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Tests a telehealth program for anxiety in young autistic children

Tests an online therapy program for anxiety in autistic children aged 4 to 6.

Plain-language title generated from the registry record
Registry title: DINO RCT - Treating Anxiety in Children With Autism

Key facts

Where
Baltimore, United StatesSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 4 and 6 years old?

Source: NCT06066983, who can take part

Where in United States

  • Kennedy Krieger InstituteBaltimore, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Trial code
NCT06066983
Record updated
4 November 2026
Original description
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.Read full original descriptionShow less

Treating Anxiety in Young 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.

Inclusion: 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: Participating parent experiencing active symptoms of substance abuse or severe mental illness (i.e., schizophrenia, bipolar disorder); 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).

ClinicalTrials.gov NCT06066983