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DINO RCT: Treating Anxiety in Children With Autism

This study is testing a new treatment called DINOSAUR for anxiety in young children with autism. Anxiety is common in autistic children, but there aren't many studies for this age group. DINOSAUR aims to help children with autism who also have anxiety by addressing their intolerance of uncertainty (difficulty handling unpredictable situations). Researchers want to see if DINOSAUR is a practical treatment for families and if it works better than standard psychoeducation (learning about anxiety and autism). The study is for children aged 4 to 6 years old with an autism diagnosis and significant anxiety. The goal is to see if DINOSAUR can reduce anxiety. The current recruitment status is unclear.

Study design
This study will randomly assign 70 children (35 in each group) to receive either the DINOSAUR treatment or psychoeducation over 14 weeks via telehealth.
What's involved
Participants will receive 14 weeks of treatment via telehealth. Anxiety and intolerance of uncertainty will be assessed after treatment and at a 4-month follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 4 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06066983

DINO RCT - Treating Anxiety in Children With Autism

Recruiting
NAAges 4–6InterventionalTreatment
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
~70 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:DINOSAURPsychoeducation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA)
Measured over Before and after 14-week treatment (baseline to post-treatment)

Conditions

Autism Spectrum Disorder
Anxiety Disorders

Explore related trials

Anxiety DisorderAutism Spectrum Disorder

NCT06066983

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Kennedy Krieger Institute

    Baltimore, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Belina Onomake
[email protected]
667-205-4036
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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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)

What this trial measures

  • Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA)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.