NCT06066983 DINO RCT - Treating Anxiety in Children With Autism
| NCT ID | NCT06066983 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-01-02 |
| Primary Completion | 2026-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-01-02 with a primary completion date of 2026-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06066983 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 6 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06066983 currently recruiting?
Yes, NCT06066983 is actively recruiting participants. Contact the research team at OnomakeB@kennedykrieger.org for enrollment information.
Where is the NCT06066983 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06066983 clinical trial?
NCT06066983 is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. The trial plans to enroll 70 participants.