DINO RCT - Treating Anxiety in Children With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

Treating Anxiety in Young Children With Autism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06066983
• Other study ID #: IRB00343724
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: October 15, 2026

Study information

• Verified date: February 2024
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: Nicole Nichols
• Phone: 667-205-4036
• Email: NicholsN[@]kennedykrieger.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 15, 2026
• Est. primary completion date: October 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• DINOSAUR
This intervention aims to treat intolerance of uncertainty and anxiety in young autistic children.

Other:
• Psychoeducation
This intervention provides psychoeducation regarding anxiety and autism.

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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