Anxiety Intervention for Preschool Children With ASD

NCT04432077 | Completed

• 1 other identifier: 2019A06
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety Disorder; Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Change in child anxiety symptoms on Preschool Anxiety Scale - Revised following 12-week waitlist and 12-week intervention

  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

  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

  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

  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

  Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)

Study Arms (1)

Treatment

EXPERIMENTAL

All participants receive the DINOSAUR intervention

Behavioral: DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)

Interventions

DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR) BEHAVIORAL

DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR) - a parent-mediated cognitive-behavioral treatment modified for young children with ASD

Treatment

Eligibility Criteria

• Age: 48 Months - 83 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

Related Publications (3)

• 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.

  PMID: 27405445 BACKGROUND

• 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.

  PMID: 29504790 BACKGROUND

• 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.

  PMID: 34635048 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 16, 2020
• Study Start: October 12, 2020
• Primary Completion: July 31, 2022
• Study Completion: October 1, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)