Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anxiety Disorders
  • Autism Spectrum Disorder
  • Cognitive Behavioral Therapy
  • Generalized Anxiety Disorder
  • Obsessive Compulsive Disorder
  • Social Anxiety Disorder
  • Specific Phobia
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Single group observational.Masking: None (Open Label)Masking Description: The rater is unaware of treatment status, that is if the child continues to receive treatment after Step 1 (versus being in maintenance).Primary Purpose: Treatment

Participation Requirements

Age
Between 4 years and 14 years
Gender
Both males and females

Description

Autism spectrum disorder (ASD) affects as many as 1 out of 59 individuals, with many higher-functioning youth not diagnosed until school-age or later. This equates to ~102,000 children under the age of 14 years in the state of Texas alone. Significant impairment in social and adaptive functioning ar...

Autism spectrum disorder (ASD) affects as many as 1 out of 59 individuals, with many higher-functioning youth not diagnosed until school-age or later. This equates to ~102,000 children under the age of 14 years in the state of Texas alone. Significant impairment in social and adaptive functioning are common, as are comorbid behavioral health disorders, with anxiety disorders affecting between 50-80% of youth with ASD. Given the relative frequency of anxiety disorders among children with ASD, the associated impairment, and worsening trajectory over time without intervention, there is a great need for treatment that specifically addresses anxiety-related symptoms in ASD. Cognitive-behavioral therapy (CBT) has been established as a first-line treatment for anxiety disorders among youth with and without ASD. A particular form of CBT, Behavioral Intervention for Anxiety in Children with ASD (BIACA), has demonstrated efficacy in a number of studies. However, treatment is delivered by therapists as "full-packages" (i.e., 12-16 clinic sessions), which can be therapist-intensive, costly, impractical for families, and not responsive to parental preferences. Alternatives approaches, such as parent-led, stepped-care models that improve accessibility, are efficient, provide personalized care, and lower mental health treatment cost, are greatly needed. Stepped-care models provide a lower-intensity first step (e.g., parent-led, less costly, and more convenient for parents) as the initial treatment with the assumption that a proportion of individuals will respond to the first step and others will need to step up to more intensive treatment. Matching treatment to families' needs and tailoring subsequent treatment may be an efficient and effective approach, as well as consistent with parents' desire to help their child. Given this, together with the substantial impairment associated with clinical anxiety in individuals with ASD across the age span, this study implements a parent-led, flexible, individually-tailored cognitive-behavioral intervention for children with ASD and anxiety.

Tracking Information

NCT #
NCT03720795
Collaborators
Not Provided
Investigators
Not Provided