Treating Anxiety in Young Children With Autism

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Anxiety is prevalent in young children, under 7 years of age, with autism. Yet, few studies have examined anxiety interventions for this age range, and only one anxiety treatment study has included young children with cognitive and language delays. Anxiety treatment models utilizing cognitive-behavioral therapy (CBT), adapted for children with autism, are empirically supported in school-age autistic children. Further, preliminary evidence suggests CBT approaches may reduce intolerance of uncertainty (IU), a mechanistic construct that may contribute to the maintenance of anxiety in autistic children. This study seeks to address the existing gap in anxiety treatment by examining the feasibility and preliminary efficacy of a novel, telehealth CBT intervention, DINO Strategies for Anxiety and intolerance of Uncertainty Reduction (DINOSAUR), which targets both anxiety and IU in young autistic children.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 6
Healthy Volunteers: t
View:

• Age 4 years 0 months to 6 years 11 months

• DSM-5 ASD diagnosis based on clinical impressions and results of the Autism Diagnostic Observation Schedule-2 (ADOS-2)

• CBCL Anxiety Problems T-score \> 65

• SB-5 ABIQ \> 60

• Receptive and expressive language age equivalent \> 36 months based on Test of Early Language Development, Fourth Edition (TELD-4)

• Parent (or other caregiver) available and willing to attend 14-week intervention

• Absence of identifiable neurological (e.g., epilepsy), genetic (e.g., Down syndrome, fragile X, tuberous sclerosis, neurofibromatosis) or severe sensory-motor (e.g., severe vision impairment) conditions

• Able to walk independently (a requirement for ADOS-2)

Locations
United States
Maryland
Kennedy Krieger Institute
RECRUITING
Baltimore
Contact Information
Primary
Belina Onomake
OnomakeB@kennedykrieger.org
667-205-4036
Backup
Amy Keefer, PhD
keefer@kennedykrieger.org
443-923-7603
Time Frame
Start Date: 2024-01-02
Estimated Completion Date: 2026-10-15
Participants
Target number of participants: 70
Treatments
Experimental: Treatment
Parent-child dyads will receive DINOSAUR, a group-based cognitive-behavioral therapy (CBT) intervention, adapted for young children and delivered via telehealth. This 14 week intervention teaches parents and children strategies to reduce anxiety and intolerance of uncertainty, an underlying construct of anxiety.
Active_comparator: Active Control
Parents in the active control condition will participate in three psychoeducational groups focused on presenting information regarding anxiety prevalence, differentiating anxiety from autism, and anxiety triggers. These groups will be delivered via telehealth across a 14-week period.
Related Therapeutic Areas
Sponsors
Leads: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

This content was sourced from clinicaltrials.gov