Translational Biomarkers and Therapeutic Development for Very Young Children Diagnosed With Autism Spectrum Disorder and Co-occurring Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Spence Preschool Anxiety Scale (SPAS) or Spence Anxiety Scale (SCAS) Parent Report
研究概览
简要总结
A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).
详细描述
A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).
The main questions the study aims to answer are:
- To evaluate the stability of each potential biomarker over a 3-4-week retest period. The biomarkers are hypothesized to have adequate stability (ICC: > .5) in the absence of intervention.
- To determine which baseline biomarker scores predict response to a manualized cognitive behavioral therapy (CBT) program for treating anxiety, Being Brave.
- To determine which biomarkers are sensitive to treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 3;0 and 6;11 years old
- •A diagnosis of autism spectrum disorder using DSM-5 diagnostic criteria
- •A diagnosis of anxiety disorder using DSM-5 diagnostic criteria
- •Use of fluent 2-3 word phrases or fluent speech (i.e., Module 2 or 3 for ADOS-2)
- •Cognitive ability (either verbal or non-verbal IQ) > 80 using the DAS-2
- •A parent/guardian who is willing/able to participate and respond to interviews/surveys in English and willing/able to participate in Being Brave parent training in English and support homework activities.
排除标准
- •Presence of seizures
- •Premature birth (<36 weeks) or low birth weight (<2500 gms)
- •Known genetic or medical disorders (e.g., Fragile X), or injuries (e.g., stroke) with implications for the nervous system or that require regular psychoactive medication that alter EEG/RSA/EDR signal (e.g., anti-convulsants)
- •Significant sensory or motor impairment (e.g., blindness)
- •Major physical abnormalities
- •Exposure to environmental factors that could contribute to neurocognitive delays (significant alcohol exposure in utero, extreme environmental deprivation)
- •Previous CBT for anxiety
- •Presence of conduct or oppositional defiant disorder or ADHD so severe as to interfere with the child's ability to take part in treatment
- •Presence of a primary presenting problem for which the intervention would be inappropriate (e.g., obsessive-compulsive disorder, severe mood disorder, suicidality)
- •Psychotic symptoms in the child or parents
- •Parent/caregiver who is not fluent in English or English is spoken in the home less than half of the time.
研究组 & 干预措施
Intervention Group
Being Brave
干预措施: Being Brave (Behavioral)
结局指标
主要结局
Spence Preschool Anxiety Scale (SPAS) or Spence Anxiety Scale (SCAS) Parent Report
时间窗: At baseline enrollment visit and post intervention approximately 20 weeks later
Parents of children ages 3 to 5 will complete the SPAS and parents of 6 year old children will complete the SCAS. These are questionnaires designed to assess the severity of anxiety symptoms in preschool-aged and school-aged children. Scores range from 0-136 with higher scores indicating greater anxiety.
次要结局
- Behavior Assessment System for Children (BASC-3)(At baseline enrollment visit and post intervention approximately 20 weeks later)
- Pediatric Anxiety Rating Scale (PARS)(At baseline enrollment visit and post intervention approximately 20 weeks later)
- Clinical Global Impression of Anxiety (CGI-A) Interview(At baseline enrollment visit and post intervention approximately 20 weeks later)
研究者
Susan Faja
Associate Professor
Boston Children's Hospital