DINO RCT - Treating Anxiety in Children With Autism

Study Overview
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Brief Summary
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Anxiety is prevalent in young children, under 7 years of age, with autism. Yet, few studies have examined anxiety interventions for this age range, and only one anxiety treatment study has included young children with cognitive and language delays. Anxiety treatment models utilizing cognitive-behavioral therapy (CBT), adapted for children with autism, are empirically supported in school-age autistic children. Further, preliminary evidence suggests CBT approaches may reduce intolerance of uncertainty (IU), a mechanistic construct that may contribute to the maintenance of anxiety in autistic children. This study seeks to address the existing gap in anxiety treatment by examining the feasibility and preliminary efficacy of a novel, telehealth CBT intervention, DINO Strategies for Anxiety and intolerance of Uncertainty Reduction (DINOSAUR), which targets both anxiety and IU in young autistic children.

Detailed Description
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The purpose of this study is to examine the feasibility and preliminary efficacy of a new treatment that targets both anxiety and IU, i.e., DINOSAUR, in young autistic children with varying cognitive and language levels. To accomplish this goal, we will investigate if DINOSAUR is a feasible intervention for families of young autistic children. We will also investigate if DINOSAUR is superior to an active control condition in reducing anxiety and IU. A third, exploratory goal is to understand how children's language and cognitive level affect their response to anxiety treatment. Seventy children, 4-6 years of age with autism and clinically significant anxiety, and their parents will be randomly assigned to receive either DINOSAUR or the active control (35 in each group) over 14 weeks via telehealth. Within each condition, children will be stratified based on cognitive level. Anxiety and IU will be assessed following treatment and at 4-month follow-up.

Official Title
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Treating Anxiety in Young Children With Autism

Conditions
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Autism Spectrum Disorder, Anxiety Disorders

Intervention / Treatment
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* Behavioral: DINOSAUR
* Other: Psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 4 years 0 months to 6 years 11 months DSM-5 ASD diagnosis based on clinical impressions and results of the Autism Diagnostic Observation Schedule-2 (ADOS-2) CBCL Anxiety Problems T-score > 65 SB-5 ABIQ > 60 Receptive and expressive language age equivalent > 36 months based on Test of Early Language Development, Fourth Edition (TELD-4) Parent (or other caregiver) available and willing to attend 14-week intervention Absence of identifiable neurological (e.g., epilepsy), genetic (e.g., Down syndrome, fragile X, tuberous sclerosis, neurofibromatosis) or severe sensory-motor (e.g., severe vision impairment) conditions Able to walk independently (a requirement for ADOS-2) Exclusion Criteria: Primary language other than English Child is in foster care Child displays severe behavior challenges that prevent participation in treatment groups (i.e., severe tantrums, aggression, or self-injury) Participating parent experiencing active symptoms of substance abuse or severe mental illness (i.e., schizophrenia, bipolar disorder)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Parent-child dyads will receive DINOSAUR, a group-based cognitive-behavioral therapy (CBT) intervention, adapted for young children and delivered via telehealth. This 14 week intervention teaches parents and children strategies to reduce anxiety and intolerance of uncertainty, an underlying construct of anxiety. | Behavioral: DINOSAUR<br>* This intervention aims to treat intolerance of uncertainty and anxiety in young autistic children.<br>|
| Active Comparator: Active Control<br>Parents in the active control condition will participate in three psychoeducational groups focused on presenting information regarding anxiety prevalence, differentiating anxiety from autism, and anxiety triggers. These groups will be delivered via telehealth across a 14-week period. | Other: Psychoeducation<br>* This intervention provides psychoeducation regarding anxiety and autism.<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) | The Anxiety Disorders Interview Schedule (ADIS) is a semi-structured parent interview assessing the severity of anxiety disorders and its presentation in individuals with autism. | Before and after 14-week treatment (baseline to post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety severity on Child Behavior Checklist | 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 14-week treatment (baseline to post-treatment) and at 4 month follow-up | 
| Change in child's intolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale | 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 14-week treatment (baseline to post-treatment) and at 4 month follow-up | 
| Change on parental accommodating behaviors on Family Accommodation Scale following 14-week active control and 14-week intervention. | Assesses parental accommodating behaviors; scores range from 0 to 36; higher scores indicate higher parental accommodation. | Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up |