DINO RCT - Treating Anxiety in Children With Autism

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study ID
NCT06066983
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 6 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 2, 2024
Status verified
Apr 2026
Primary completion
Oct 15, 2026
Completion
Oct 15, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Parent-child dyads will receive DINOSAUR, a group-based cognitive-behavioral therapy (CBT) intervention, adapted for young children and delivered via telehealth. This 14 week intervention teaches parents and children strategies to reduce anxiety and intolerance of uncertainty, an underlying construct of anxiety.
  • Active Comparator: Active Control
    Parents in the active control condition will participate in three psychoeducational groups focused on presenting information regarding anxiety prevalence, differentiating anxiety from autism, and anxiety triggers. These groups will be delivered via telehealth across a 14-week period.

Primary Outcome Measure

Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA) [ Time Frame: Before and after 14-week treatment (baseline to post-treatment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kennedy Krieger InstituteBaltimoreMaryland21211
Belina Onomake
[email protected]
667-205-4036
Amy Keefer, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Kennedy Krieger Institute· Baltimore, MD

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