Phenomenology of Anxiety in Preschool Children With ASD

Anxiety Clinical Trial

Official title:

Phenomenology of Anxiety in Preschool Children With Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04436432
• Other study ID #: IRB00173329
• Status: Completed
• Start date: October 25, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: November 2021
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Months to 71 Months

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Autism Spectrum Disorder
• Autistic Disorder

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Study Flier