Back to resultsDINO RCT - Treating Anxiety in Children With Autism
Primary Purpose
Autism Spectrum Disorder, Anxiety Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DINOSAUR
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
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)
Sites / Locations
- Kennedy Krieger Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Active Control
Arm Description
Parent-child dyads will receive DINOSAUR, a group-based cognitive-behavioral therapy (CBT) intervention, adapted for young children and delivered via telehealth. This 14 week intervention teaches parents and children strategies to reduce anxiety and intolerance of uncertainty, an underlying construct of anxiety.
Parents in the active control condition will participate in three psychoeducational groups focused on presenting information regarding anxiety prevalence, differentiating anxiety from autism, and anxiety triggers. These groups will be delivered via telehealth across a 14-week period.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT06066983
First Posted
September 28, 2023
Last Updated
September 28, 2023
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT06066983
Brief Title
DINO RCT - Treating Anxiety in Children With Autism
Official Title
Treating Anxiety in Young Children With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 15, 2026 (Anticipated)
Study Completion Date
October 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Anxiety Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Parent-child dyads will receive DINOSAUR, a group-based cognitive-behavioral therapy (CBT) intervention, adapted for young children and delivered via telehealth. This 14 week intervention teaches parents and children strategies to reduce anxiety and intolerance of uncertainty, an underlying construct of anxiety.
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
Parents in the active control condition will participate in three psychoeducational groups focused on presenting information regarding anxiety prevalence, differentiating anxiety from autism, and anxiety triggers. These groups will be delivered via telehealth across a 14-week period.
Intervention Type
Behavioral
Intervention Name(s)
DINOSAUR
Intervention Description
This intervention aims to treat intolerance of uncertainty and anxiety in young autistic children.
Intervention Type
Other
Intervention Name(s)
Psychoeducation
Intervention Description
This intervention provides psychoeducation regarding anxiety and autism.
Primary Outcome Measure Information:
Title
Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA)
Description
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 Outcome Measure Information:
Title
Change in anxiety severity on Child Behavior Checklist
Description
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-up
Title
Change in child's intolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale
Description
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-up
Title
Change on parental accommodating behaviors on Family Accommodation Scale following 14-week active control and 14-week intervention.
Description
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-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Nichols
Phone
667-205-4036
Email
NicholsN@kennedykrieger.org
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Keefer, PhD
Phone
443-923-7603
Email
keefer@kennedykrieger.org
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21211
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34635048
Citation
Keefer A, Vasa RA. DINOSAUR: an integrated cognitive-behavioral treatment for anxiety in young children with ASD. J Neurodev Disord. 2021 Oct 11;13(1):46. doi: 10.1186/s11689-021-09396-9.
Results Reference
result
PubMed Identifier
37350221
Citation
Vasa RA, Kerns CM, Singh V, McDonald R, Jang YS, Keefer A. Anxiety in autistic preschool children: Phenomenology and a network analysis of correlates. Autism Res. 2023 Aug;16(8):1561-1572. doi: 10.1002/aur.2968. Epub 2023 Jun 23.
Results Reference
result
Learn more about this trial
DINO RCT - Treating Anxiety in Children With Autism
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