DINO RCT - Treating Anxiety in Children With Autism

Phase

N/A

Condition

Williams Syndrome

Autism

Mood Disorders

Treatment

Psychoeducation

DINOSAUR

Clinical Study ID

NCT06066983

IRB00343724

CDMRP - AR220066

Ages 4-6
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 4 years 0 months to 6 years 11 months
DSM-5 ASD diagnosis based on clinical impressions and results of the AutismDiagnostic 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 EarlyLanguage 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

Exclusion Criteria:

Primary language other than English
Child is in foster care
Child displays severe behavior challenges that prevent participation in treatmentgroups (i.e., severe tantrums, aggression, or self-injury)
Participating parent experiencing active symptoms of substance abuse or severemental illness (i.e., schizophrenia, bipolar disorder)

Study Design

Psychoeducation

January 02, 2024

October 15, 2026

Study Description

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.

Connect with a study center

Kennedy Krieger Institute
Baltimore, Maryland 21211
United States
Active - Recruiting
Kennedy Krieger Institute
Baltimore 4347778, Maryland 4361885 21211
United States
Site Not Available

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