Phenomenology of Anxiety in Preschool Children With ASD

NCT ID: NCT04436432

Last Updated: 2021-11-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-25

Study Completion Date

2021-07-01

Brief Summary

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This study investigates the prevalence, phenomenology, and correlates of anxiety in preschool children with autism spectrum disorder (ASD) across a two-year period. Attention bias to threat, a potential objective marker of anxiety, also is examined using eye tracking methods.

Detailed Description

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Anxiety disorders in children with autism spectrum disorders (ASD) are one of the most prevalent and impairing co-occurring conditions, affecting approximately 40% of the population and causing major disruptions in school and family life. Research in typically developing (TD) children suggests that anxiety usually emerges in the preschool years (3-5 years) and can result in future psychopathology. Early detection and treatment of childhood anxiety in children with ASD can lead to improved clinical outcomes.

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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Anxiety Autism Spectrum Disorder

Keywords

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Autism Anxiety Eye tracking Preschool

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* Age 3 years 0 months to 5 years 11 months;
* 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 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
Minimum Eligible Age

36 Months

Maximum Eligible Age

71 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Roma Vasa

Director of Psychiatric Services

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 29316350 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29164436 (View on PubMed)

Other Identifiers

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IRB00173329

Identifier Type: -

Identifier Source: org_study_id