Phenomenology of Anxiety in Preschool Children With ASD

Overview

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.

Full Title of Study: “Phenomenology of Anxiety in Preschool Children With Autism Spectrum Disorder”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2022

Detailed Description

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.

Arms, Groups and Cohorts

  • Assessment
    • Children with ASD ages 3-5 years at baseline

Clinical Trial Outcome Measures

Primary Measures

  • Anxiety diagnostic status as measured by Anxiety Disorders Interview Schedule with Autism Addendum
    • Time Frame: Anxiety diagnostic status will be measured through study completion, up to 24 months
    • 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
  • Attention to threat behavioral paradigms
    • Time Frame: Attention to threat and correlated physiological arousal will be measured across the final 12 months of the study
    • 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

Secondary Measures

  • Child Behavior Checklist
    • Time Frame: Anxiety and other psychiatric symptoms will be assessed through study completion, up to 24 months
    • parent and teacher report scale that measures child anxiety and other psychiatric symptoms;T scores range from 20 to 100; Syndrome scales: T-scores over 65 indicate clinically significant symptoms
  • Preschool Anxiety Scale – Revised
    • Time Frame: Anxiety will be assessed through study completion, up to 24 months
    • parent and teacher report scale measuring levels of anxiety in preschool aged children; scores range from 0 to 112; higher scores indicate higher anxiety
  • Screen for Child Anxiety Related Disorders
    • Time Frame: Anxiety will be assessed through study completion, up to 24 months
    • parent and teacher report scale measuring levels of anxiety in children 6 or older; scores range from 0 to 114; higher scores indicate higher anxiety
  • Response to Uncertainty and Low Environmental Stability Scale
    • Time Frame: Intolerance of uncertainty will be assessed through study completion, up to 24 months
    • parent and teacher report scale measuring response to uncertainty and low environmental structure in children; scores range from 1 to 5; higher scores indicate higher intolerance of uncertainty
  • Social Responsiveness Scale
    • Time Frame: ASD symptoms will be assessed through study completion, up to 24 months
    • parent report scale that assesses the presence and severity of social impairment in children; T-scores range from 20 to 100; higher scores indicate higher ASD severity
  • Emotion Regulation Checklist
    • Time Frame: Emotional regulation will be assessed through study completion, up to 24 months
    • parent report scale that assesses emotion regulation capacities in children; scores range from 24 to 96; higher scores indicate higher impairment
  • The Children’s Sleep Habits Questionnaire
    • Time Frame: Sleep habits will be assessed across the final 12 months of the study
    • parent report questionnaire that measures sleep habits in children; scores range from 45 to 135; higher scores indicate greater frequency of sleep problems
  • Hospital Anxiety and Depression scale
    • Time Frame: Parental anxiety and depression will be assessed through the completion of the study, up to 24 months
    • screening tool that will be used to capture clinical anxiety and depression in parents; scores range from 0 to 21; higher scores indicate higher anxiety and/or depression symptoms
  • Intolerance of Uncertainty Scale
    • Time Frame: Parental intolerance of uncertainty will be assessed through the completion of the study, up to 24 months
    • scale that will be used to measure parental responses to uncertainty, ambiguous situations and the future; scores range from 12 to 60; higher scores indicate higher intolerance of uncertainty
  • Family Accommodation Scale
    • Time Frame: Parental accommodation will be assessed through the completion of the study, up to 24 months
    • assesses parental accommodation of child’s interfering symptoms; scores range from 0 to 36; higher scores indicate higher parental accommodation
  • Burden Assessment Scale
    • Time Frame: Parental strain will be assessed through study completion, up to 24 months
    • measures strain (thoughts, feelings, disruption) associated with having a child with a neurodevelopmental disorder; scores range from 19 to 76; higher scores indicate greater family burden
  • Broader Autism Phenotype
    • Time Frame: Parental autism features will be assessed through study completion, up to 24 months
    • self-report scale that measures broader autism symptoms in the parent; scores range from 36 to 216; higher scores indicate greater severity of autism features

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 36 Months

Maximum Age: 71 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Roma Vasa, Director of Psychiatric Services – Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  • Overall Official(s)
    • Roma A Vasa, M.D., Principal Investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  • Overall Contact(s)
    • Rachel McDonald, M.S., 667-205-4036, mcdon@kennedykrieger.org

References

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.

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