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Completed

NCT Number: NCT04436432

Phenomenology of Anxiety in Preschool Children With ASD

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.

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Key information

Conditions

Anxiety Anxiety Disorders Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

36 month–71 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Phenomenology of Anxiety in Preschool Children With Autism Spectrum Disorder

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 18, 2020
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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