DINO RCT - Treating Anxiety in Children With Autism

NCT06066983 | Recruiting

• 2 other identifiers: IRB00343724CDMRP - AR220066
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in anxiety severity on Child Behavior Checklist

  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

  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.

  Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up

Study Arms (2)

Treatment

EXPERIMENTAL

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

Active Control

ACTIVE COMPARATOR

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

Interventions

DINOSAUR BEHAVIORAL

This intervention aims to treat intolerance of uncertainty and anxiety in young autistic children.

Treatment

Psychoeducation OTHER

This intervention provides psychoeducation regarding anxiety and autism.

Active Control

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

RECRUITING

Related 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.

  PMID: 34635048 RESULT

• 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.

  PMID: 37350221 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Belina Onomake

CONTACT

667-205-4036; OnomakeB@kennedykrieger.org

Amy Keefer, PhD

CONTACT

443-923-7603; keefer@kennedykrieger.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 4, 2023
• Study Start: January 2, 2024
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)