Phenomenology of Anxiety in Preschool Children With ASD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phenomenology of Anxiety in Preschool Children With Autism Spectrum Disorder

Conditions
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Autism Spectrum Disorder, Anxiety

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 71 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Assessment<br>Children with ASD ages 3-5 years at baseline | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Behavior Checklist | 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 | Anxiety and other psychiatric symptoms will be assessed through study completion, up to 24 months | 
| Preschool Anxiety Scale - Revised | parent and teacher report scale measuring levels of anxiety in preschool aged children; scores range from 0 to 112; higher scores indicate higher anxiety | Anxiety will be assessed through study completion, up to 24 months | 
| Screen for Child Anxiety Related Disorders | 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 | Anxiety will be assessed through study completion, up to 24 months | 
| Response to Uncertainty and Low Environmental Stability Scale | 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 | Intolerance of uncertainty will be assessed through study completion, up to 24 months | 
| Social Responsiveness Scale | 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 | ASD symptoms will be assessed through study completion, up to 24 months | 
| Emotion Regulation Checklist | parent report scale that assesses emotion regulation capacities in children; scores range from 24 to 96; higher scores indicate higher impairment | Emotional regulation will be assessed through study completion, up to 24 months | 
| The Children's Sleep Habits Questionnaire | parent report questionnaire that measures sleep habits in children; scores range from 45 to 135; higher scores indicate greater frequency of sleep problems | Sleep habits will be assessed across the final 12 months of the study | 
| Hospital Anxiety and Depression scale | 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 | Parental anxiety and depression will be assessed through the completion of the study, up to 24 months | 
| Intolerance of Uncertainty Scale | 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 | Parental intolerance of uncertainty will be assessed through the completion of the study, up to 24 months | 
| Family Accommodation Scale | assesses parental accommodation of child's interfering symptoms; scores range from 0 to 36; higher scores indicate higher parental accommodation | Parental accommodation will be assessed through the completion of the study, up to 24 months | 
| Burden Assessment Scale | 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 | Parental strain will be assessed through study completion, up to 24 months | 
| Broader Autism Phenotype | 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 | Parental autism features will be assessed through study completion, up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, Anxiety, Eye tracking, Preschool