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Behavioral Intervention

Cognitive Behavioral Therapy + Psychoeducation for Anxiety in Children With Autism

N/A
Recruiting
Research Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 4 years 0 months to 6 years 11 months
Receptive and expressive language age equivalent > 36 months based on Test of Early Language Development, Fourth Edition (TELD-4)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up
Awards & highlights

Summary

This trial seeks to reduce anxiety & intolerance of uncertainty in autistic children under 7, with few studies on this age range. Cognitive-behavioral therapy (CBT) approaches are being tested to see if they work.

Who is the study for?
This trial is for young children aged 4 to nearly 7 with autism who also show signs of anxiety. They should not have other neurological or genetic conditions, and must be able to communicate in basic English. A parent must join them for a 14-week online therapy program.
What is being tested?
The DINO RCT is testing a new telehealth cognitive-behavioral therapy called DINOSAUR, designed specifically for autistic children with anxiety. It aims to reduce their anxiety and intolerance of uncertainty over the course of the study.
What are the potential side effects?
Since this intervention involves behavioral therapy rather than medication, traditional side effects are not expected; however, participants may experience emotional discomfort or increased anxiety initially as they confront anxious feelings during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 4 and 6 years old.
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My language skills are at or above a 3-year-old level according to the TELD-4 test.
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I have been diagnosed with Autism Spectrum Disorder (ASD) based on clinical assessment and ADOS-2 results.
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I do not have conditions like epilepsy, Down syndrome, or severe vision problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA)
Secondary study objectives
Change in anxiety severity on Child Behavior Checklist
Change in child's intolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale
Change on parental accommodating behaviors on Family Accommodation Scale following 14-week active control and 14-week intervention.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Parent-child dyads will receive DINOSAUR, a group-based cognitive-behavioral therapy (CBT) intervention, adapted for young children and delivered via telehealth. This 14 week intervention teaches parents and children strategies to reduce anxiety and intolerance of uncertainty, an underlying construct of anxiety.
Group II: Active ControlActive Control1 Intervention
Parents in the active control condition will participate in three psychoeducational groups focused on presenting information regarding anxiety prevalence, differentiating anxiety from autism, and anxiety triggers. These groups will be delivered via telehealth across a 14-week period.

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Who is running the clinical trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Lead Sponsor
89 Previous Clinical Trials
24,793 Total Patients Enrolled
15 Trials studying Autism Spectrum Disorder
3,462 Patients Enrolled for Autism Spectrum Disorder
~47 spots leftby Oct 2026
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