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DINO RCT - Treating Anxiety in Children With Autism

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 23, 2026 (before its estimated October 15, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv7
  2. Publications: details revised at 2 of 2 entriesv6
  3. Site contact updated
    • Publications: details revised at 2 of 2 entries
    v5
  4. Start date changed from estimate of Jan 2024 to Jan 2, 2024v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Nov 2023 to Jan 2024
    • Site details revised
    v3
  6. Start date: Oct 1, 2023 to Nov 2023v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06066983
Lead Sponsor Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Conditions
(from sponsor)		 Autism Spectrum Disorder, Anxiety Disorders
Related terms Anxiety Disorders, Autism Spectrum Disorder
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov