A Comparison of Compensatory and Remediation Cognitive Interventions in Preschoolers With Autism: A Study Protocol for Randomized Controlled Trial

Introduction: Interventions using ‘hybrid’ remediation/compensatory cognitive interventions may be beneficial to improving the socio-cognitive functioning of children with autism spectrum disorder (ASD). Previous studies have shown that neurocognitive impairments in executive function (EF) and theory of mind (TOM) are specifically associated with ASD. The primary objective of the study is to determine the impact of the remediation and compensatory cognitive intervention on EFs and TOM abilities. The secondary objective is to evaluate TOM and EF behavioral domains due to the remediation and compensatory cognitive intervention.  Methods: A total of 75 children aged 4 to 7 years diagnosed with high-functioning autism and their parents will be recruited to this double-blind, multicenter, multi-arm randomized controlled trial. The primary outcomes are EFs and TOM as measured by the shape school, shape span test, TOM scale, TOM story books, TOM assessment checklist, and EFs assessment checklist. The secondary outcome is EFs and TOM behavioral domains as measured by the TOM behavior checklist and brief-preschool version at baseline (T0), post-test (T1), 1-month follow-up (T2), and 3-month follow-up (T3). Primary and secondary outcomes will be analyzed using repeated measures, such as an analysis of variance and a mixed model.  Conclusion: This study will assess whether the cognitive intervention program affects not only the neuropsychological functioning of children with ASD but also daily functioning. If the current trial shows that either the remediation or compensatory approaches effectively improve socio-cognitive functioning, the trial would reveal a ‘hybrid’ remediation/compensatory approach.