DINO RCT - Treating Anxiety in Children With Autism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
DINOSAUR
BehavioralThis intervention aims to treat intolerance of uncertainty and anxiety in young autistic children.
Psychoeducation
Other interventionThis intervention provides psychoeducation regarding anxiety and autism.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: Active ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA)
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.
Time frame
Before and after 14-week treatment (baseline to post-treatment)Secondary outcomes
1
Change in anxiety severity on Child Behavior Checklist
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.
Time frame
Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up2
Change in child's intolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale
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.
Time frame
Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up3
Change on parental accommodating behaviors on Family Accommodation Scale following 14-week active control and 14-week intervention.
Assesses parental accommodating behaviors; scores range from 0 to 36; higher scores indicate higher parental accommodation.
Time frame
Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-upSponsors and contacts
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Source ClinicalTrials.gov