Combined Effects of Early Behavioral Intervention and Propranolol on ASD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in General Social Outcome Measure (GSOM)
研究概览
简要总结
The purpose of this study is to explore the effects of propranolol in combination with early intensive behavioral intervention on social interaction, and secondarily on language, anxiety, adaptive behaviors, and global function in children with autism in a double-blinded, placebo-controlled pilot trial.
详细描述
The investigators' specific aim is to examine the effects of serial doses of propranolol in combination with early intensive behavioral intervention on social interaction, and secondarily on language tasks, anxiety, adaptive behaviors, and global function in children with autism in a double-blinded, placebo-controlled trial. The investigators will also examine whether response to treatment can be predicted based upon markers of autonomic functioning, such as pupillary light reflex and heart rate variability, and whether anxiety predicts treatment response. The investigators' hypothesis is that propranolol will augment the effects of behavioral therapy on social functioning and language abilities. The investigators have demonstrated benefits of propranolol on social functioning and language in previous single-dose studies in adults and adolescents with autism. The investigators also predict that those with the greatest degree of autonomic dysregulation will demonstrate the greatest benefit from the drug.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of autism spectrum disorder (ASD), defined in this study by the DSM-V criteria plus Autism Diagnostic Observation Schedule (ADOS) criteria for Autism.
- •Participants must also be enrolled in an early behavioral intervention program at the Thompson Center or another institution in Missouri for the duration of the study.
排除标准
- •Non-autism learning disability (e.g. dyslexia)
- •Major psychiatric diagnosis (e.g. major depression, schizophrenia, bipolar disorder)
- •Other neurological diagnosis
- •Major head trauma
- •Any of the following exclusionary criteria related to propranolol (diabetes, reactive airway/pulmonary disease, thyroid disease, bradyarrhythmias, unexplained syncope, narrow angle glaucoma, known hypersensitivity/adverse reaction to beta-blockers, potentially interacting drugs, underweight < 15 kg)
- •Any of the following exclusionary criteria related to the use of electrocardiogram (history of rash from adhesives)
- •Any of the following exclusionary criteria related to the pupillary reflex measurement (uncorrectable visual acuity impairment).
- •Participants with a heart rate of less than 60 or a systolic blood pressure of less than 75 at the outset of the study will be excluded.
研究组 & 干预措施
Propranolol arm
Propranolol will be administered in the form of a liquid dose via oral syringe by the participants' parent/caregiver an hour before each EIBI session. To minimize risk, the bodyweight adjusted minimum dose of propranolol used safely for test anxiety in healthy adults (10mg) will be used: participants weighing > 30 kg will be given 4 mg, participants weighing 22.5 - 30 kg will be given 3 mg, participants weighing 15 - 22.5 kg will be given 2 mg. Participants weighing < 15 kg will be excluded for safety reasons.
干预措施: Propranolol (Drug)
Placebo arm
Placebo will be administered in the form of a liquid dose via oral syringe by the participants' parent/caregiver an hour before each EIBI session.The same bodyweight adjusted doses specified in the propranolol arm will be used for this arm.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in General Social Outcome Measure (GSOM)
时间窗: Week 12
The GSOM is a brief evaluation tool that measures a participant's level of social functioning and how it changes with intervention. There GSOM includes 4 different tasks: conversational reciprocity, ability to recognize facial expressions, social problem solving, affect demonstration, and emotional perspective taking. The experimenter administers each component of the GSOM to the participant and then scores their responses according to a pre-determined scoring rubric. Each component is scored on a 1-5 or 0 - 2 scale, with higher total scores indicating better social functioning. A video camera will be used to record the participant's behavior during GSOM administration for the purposes of having two independent raters score the tasks after the study session is complete. A camera will also be used during the affect demonstration task of the GSOM. The overall score is used. The range is 6-132, with higher scores being better.
Change in Social Responsiveness Scale (SRS)
时间窗: Week 12
This 65-item, parent-report measure asks questions about a participants' social awareness, social information processing, capacity for reciprocal social responses, social anxiety or avoidance, and characteristic autistic preoccupations or traits. The total score is used with a range of 0-195, with lower scores being better.
次要结局
- Change in Preschool Anxiety Scale (PAS)(Week 12)
- Change in Aberrant Behavior Checklist (ABC)(Week 12)
- Change in Vineland Adaptive Behavior Scales-II (VABS)(Week 12)
- Change in Autism Impact Measure (AIM)(Week 12)
- Change in Preschool Language Scale (PLS):(Week 12)
研究者
David Beversdorf
Associate Professor, Radiology, Neurology, Psychology
University of Missouri-Columbia