Clinical trial NCT04432077: Anxiety Intervention for Preschool Children With ASD
Official title: Piloting an Integrated Anxiety Intervention for Preschool Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Autism Spectrum Disorder
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: Organization for Autism Research
First posted: 2020-06-16
Enrollment: 12
Sex: ALL
Minimum age (years): 48
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: 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
timeFrame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week treatment (pre-treatment to post-treatment)
measure: Improvement in child anxiety symptoms on Clinical Global Impressions Scale-Improvement following 12-week intervention
timeFrame: Following 12-week intervention (post-treatment)
Secondary outcomes:
measure: Change in child anxiety symptoms on Preschool Anxiety Scale - Revised following 12-week waitlist and 12-week intervention
timeFrame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
measure: Change in child anxiety symptoms on the Screen for Child Anxiety Related Disorders following 12-week waitlist and 12-week intervention
timeFrame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
measure: Change in severity of anxiety and other psychiatric symptoms on Child Behavior Checklist following 12-week waitlist and 12-week intervention
timeFrame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
measure: Change in child's tolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale following 12-week waitlist and 12-week intervention
timeFrame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
measure: Change in child ASD symptoms on Social Responsiveness Scale following 12-week waitlist and 12-week intervention
timeFrame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
measure: Change in child repetitive behaviors on Repetitive Behavior Scale-Revised following 12-week waitlist and 12-week intervention
timeFrame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
measure: Change in parental anxiety and depression symptoms on Hospital Anxiety and Depression Scale following 12-week waitlist and 12-week intervention
timeFrame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
measure: Change in parental tolerance of uncertainty on Intolerance of Uncertainty Scale following 12-week waitlist and 12-week intervention
timeFrame: Before and after 12-week wailist (baseline to pre-treatment); Before and after 12-week intervention
measure: Change on parental accommodating behaviors on Family Accommodation Scale following 12-week waitlist and 12-week intervention
timeFrame: Before and after 12-week waitlist (baseline to pre-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
measure: Change in child attention bias to threat on Behavioral Paradigms following 12-week waitlist and 12-week intervention
timeFrame: Before and after 12-week waitlist (pre-treatment to post-treatment); Before and after 12-week intervention (pre-treatment to post-treatment)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
References:
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.
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.
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.