Phenomenology of Anxiety in Preschool Children With ASD

NCT04436432 | Completed

• 1 other identifier: IRB00173329
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Autism Spectrum Disorder

Keywords

Autism; Anxiety; Eye tracking; Preschool

Outcome Measures

Primary Outcomes (2)

• Anxiety diagnostic status as measured by Anxiety Disorders Interview Schedule with Autism Addendum

  Gold-standard semi-structured interview for assessing anxiety disorders and the ASA, a supplement to the ADIS that facilitates the use of this tool in children with ASD; clinical severity ratings range from 0 to 3 or 0 to 8; higher scores indicate more impairment

  Anxiety diagnostic status will be measured through study completion, up to 24 months

• Attention to threat behavioral paradigms

  Child's attention to threatening stimuli measured via eye tracking and correlated physiological response measures via pupillometry; more frequent saccades to threatening stimuli indicate higher attention bias to threat; greater pupil dilation indicates higher physiological arousal

  Attention to threat and correlated physiological arousal will be measured across the final 12 months of the study

Secondary Outcomes (12)

• Child Behavior Checklist

  Anxiety and other psychiatric symptoms will be assessed through study completion, up to 24 months

• Preschool Anxiety Scale - Revised

  Anxiety will be assessed through study completion, up to 24 months

• Screen for Child Anxiety Related Disorders

  Anxiety will be assessed through study completion, up to 24 months

• Response to Uncertainty and Low Environmental Stability Scale

  Intolerance of uncertainty will be assessed through study completion, up to 24 months

• Social Responsiveness Scale

  ASD symptoms will be assessed through study completion, up to 24 months

Study Arms (1)

Assessment

Children with ASD ages 3-5 years at baseline

Eligibility Criteria

• Age: 36 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Clinical and community based sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

Related Publications (2)

• 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.

  PMID: 29316350 BACKGROUND

• 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.

  PMID: 29164436 BACKGROUND

Related Links

• Study Flier

MeSH Terms

Conditions

Anxiety Disorders; Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Officials

• Roma A Vasa, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Psychiatric Services

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 18, 2020
• Study Start: October 25, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)