NCT06066983 · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
DINO RCT - Treating Anxiety in Children With Autism
What this 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.
View original scientific description
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.
Interventions
BEHAVIORAL
DINOSAUR
This intervention aims to treat intolerance of uncertainty and anxiety in young autistic children.
OTHER
Psychoeducation
This intervention provides psychoeducation regarding anxiety and autism.
Primary outcome measures
Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA)
Time frame: Before and after 14-week treatment (baseline to post-treatment)
The Anxiety Disorders Interview Schedule (ADIS) is a semi-structured parent interview assessing the severity of anxiety disorders and its presentation in individuals with autism.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2026 · Source of record for eligibility and locations