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DINO RCT - Treating Anxiety in Children With Autism

Treating Anxiety in Young Children With Autism

Who can join

Ages 4 to 6 · All sexes · Healthy volunteers welcome

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)

About the study

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.

What is being tested

• DINOSAUR (behavioral)
• Psychoeducation (other)

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Participants: 70 · Started: Jan 2, 2024

Contact the study team

• Belina Onomake · Phone: 667-205-4036
• Amy Keefer, PhD · Phone: 443-923-7603

Official record on ClinicalTrials.gov — NCT06066983

Locations in the U.S.

Conditions

• Autism Spectrum Disorder
• Anxiety

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.