Treating Anxiety in Young Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA)
研究概览
简要总结
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.
详细描述
The purpose of this study is to examine the feasibility and preliminary 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 if DINOSAUR is a feasible intervention for families of young autistic children. We will also investigate if DINOSAUR is superior to an active control condition in reducing anxiety and IU. A third, exploratory goal is to understand how children's language and cognitive level affect their response to anxiety treatment. Seventy children, 4-6 years of age with autism and clinically significant anxiety, and their parents will be randomly assigned to receive either DINOSAUR or the active control (35 in each group) over 14 weeks via telehealth. Within each condition, children will be stratified based on cognitive level. Anxiety and IU will be assessed following treatment and at 4-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Primary language other than English
- •Child is in foster care
- •Child displays severe behavior challenges that prevent participation in treatment groups (i.e., severe tantrums, aggression, or self-injury)
- •Participating parent experiencing active symptoms of substance abuse or severe mental illness (i.e., schizophrenia, bipolar disorder)
研究组 & 干预措施
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.
干预措施: DINOSAUR (Behavioral)
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.
干预措施: Psychoeducation (Other)
结局指标
主要结局
Change in child anxiety diagnostic status on Anxiety Disorders Interview Schedule, Autism Spectrum Disorder Addendum (ADIS-ASA)
时间窗: Before and after 14-week treatment (baseline to post-treatment)
The Anxiety Disorders Interview Schedule (ADIS) is a semi-structured parent interview assessing the severity of anxiety disorders and its presentation in individuals with autism.
次要结局
- Change in anxiety severity on Child Behavior Checklist(Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up)
- Change in child's intolerance of uncertainty on Response to Uncertainty and Low Environmental Stability Scale(Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up)
- Change on parental accommodating behaviors on Family Accommodation Scale following 14-week active control and 14-week intervention.(Before and after 14-week treatment (baseline to post-treatment) and at 4 month follow-up)
研究者
Amy Keefer
Principal Investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.