Anxiety Intervention for Preschool Children With ASD

Study Overview
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Brief Summary
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This study evaluates the feasibility, acceptability, and preliminary efficacy of a treatment program for anxiety in preschool children with autism spectrum disorder.

Detailed Description
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Anxiety is highly prevalent in individuals with ASD with lifelong impact. In this population, anxiety often emerges when children are very young, yet there are no evidence-based treatments for this age group. Cognitive-behavioral treatment (CBT) successfully reduces anxiety levels in young, typically developing children and older children with ASD. This study pilots the DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR) program, which is an integrated treatment program that utilizes CBT modified for young children with ASD. The treatment includes heavy doses of parent training to reduce accommodation of the child's anxiety symptoms and interventions targeting fear of uncertainty, a common fear in children with ASD. The feasibility, acceptability, and preliminary efficacy of this treatment program will be studied.

Official Title
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Piloting an Integrated Anxiety Intervention for Preschool Children With Autism Spectrum Disorder

Conditions
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Anxiety Disorder, Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 4 years 0 months to 6 years 11 months NVIQ ≥ 85 based on Mullen Scales of Early Learning or Stanford Binet 5 Expressive and Receptive Language scores ≥ 85 based on Preschool Language Scale - Fifth Edition or Orals or Written Language Scales, Second Edition DSM-5 diagnoses of Separation Anxiety, Social Anxiety, and/or Generalized Anxiety Disorder and/or the distinct diagnosis of Other Social Fear based on the results of the Anxiety Disorders Interview Schedule/ASA 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 Child's behavior prevents their ability to participate in a 1 hour group consisting of various activities (e.g., listening to a story, snacks, playing movement games, completing a craft)

Ages Eligible for Study
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Minimum Age: 48 Months
Maximum Age: 83 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>All participants receive the DINOSAUR intervention | Behavioral: DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)<br>* DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR) - a parent-mediated cognitive-behavioral treatment modified for young children with ASD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA) after 12-week waitlist and 12-week intervention | clinician administered, semi-structured interview assessing anxiety disorders; clinical severity ratings range from 0 to 3 or 0 to 8; higher scores indicate more impairment | Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week treatment (pre-treatment to post-treatment) | 
| Improvement in child anxiety symptoms on Clinical Global Impressions Scale-Improvement following 12-week intervention | used to assess treatment response; scores range from 1 (very much improved) to 7 (very much worse) | Following 12-week intervention (post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child anxiety symptoms on Preschool Anxiety Scale - Revised following 12-week waitlist and 12-week intervention | parent and teacher report scale measuring levels of anxiety in preschool aged children; scores range from 0 to 112; higher scores indicate higher anxiety | Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment) | 
| Change in child anxiety symptoms on the Screen for Child Anxiety Related Disorders following 12-week waitlist and 12-week intervention | parent and teacher report scale measuring levels of anxiety in children older than 5 years old; scores range from 0 to 114; higher scores indicate higher anxiety | Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment) | 
| Change in severity of anxiety and other psychiatric symptoms on Child Behavior Checklist following 12-week waitlist and 12-week intervention | an established 99-item parent and teacher report of broad psychopathology; T scores range from 20 to 100; Syndrome scales: T-scores over 65 indicate clinically significant symptoms | Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment) | 
| Change in child's tolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale following 12-week waitlist and 12-week intervention | parent and teacher report scale measuring response to uncertainty and low environmental structure; scores range from 1 to 5; higher scores indicate higher intolerance of uncertainty | Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment) | 
| Change in child ASD symptoms on Social Responsiveness Scale following 12-week waitlist and 12-week intervention | 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 | Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment) | 
| Change in child repetitive behaviors on Repetitive Behavior Scale-Revised following 12-week waitlist and 12-week intervention | parent-report measure of repetitive behavior in children with ASD; scores range from 0 to 176; higher scores indicate greater impairment | Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment) | 
| Change in parental anxiety and depression symptoms on Hospital Anxiety and Depression Scale following 12-week waitlist and 12-week intervention | parental screening tool that captures clinical anxiety and depression; scores range from 0 to 21; higher scores indicate higher anxiety and/or depression symptoms | Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment) | 
| Change in parental tolerance of uncertainty on Intolerance of Uncertainty Scale following 12-week waitlist and 12-week intervention | parental scale that measures responses to uncertainty, ambiguous situations and the future; scores range from 12 to 60; higher scores indicate higher intolerance of uncertainty | Before and after 12-week wailist (baseline to pre-treatment); Before and after 12-week intervention | 
| Change on parental accommodating behaviors on Family Accommodation Scale following 12-week waitlist and 12-week intervention | assesses parental accommodating behaviors; scores range from 0 to 36; higher scores indicate higher parental accommodation | Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment) | 
| Change in child attention bias to threat on Behavioral Paradigms following 12-week waitlist and 12-week intervention | eye tracking paradigms used to assess attention bias to threat; more frequent saccades to threatening stimuli indicate higher attention bias to threat | Before and after 12-week waitlist (pre-treatment to post-treatment); Before and after 12-week intervention (pre-treatment to post-treatment) |