Back to resultsAnxiety Intervention for Preschool Children With ASD
Primary Purpose
Anxiety Disorder, Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorder
Eligibility Criteria
Inclusion Criteria:
- Age 4 years 0 months to 6 years 11 months
- NVIQ ≥ 85 based on Mullen Scales of Early Learning or Stanford Binet 5
- Expressive and Receptive Language scores ≥ 85 based on Preschool Language Scale - Fifth Edition or Orals or Written Language Scales, Second Edition
- DSM-5 diagnoses of Separation Anxiety, Social Anxiety, and/or Generalized Anxiety Disorder and/or the distinct diagnosis of Other Social Fear based on the results of the Anxiety Disorders Interview Schedule/ASA
Exclusion Criteria:
- History of psychological trauma
- History of neurologic illness
- Parent substance abuse, bipolar disorder, psychosis
- Parents require support from a medical interpreter
- Child displays severe behavior challenges
- Severe eyesight or hearing impairments that may interfere with the protocols
- Child's behavior prevents their ability to participate in a 1 hour group consisting of various activities (e.g., listening to a story, snacks, playing movement games, completing a craft)
Sites / Locations
- Kennedy Krieger Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
All participants receive the DINOSAUR intervention
Outcomes
Primary Outcome Measures
Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA) after 12-week waitlist and 12-week intervention
clinician administered, semi-structured interview assessing anxiety disorders; clinical severity ratings range from 0 to 3 or 0 to 8; higher scores indicate more impairment
Improvement in child anxiety symptoms on Clinical Global Impressions Scale-Improvement following 12-week intervention
used to assess treatment response; scores range from 1 (very much improved) to 7 (very much worse)
Secondary Outcome Measures
Change in child anxiety symptoms on Preschool Anxiety Scale - Revised following 12-week waitlist and 12-week intervention
parent and teacher report scale measuring levels of anxiety in preschool aged children; scores range from 0 to 112; higher scores indicate higher anxiety
Change in child anxiety symptoms on the Screen for Child Anxiety Related Disorders following 12-week waitlist and 12-week intervention
parent and teacher report scale measuring levels of anxiety in children older than 5 years old; scores range from 0 to 114; higher scores indicate higher anxiety
Change in severity of anxiety and other psychiatric symptoms on Child Behavior Checklist following 12-week waitlist and 12-week intervention
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 tolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale following 12-week waitlist and 12-week intervention
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 in child ASD symptoms on Social Responsiveness Scale following 12-week waitlist and 12-week intervention
parent report scale that assesses the presence and severity of social impairment in children; T-scores range from 20 to 100; higher scores indicate higher ASD severity
Change in child repetitive behaviors on Repetitive Behavior Scale-Revised following 12-week waitlist and 12-week intervention
parent-report measure of repetitive behavior in children with ASD; scores range from 0 to 176; higher scores indicate greater impairment
Change in parental anxiety and depression symptoms on Hospital Anxiety and Depression Scale following 12-week waitlist and 12-week intervention
parental screening tool that captures clinical anxiety and depression; scores range from 0 to 21; higher scores indicate higher anxiety and/or depression symptoms
Change in parental tolerance of uncertainty on Intolerance of Uncertainty Scale following 12-week waitlist and 12-week intervention
parental scale that measures responses to uncertainty, ambiguous situations and the future; scores range from 12 to 60; higher scores indicate higher intolerance of uncertainty
Change on parental accommodating behaviors on Family Accommodation Scale following 12-week waitlist and 12-week intervention
assesses parental accommodating behaviors; scores range from 0 to 36; higher scores indicate higher parental accommodation
Change in child attention bias to threat on Behavioral Paradigms following 12-week waitlist and 12-week intervention
eye tracking paradigms used to assess attention bias to threat; more frequent saccades to threatening stimuli indicate higher attention bias to threat
Full Information
NCT ID
NCT04432077
First Posted
June 3, 2020
Last Updated
October 12, 2022
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Organization for Autism Research
1. Study Identification
Unique Protocol Identification Number
NCT04432077
Brief Title
Anxiety Intervention for Preschool Children With ASD
Official Title
Piloting an Integrated Anxiety Intervention for Preschool Children With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
Organization for Autism Research
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
This study evaluates the feasibility, acceptability, and preliminary efficacy of a treatment program for anxiety in preschool children with autism spectrum disorder.
Detailed Description
Anxiety is highly prevalent in individuals with ASD with lifelong impact. In this population, anxiety often emerges when children are very young, yet there are no evidence-based treatments for this age group. Cognitive-behavioral treatment (CBT) successfully reduces anxiety levels in young, typically developing children and older children with ASD. This study pilots the DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR) program, which is an integrated treatment program that utilizes CBT modified for young children with ASD. The treatment includes heavy doses of parent training to reduce accommodation of the child's anxiety symptoms and interventions targeting fear of uncertainty, a common fear in children with ASD. The feasibility, acceptability, and preliminary efficacy of this treatment program will be studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
All participants receive the DINOSAUR intervention
Intervention Type
Behavioral
Intervention Name(s)
DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)
Intervention Description
DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR) - a parent-mediated cognitive-behavioral treatment modified for young children with ASD
Primary Outcome Measure Information:
Title
Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA) after 12-week waitlist and 12-week intervention
Description
clinician administered, semi-structured interview assessing anxiety disorders; clinical severity ratings range from 0 to 3 or 0 to 8; higher scores indicate more impairment
Time Frame
Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week treatment (pre-treatment to post-treatment)
Title
Improvement in child anxiety symptoms on Clinical Global Impressions Scale-Improvement following 12-week intervention
Description
used to assess treatment response; scores range from 1 (very much improved) to 7 (very much worse)
Time Frame
Following 12-week intervention (post-treatment)
Secondary Outcome Measure Information:
Title
Change in child anxiety symptoms on Preschool Anxiety Scale - Revised following 12-week waitlist and 12-week intervention
Description
parent and teacher report scale measuring levels of anxiety in preschool aged children; scores range from 0 to 112; higher scores indicate higher anxiety
Time Frame
Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
Title
Change in child anxiety symptoms on the Screen for Child Anxiety Related Disorders following 12-week waitlist and 12-week intervention
Description
parent and teacher report scale measuring levels of anxiety in children older than 5 years old; scores range from 0 to 114; higher scores indicate higher anxiety
Time Frame
Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
Title
Change in severity of anxiety and other psychiatric symptoms on Child Behavior Checklist following 12-week waitlist and 12-week intervention
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 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
Title
Change in child's tolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale following 12-week waitlist and 12-week intervention
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 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
Title
Change in child ASD symptoms on Social Responsiveness Scale following 12-week waitlist and 12-week intervention
Description
parent report scale that assesses the presence and severity of social impairment in children; T-scores range from 20 to 100; higher scores indicate higher ASD severity
Time Frame
Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
Title
Change in child repetitive behaviors on Repetitive Behavior Scale-Revised following 12-week waitlist and 12-week intervention
Description
parent-report measure of repetitive behavior in children with ASD; scores range from 0 to 176; higher scores indicate greater impairment
Time Frame
Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
Title
Change in parental anxiety and depression symptoms on Hospital Anxiety and Depression Scale following 12-week waitlist and 12-week intervention
Description
parental screening tool that captures clinical anxiety and depression; scores range from 0 to 21; higher scores indicate higher anxiety and/or depression symptoms
Time Frame
Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
Title
Change in parental tolerance of uncertainty on Intolerance of Uncertainty Scale following 12-week waitlist and 12-week intervention
Description
parental scale that measures responses to uncertainty, ambiguous situations and the future; scores range from 12 to 60; higher scores indicate higher intolerance of uncertainty
Time Frame
Before and after 12-week wailist (baseline to pre-treatment); Before and after 12-week intervention
Title
Change on parental accommodating behaviors on Family Accommodation Scale following 12-week waitlist and 12-week intervention
Description
assesses parental accommodating behaviors; scores range from 0 to 36; higher scores indicate higher parental accommodation
Time Frame
Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
Title
Change in child attention bias to threat on Behavioral Paradigms following 12-week waitlist and 12-week intervention
Description
eye tracking paradigms used to assess attention bias to threat; more frequent saccades to threatening stimuli indicate higher attention bias to threat
Time Frame
Before and after 12-week waitlist (pre-treatment to post-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
48 Months
Maximum Age & Unit of Time
83 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 4 years 0 months to 6 years 11 months
NVIQ ≥ 85 based on Mullen Scales of Early Learning or Stanford Binet 5
Expressive and Receptive Language scores ≥ 85 based on Preschool Language Scale - Fifth Edition or Orals or Written Language Scales, Second Edition
DSM-5 diagnoses of Separation Anxiety, Social Anxiety, and/or Generalized Anxiety Disorder and/or the distinct diagnosis of Other Social Fear based on the results of the Anxiety Disorders Interview Schedule/ASA
Exclusion Criteria:
History of psychological trauma
History of neurologic illness
Parent substance abuse, bipolar disorder, psychosis
Parents require support from a medical interpreter
Child displays severe behavior challenges
Severe eyesight or hearing impairments that may interfere with the protocols
Child's behavior prevents their ability to participate in a 1 hour group consisting of various activities (e.g., listening to a story, snacks, playing movement games, completing a craft)
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
27405445
Citation
Keefer A, Kreiser NL, Singh V, Blakeley-Smith A, Duncan A, Johnson C, Klinger L, Meyer A, Reaven J, Vasa RA. Intolerance of Uncertainty Predicts Anxiety Outcomes Following CBT in Youth with ASD. J Autism Dev Disord. 2017 Dec;47(12):3949-3958. doi: 10.1007/s10803-016-2852-z.
Results Reference
background
PubMed Identifier
29504790
Citation
Reaven J, Moody EJ, Grofer Klinger L, Keefer A, Duncan A, O'Kelley S, Meyer A, Hepburn S, Blakeley-Smith A. Training clinicians to deliver group CBT to manage anxiety in youth with ASD: Results of a multisite trial. J Consult Clin Psychol. 2018 Mar;86(3):205-217. doi: 10.1037/ccp0000285.
Results Reference
background
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
derived
Learn more about this trial
Anxiety Intervention for Preschool Children With ASD
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