Skip to content

Phenomenology of Anxiety in Preschool Children With ASD

Phenomenology of Anxiety in Preschool Children With Autism Spectrum Disorder

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04436432
Enrollment
75
Registered
2020-06-18
Start date
2018-10-25
Completion date
2021-07-01
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Autism Spectrum Disorder

Keywords

Autism, Anxiety, Eye tracking, Preschool

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.

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
36 Months to 71 Months
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

Design outcomes

Primary

MeasureTime frameDescription
Anxiety diagnostic status as measured by Anxiety Disorders Interview Schedule with Autism AddendumAnxiety diagnostic status will be measured through study completion, up to 24 monthsGold-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 paradigmsAttention to threat and correlated physiological arousal will be measured across the final 12 months of the studyChild'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

MeasureTime frameDescription
Screen for Child Anxiety Related DisordersAnxiety will be assessed through study completion, up to 24 monthsparent 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 ScaleIntolerance of uncertainty will be assessed through study completion, up to 24 monthsparent 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 ScaleASD symptoms will be assessed through study completion, up to 24 monthsparent 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 ChecklistEmotional regulation will be assessed through study completion, up to 24 monthsparent 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 QuestionnaireSleep habits will be assessed across the final 12 months of the studyparent report questionnaire that measures sleep habits in children; scores range from 45 to 135; higher scores indicate greater frequency of sleep problems
Child Behavior ChecklistAnxiety and other psychiatric symptoms will be assessed through study completion, up to 24 monthsparent 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
Intolerance of Uncertainty ScaleParental intolerance of uncertainty will be assessed through the completion of the study, up to 24 monthsscale 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 ScaleParental accommodation will be assessed through the completion of the study, up to 24 monthsassesses parental accommodation of child's interfering symptoms; scores range from 0 to 36; higher scores indicate higher parental accommodation
Burden Assessment ScaleParental strain will be assessed through study completion, up to 24 monthsmeasures 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 PhenotypeParental autism features will be assessed through study completion, up to 24 monthsself-report scale that measures broader autism symptoms in the parent; scores range from 36 to 216; higher scores indicate greater severity of autism features
Hospital Anxiety and Depression scaleParental anxiety and depression will be assessed through the completion of the study, up to 24 monthsscreening 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
Preschool Anxiety Scale - RevisedAnxiety will be assessed through study completion, up to 24 monthsparent and teacher report scale measuring levels of anxiety in preschool aged children; scores range from 0 to 112; higher scores indicate higher anxiety

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026