Phenomenology of Anxiety in Preschool Children With ASD
NCT ID: NCT04436432
Last Updated: 2021-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
75 participants
OBSERVATIONAL
2018-10-25
2021-07-01
Brief Summary
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Detailed Description
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This study assesses the prevalence and phenomenology of anxiety in preschool children with ASD utilizing an established and comprehensive measure of anxiety in children with ASD across three time points (baseline, one year post, two years post).It also investigates the association of child (e.g., ASD features) and parent (e.g., mental health, caregiver strain) characteristics with anxiety cross-sectionally and longitudinally, to determine if certain correlates predict or maintain future anxiety. Attention bias to threat stimuli and its physiological correlates are also examined as potential objective markers of anxiety using eye tracking and pupillometry methods.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Assessment
Children with ASD ages 3-5 years at baseline
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* DSM-5 ASD diagnosis based on clinical impressions and results of the Autism Diagnostic Observation Schedule-2 (ADOS-2)
* Child resides with at least one biological parent
* Parents are English speaking
Exclusion Criteria
* 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
36 Months
71 Months
ALL
No
Sponsors
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Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
OTHER
Responsible Party
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Roma Vasa
Director of Psychiatric Services
Principal Investigators
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Roma A Vasa, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Locations
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Kennedy Krieger Institute
Baltimore, Maryland, United States
Countries
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References
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Vasa RA, Kreiser NL, Keefer A, Singh V, Mostofsky SH. Relationships between autism spectrum disorder and intolerance of uncertainty. Autism Res. 2018 Apr;11(4):636-644. doi: 10.1002/aur.1916. Epub 2018 Jan 7.
Vasa RA, Keefer A, Reaven J, South M, White SW. Priorities for Advancing Research on Youth with Autism Spectrum Disorder and Co-occurring Anxiety. J Autism Dev Disord. 2018 Mar;48(3):925-934. doi: 10.1007/s10803-017-3320-0.
Related Links
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Other Identifiers
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IRB00173329
Identifier Type: -
Identifier Source: org_study_id