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DINO RCT - Treating Anxiety in Children With Autism

Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · NCT06066983

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 4–6 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
70
US sites recruiting
1
Study start
January 2, 2024
Record last updated
April 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: DINOSAUR; Psychoeducation

Conditions: Autism Spectrum Disorder; Anxiety Disorders

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Age 4 years 0 months to 6 years 11 months
  • DSM-5 ASD diagnosis based on clinical impressions and results of the Autism Diagnostic Observation Schedule-2 (ADOS-2)
  • CBCL Anxiety Problems T-score > 65
  • SB-5 ABIQ > 60
  • Receptive and expressive language age equivalent > 36 months based on Test of Early Language Development, Fourth Edition (TELD-4)
  • Parent (or other caregiver) available and willing to attend 14-week intervention
  • Absence of identifiable neurological (e.g., epilepsy), genetic (e.g., Down syndrome, fragile X, tuberous sclerosis, neurofibromatosis) or severe sensory-motor (e.g., severe vision impairment) conditions
  • Able to walk independently (a requirement for ADOS-2)

Exclusion Criteria

  • Primary language other than English
  • Child is in foster care
  • Child displays severe behavior challenges that prevent participation in treatment groups (i.e., severe tantrums, aggression, or self-injury)
  • Participating parent experiencing active symptoms of substance abuse or severe mental illness (i.e., schizophrenia, bipolar disorder)

Recruiting US locations

  • Kennedy Krieger Institute

    Baltimore, MD 21211

    Site contact: Belina Onomake · 667-205-4036 · OnomakeB@kennedykrieger.org

Study contacts (from the official record)

  • Belina Onomake · 667-205-4036 · OnomakeB@kennedykrieger.org
  • Amy Keefer, PhD · 443-923-7603 · keefer@kennedykrieger.org
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DINO RCT - Treating Anxiety in Children With Autism (NCT06066983) | Bored Studies