaining open positive and frequent communications throughout the pandemic with all participating families.
Dr. Molholm is professor of pediatrics, in the Dominick P. Purpura Department of Neuroscience, and of psychiatry and behavioral sciences, and co-director of the Rose F. Kennedy Intellectual and Developmental Research Center at Einstein. Alaina Berruti, the first author, was a study coordinator in Dr. Molholm’s lab at Einstein. Elizabeth Ridgeway, O.T.D., and Catherine Sancimino, Psy.D., both in the department of pediatrics at Einstein, are also authors on this paper.
Posted on: Thursday, October 20, 2022