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NCT Number: NCT06066983

DINO RCT - Treating Anxiety in Children With Autism

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.

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Key information

Conditions

Autism Spectrum Disorder Anxiety Disorders Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location status: Recruiting

Location contact

Amy Keefer, PhD

PRINCIPAL_INVESTIGATOR

Belina Onomake

CONTACT

[email protected]

667-205-4036

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DINOSAUR

Behavioral

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

Psychoeducation

Other

This intervention provides psychoeducation regarding anxiety and autism.

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. Change in anxiety severity on Child Behavior Checklist

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

    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.

  2. Change in child's intolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale

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

    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.

  3. Change on parental accommodating behaviors on Family Accommodation Scale following 14-week active control and 14-week intervention.

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

    Assesses parental accommodating behaviors; scores range from 0 to 36; higher scores indicate higher parental accommodation.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Keefer, PhD

CONTACT

[email protected]

443-923-7603

Belina Onomake

CONTACT

[email protected]

667-205-4036

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Treating Anxiety in Young Children With Autism

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2023
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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