Recruiting

DINOSAUR

Sponsor:

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Code:

NCT06066983

Conditions

Autism Spectrum Disorder

Anxiety Disorders

Eligibility Criteria

Sex: All

Age: 4 - 6

Healthy Volunteers: Accepted

Interventions

DINOSAUR

Psychoeducation

Study Details

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

Study ID

NCT06066983

Start date

Jan 2, 2024

Status verified date

Apr, 2026

Completion date

Oct 15, 2026

Anticipated

Primary completion date

Oct 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 6

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

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.

active comparator: Active Control

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.

Interventions

DINOSAUR

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

Psychoeducation

This intervention provides psychoeducation regarding anxiety and autism.

Primary outcome measure

  • Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA) [ Time Frame: Before and after 14-week treatment (baseline to post-treatment) ]

Central Contacts and Locations

Central contacts

Belina Onomake

667-205-4036OnomakeB@kennedykrieger.org

Amy Keefer, PhD

443-923-7603keefer@kennedykrieger.org

Locations

Kennedy Krieger Institute

Recruiting

Baltimore, Maryland, United States, 21211

Contacts

Belina Onomake

667-205-4036OnomakeB@kennedykrieger.org

Principal Investigator:

Amy Keefer, PhD

More Information

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. on 2026-04-23.