RECRUITING

DINO RCT - Treating Anxiety in Children With Autism

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Treating Anxiety in Young Children With Autism

Quick Facts

Study Start:2024-01-02
Study Completion:2026-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06066983

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age 4 years 0 months to 6 years 11 months
  2. * DSM-5 ASD diagnosis based on clinical impressions and results of the Autism Diagnostic Observation Schedule-2 (ADOS-2)
  3. * CBCL Anxiety Problems T-score \> 65
  4. * SB-5 ABIQ \> 60
  5. * Receptive and expressive language age equivalent \> 36 months based on Test of Early Language Development, Fourth Edition (TELD-4)
  6. * Parent (or other caregiver) available and willing to attend 14-week intervention
  7. * 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
  8. * Able to walk independently (a requirement for ADOS-2)
  1. * Primary language other than English
  2. * Child is in foster care
  3. * Child displays severe behavior challenges that prevent participation in treatment groups (i.e., severe tantrums, aggression, or self-injury)
  4. * Participating parent experiencing active symptoms of substance abuse or severe mental illness (i.e., schizophrenia, bipolar disorder)

Contacts and Locations

Study Contact

Nicole Nichols
CONTACT
667-205-4036
NicholsN@kennedykrieger.org
Amy Keefer, PhD
CONTACT
443-923-7603
keefer@kennedykrieger.org

Study Locations (Sites)

Kennedy Krieger Institute
Baltimore, Maryland, 21211
United States

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-02
Study Completion Date2026-10-15

Study Record Updates

Study Start Date2024-01-02
Study Completion Date2026-10-15

Terms related to this study

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Anxiety Disorders