Anxiety Intervention for Preschool Children With ASD

Piloting an Integrated Anxiety Intervention for Preschool Children With Autism Spectrum Disorder

This study evaluates the feasibility, acceptability, and preliminary efficacy of a treatment program for anxiety in preschool children with autism spectrum disorder.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder; Anxiety Disorder
• Intervention / Treatment: Behavioral: DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21211
      • Kennedy Krieger Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; All participants receive the DINOSAUR intervention	Behavioral: DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR); DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR) - a parent-mediated cognitive-behavioral treatment modified for young children with ASD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week treatment (pre-treatment to post-treatment)
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)	Following 12-week intervention (post-treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
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	Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
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	Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
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	Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
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	Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
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	Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
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	Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
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	Before and after 12-week wailist (baseline to pre-treatment); Before and after 12-week intervention
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	Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
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	Before and after 12-week waitlist (pre-treatment to post-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)

Collaborators and Investigators

• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Collaborators: Organization for Autism Research

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Disease; Anxiety Disorders; Autism Spectrum Disorder
• Other Study ID Numbers: 2019A06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No