NCT06066983

DINO RCT - Treating Anxiety in Children With Autism

Treating Anxiety in Young Children With Autism

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Academic / Other
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The purpose of this study is to examine the feasibility and preliminary efficacy of a new treatment that targets both anxiety and IU, i.e., DINOSAUR, in young autistic children with varying cognitive and language levels. To accomplish this goal, we will investigate if DINOSAUR is a feasible intervention for families of young autistic children. We will also investigate if DINOSAUR is superior to an active control condition in reducing anxiety and IU. A third, exploratory goal is to understand how children's language and cognitive level affect their response to anxiety treatment. Seventy children, 4-6 years of age with autism and clinically significant anxiety, and their parents will be randomly assigned to receive either DINOSAUR or the active control (35 in each group) over 14 weeks via telehealth. Within each condition, children will be stratified based on cognitive level. Anxiety and IU will be assessed following treatment and at 4-month follow-up.

Conditions

• Autism Spectrum Disorder
• Anxiety Disorders

Interventions

Type	Name	Description
BEHAVIORAL	DINOSAUR	This intervention aims to treat intolerance of uncertainty and anxiety in young autistic children.
OTHER	Psychoeducation	This intervention provides psychoeducation regarding anxiety and autism.

Timeline

• Start date: 2024-01-02
• Primary completion: 2026-10-15
• Completion: 2026-10-15
• First posted: 2023-10-04
• Last updated: 2025-10-28

Locations

1 site across 1 country: United States