Clinical trial NCT06066983: DINO RCT - Treating Anxiety in Children With Autism
Official title: Treating Anxiety in Young Children With Autism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Anxiety Disorders
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 70
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA)
timeFrame: Before and after 14-week treatment (baseline to post-treatment)
Secondary outcomes:
measure: Change in anxiety severity on Child Behavior Checklist
timeFrame: Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up
measure: Change in child's intolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale
timeFrame: Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up
measure: Change on parental accommodating behaviors on Family Accommodation Scale following 14-week active control and 14-week intervention.
timeFrame: Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
References:
citation: Keefer A, Vasa RA. DINOSAUR: an integrated cognitive-behavioral treatment for anxiety in young children with ASD. J Neurodev Disord. 2021 Oct 11;13(1):46. doi: 10.1186/s11689-021-09396-9.
citation: Vasa RA, Kerns CM, Singh V, McDonald R, Jang YS, Keefer A. Anxiety in autistic preschool children: Phenomenology and a network analysis of correlates. Autism Res. 2023 Aug;16(8):1561-1572. doi: 10.1002/aur.2968. Epub 2023 Jun 23.