AnxietyNCT04436432
Phenomenology of Anxiety in Preschool Children With ASD
An observational study of Anxiety and Autism Spectrum Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 36 to 71 months
- Conditions the study is for
- Anxiety, Autism Spectrum Disorder
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2018to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 71 months
- All sexes
- No healthy volunteers
- Child
Study population: Clinical and community based sample
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21211
About this study
Official title: Phenomenology of Anxiety in Preschool Children With Autism Spectrum Disorder
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.
Read the 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.
- Conditions
- Anxiety, Autism Spectrum Disorder
- Keywords
- Autism, Anxiety, Eye tracking, Preschool
- Medical subject headings
- Anxiety Disorders, Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Assessment | Children with ASD ages 3-5 years at baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Attention to threat and correlated physiological arousal will be measured across the final 12 months of the study
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Parental autism features will be assessed through study completion, up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start25 Oct 2018
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roma Vasa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Roma A Vasa, M.D., Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436432
- Sponsor's protocol ID
- IRB00173329
- Status last verified
- Nov 2021
- First submitted
- 4 Jun 2020
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29316350Vasa 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.
PubMed 29164436
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenomenology of Anxiety in Preschool Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT04436432
- Acronym / sponsor ID
- IRB00173329
- Conditions
- Anxiety, Autism Spectrum Disorder
- Keywords
- Autism, Anxiety, Eye tracking, Preschool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment | – | –Children with ASD ages 3-5 years at baseline |
Who may qualify
- Ages
- 36 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Clinical and community based sample
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anxiety diagnostic status as measured by Anxiety Disorders Interview Schedule with Autism Addendum
Time frame: 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
Attention to threat behavioral paradigms
Time frame: 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
12 secondary outcomes
Child Behavior Checklist
Time frame: Anxiety and other psychiatric symptoms will be assessed through study completion, up to 24 months
Preschool Anxiety Scale - Revised
Time frame: Anxiety will be assessed through study completion, up to 24 months
Screen for Child Anxiety Related Disorders
Time frame: Anxiety will be assessed through study completion, up to 24 months
Response to Uncertainty and Low Environmental Stability Scale
Time frame: Intolerance of uncertainty will be assessed through study completion, up to 24 months
Social Responsiveness Scale
Time frame: ASD symptoms will be assessed through study completion, up to 24 months
Emotion Regulation Checklist
Time frame: Emotional regulation will be assessed through study completion, up to 24 months
The Children's Sleep Habits Questionnaire
Time frame: Sleep habits will be assessed across the final 12 months of the study
Hospital Anxiety and Depression scale
Time frame: Parental anxiety and depression will be assessed through the completion of the study, up to 24 months
Intolerance of Uncertainty Scale
Time frame: Parental intolerance of uncertainty will be assessed through the completion of the study, up to 24 months
Family Accommodation Scale
Time frame: Parental accommodation will be assessed through the completion of the study, up to 24 months
Burden Assessment Scale
Time frame: Parental strain will be assessed through study completion, up to 24 months
Broader Autism Phenotype
Time frame: Parental autism features will be assessed through study completion, up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Background: PubMed 29316350Vasa 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.
- Background: PubMed 29164436Vasa 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.
- Study FlierLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roma A Vasa, M.D. principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Autism Spectrum Disorder, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety diagnostic status as measured by Anxiety Disorders Interview Schedule with Autism Addendum (time frame: Anxiety diagnostic status will be measured through study completion, up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04436432, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.