Phenomenology of Anxiety in Preschool Children With ASD

Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT04436432
Collaborator
(none)
75
1
32.2
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    75 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Phenomenology of Anxiety in Preschool Children With Autism Spectrum Disorder
    Actual Study Start Date :
    Oct 25, 2018
    Actual Primary Completion Date :
    Jul 1, 2021
    Actual Study Completion Date :
    Jul 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Assessment

    Children with ASD ages 3-5 years at baseline

    Outcome Measures

    Primary Outcome Measures

    1. Anxiety diagnostic status as measured by Anxiety Disorders Interview Schedule with Autism Addendum [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 [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 Outcome Measures

    1. Child Behavior Checklist [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    36 Months to 71 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kennedy Krieger Institute Baltimore Maryland United States 21211

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Roma A Vasa, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Roma Vasa, Director of Psychiatric Services, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
    ClinicalTrials.gov Identifier:
    NCT04436432
    Other Study ID Numbers:
    • IRB00173329
    First Posted:
    Jun 18, 2020
    Last Update Posted:
    Nov 24, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Roma Vasa, Director of Psychiatric Services, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 24, 2021