Randomized, Controlled Trial of a Novel, Mechanistic Treatment for Anxiety in Young Children with ASD
Abstract
Study Rationale: Anxiety disorders affect 40% of young children, under 7 years of age, with autism. These disorders negatively affect autistic children because they may interfere with the child’s ability to participate in developmental treatments and increase the risk that a child will have anxiety or depression in adulthood. However, few studies have examined anxiety treatment for autistic children in this age range, and young autistic children with cognitive and language delays have been largely excluded from these trials. In school-age children with autism, cognitive-behavioral therapy (CBT) has been used successfully to reduce anxiety. CBT approaches may also reduce intolerance of uncertainty (IU), which is a specific type of fear in which children respond negatively to situations in which they do not know what is going to happen. In autistic children, IU is hypothesized to contribute to the emergence and maintenance of anxiety. This study seeks to address this gap in anxiety treatment by examining if a new, adapted CBT intervention, DINO Strategies for Anxiety and intolerance of Uncertainty Reduction (DINOSAUR), which targets both anxiety and IU, reduces anxiety in young autistic children. Objectives: Our study addresses three FY22 ARP Career Development Award Interest Areas: 1. Mechanisms underlying conditions co-occurring with autism: Our study targets IU, an underlying mechanism of anxiety in children with autism. 2. Improve diagnosis and access to services across the life span: We examine the efficacy of a novel intervention for a neglected age group in whom anxiety disorders are prevalent, young autistic children. 3. Understanding heterogeneity in treatment response: We include children with developmental delays (cognitive and language) and assess the association of these variables with treatment response. The study’s main goal is to examine the efficacy of a new treatment that targets both anxiety and IU, i.e., DINOSAUR, in young autistic children with varying cognitive and language levels. To accomplish this goal, we will investigate whether DINOSAUR is superior to an active control condition (parents only receive information about anxiety but are not taught specific anxiety management strategies) in reducing anxiety. We will also investigate whether DINOSAUR is superior to an active control in reducing IU. A secondary, exploratory goal is to understand how children’s language and cognitive level affect their response to anxiety treatment. We will also explore whether high IU levels before treatment contribute to higher anxiety after treatment. Seventy children, 4-6 years of age with autism and clinically significant anxiety and their parents will be randomly assigned to receive either the DINOSAUR or the active control (35 in each group) over 14 weeks via telehealth. Anxiety and IU will be assessed following treatment and at 4-month follow-up. Applicability and Impact: If, at the conclusion of our 3-year study, we show that DINOSAUR is better than the active control in reducing anxiety, it would provide the most compelling support to date regarding the potential efficacy of adapted CBT in reducing anxiety in young autistic children. It would also set the stage for a large-scale efficacy trial and the potential that DINOSAUR could become a viable anxiety treatment model disseminated to the larger autism community. Treating anxiety when autistic children are young may lead to lower anxiety levels across the child’s development and reduce the chance they will develop other psychiatric disorders across the lifespan. Having an effective anxiety treatment for young children may also encourage autism providers to screen for anxiety when children are young. Positive findings would also suggest that targeting IU in addition to anxiety may be helpful for children with autism and that future studies should study whether treating IU together with anxiety produces lower anxiety level
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Jan 04, 2024
- Source ID
- HT94252310587
Entities
People
- Amy Keefer
Organizations
- Kennedy Krieger Institute
- United States Army