No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
4 – 6
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Other
Who this trial is looking for
This trial is looking for young children with autism and anxiety aged 4 to 6 years. Participants will join a 14-week program using telehealth to help reduce anxiety and intolerance of uncertainty.
Are You a Good Fit for This Trial?
Rules you outEpilepsyDown syndromeFragile X syndromeTuberous sclerosisNeurofibromatosisSevere vision impairment
You may be able to join if
I am between 4 and 6 years old.
I have been diagnosed with autism.
I have anxiety problems.
I can understand and speak at least at a 3-year-old's level.
I have a parent or caregiver who can attend the program with me.
I can walk on my own.
You may not be able to join if
I primarily speak a language other than English.
I am in foster care.
I have severe behavior issues like aggression or self-injury.
My parent has serious mental health issues.
My parent has active substance abuse problems.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 autist…
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.
Trial Locations
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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 m…
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)
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