DINO RCT - Treating Anxiety in Children With Autism

Anxiety is prevalent in young children, under 7 years of age, with autism. Yet, few studies have examined anxiety interventions for this age range, and only one anxiety treatment study has included young children with cognitive and language delays. Anxiety treatment models utilizing cognitive-behavioral therapy (CBT), adapted for children with autism, are empirically supported in school-age autistic children. Further, preliminary evidence suggests CBT approaches may reduce intolerance of uncertainty (IU), a mechanistic construct that may contribute to the maintenance of anxiety in autistic children. This study seeks to address the existing gap in anxiety treatment by examining the feasibility and preliminary efficacy of a novel, telehealth CBT intervention, DINO Strategies for Anxiety and intolerance of Uncertainty Reduction (DINOSAUR), which targets both anxiety and IU in young autistic children.

NCT Number	NCT06066983
Lead Sponsor	Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Conditions	Autism Spectrum Disorder, Anxiety Disorders
Enrollment	70 participants
Start Date	2024-01-02
Primary Completion	2026-10-15 (estimated)
Study Completion	2026-10-15 (estimated)
Updated on ClinicalTrials.gov	2026-04-23