NCT06066983Recruiting
DINO RCT - Treating Anxiety in Children With Autism
Treating Anxiety in Young Children With Autism
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 28 Sept 2023
- Start date
- 2 Jan 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Diseases
- Autism
- NCT number
- NCT06066983
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 2 Jan 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participating parent experiencing active symptoms of substance abuse or severe mental illness (i.e., schizophrenia, bipolar disorder)
Other
- 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)
Who the study is looking for
- 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)
Age in the registry: 4 years to 6 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kennedy Krieger Institute Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.