Status:
RECRUITING
DINO RCT - Treating Anxiety in Children With Autism
Lead Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Conditions:
Autism Spectrum Disorder
Anxiety Disorders
Eligibility:
All Genders
4-6 years
Phase:
NA
Brief 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 yo...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06066983
Start Date
January 2 2024
End Date
October 15 2026
Last Update
October 28 2025
Active Locations (1)
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1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21211