Status:
COMPLETED
Anxiety Intervention for Preschool Children With ASD
Lead Sponsor:
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborating Sponsors:
Organization for Autism Research
Conditions:
Anxiety Disorder
Autism Spectrum Disorder
Eligibility:
All Genders
48-83 years
Phase:
NA
Brief Summary
This study evaluates the feasibility, acceptability, and preliminary efficacy of a treatment program for anxiety in preschool children with autism spectrum disorder.
Detailed Description
Anxiety is highly prevalent in individuals with ASD with lifelong impact. In this population, anxiety often emerges when children are very young, yet there are no evidence-based treatments for this ag...
Eligibility Criteria
Inclusion
- Age 4 years 0 months to 6 years 11 months
- NVIQ ≥ 85 based on Mullen Scales of Early Learning or Stanford Binet 5
- Expressive and Receptive Language scores ≥ 85 based on Preschool Language Scale - Fifth Edition or Orals or Written Language Scales, Second Edition
- DSM-5 diagnoses of Separation Anxiety, Social Anxiety, and/or Generalized Anxiety Disorder and/or the distinct diagnosis of Other Social Fear based on the results of the Anxiety Disorders Interview Schedule/ASA
Exclusion
- History of psychological trauma
- History of neurologic illness
- Parent substance abuse, bipolar disorder, psychosis
- Parents require support from a medical interpreter
- Child displays severe behavior challenges
- Severe eyesight or hearing impairments that may interfere with the protocols
- Child's behavior prevents their ability to participate in a 1 hour group consisting of various activities (e.g., listening to a story, snacks, playing movement games, completing a craft)
Key Trial Info
Start Date :
October 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04432077
Start Date
October 12 2020
End Date
October 1 2022
Last Update
October 14 2022
Active Locations (1)
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1
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21211