Clinical trial NCT04436432: Phenomenology of Anxiety in Preschool Children With ASD
Official title: Phenomenology of Anxiety in Preschool Children With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Autism Spectrum Disorder
Keywords: Autism
Anxiety
Eye tracking
Preschool
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 75
Sex: ALL
Minimum age (years): 36
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical and community based sample

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety diagnostic status as measured by Anxiety Disorders Interview Schedule with Autism Addendum
timeFrame: Anxiety diagnostic status will be measured through study completion, up to 24 months
measure: Attention to threat behavioral paradigms
timeFrame: Attention to threat and correlated physiological arousal will be measured across the final 12 months of the study
Secondary outcomes:
measure: Child Behavior Checklist
timeFrame: Anxiety and other psychiatric symptoms will be assessed through study completion, up to 24 months
measure: Preschool Anxiety Scale - Revised
timeFrame: Anxiety will be assessed through study completion, up to 24 months
measure: Screen for Child Anxiety Related Disorders
timeFrame: Anxiety will be assessed through study completion, up to 24 months
measure: Response to Uncertainty and Low Environmental Stability Scale
timeFrame: Intolerance of uncertainty will be assessed through study completion, up to 24 months
measure: Social Responsiveness Scale
timeFrame: ASD symptoms will be assessed through study completion, up to 24 months
measure: Emotion Regulation Checklist
timeFrame: Emotional regulation will be assessed through study completion, up to 24 months
measure: The Children's Sleep Habits Questionnaire
timeFrame: Sleep habits will be assessed across the final 12 months of the study
measure: Hospital Anxiety and Depression scale
timeFrame: Parental anxiety and depression will be assessed through the completion of the study, up to 24 months
measure: Intolerance of Uncertainty Scale
timeFrame: Parental intolerance of uncertainty will be assessed through the completion of the study, up to 24 months
measure: Family Accommodation Scale
timeFrame: Parental accommodation will be assessed through the completion of the study, up to 24 months
measure: Burden Assessment Scale
timeFrame: Parental strain will be assessed through study completion, up to 24 months
measure: Broader Autism Phenotype
timeFrame: Parental autism features will be assessed through study completion, up to 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Roma A Vasa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.