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Anxiety Intervention for Preschool Children With ASD

H

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Status

Completed

Conditions

Autism Spectrum Disorder
Anxiety Disorder

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04432077
2019A06

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

All

Ages

48 to 83 months old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Treatment
Experimental group
Description:
All participants receive the DINOSAUR intervention
Treatment:
Behavioral: DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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