Study to Evaluate and Explore Scales for Repetitive and Restricted Behaviors and Digital Biomarkers in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 18
- 主要终点
- Children's Yale-Brown Obsessive Compulsive Scale Modified for Autism Spectrum Disorder (CY-BOCS-ASD) - Total Score
研究概览
简要总结
This is a non-drug study seeking to characterize different scales to measure repetitive and restrictive behaviors in different ASD sub-populations over time. This study will also explore the use of digital biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for All Participants
- •Males and females
- •Availability of a parent or other reliable caregiver. The same person must agree to accompany the participant to all clinic visits and provide information about the participant's behavior and symptoms
- •Inclusion Criteria for Participants with Autism Spectrum Disorders (ASD)(Diagnostic evaluations will be completed at study site by research staff and supervised by a licensed psychologist)
- •Age: 5-45 years
- •Diagnosis of ASD based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), and the Autism Diagnostic Observation Schedule (ADOS-2).
- •Children's Yale-Brown Obsessive Compulsive Scale modified for ASD (CY-BOCS-ASD) total score of at least 12
- •Clinical Global Impression-Severity (CGI-S) scale of at least 4 about participant's current autism severity
- •Intelligence quotient (IQ) score of 50 or above as assessed by the Abbreviated Intelligence Quotient (ABIQ) SB5 scale
- •All medications and treatments are expected to be stable for the duration of the study
- •Inclusion Criteria for Typically Developing (TD) Healthy Participants
- •TD participants aged 5-45 years
排除标准
- •for All Participants
- •Participation in an in investigational drug or device study within 4 weeks or 5 times the half-life of the investigational molecule prior to screening, and participant is not expected to enroll in any other trial during the study
- •Co-occurring disease, condition, or treatment that might interfere with the conduct of the study or pose an unacceptable risk to the participant
- •Unstable or uncontrolled clinically significant psychiatric and/or neurological disorder that may interfere with study objectives
- •Exclusion Criteria for Participants with ASD -Known "syndromic" ASD (e.g. Fragile X syndrome, Angelman syndrome, Prader-Willi, Rett's syndrome, tuberous sclerosis, Dup15q syndrome) History of alcohol misuse and/or illicit drug use during the last 12 months of the study
- •Exclusion Criteria for TD Healthy Participants
- •TD healthy participants with a first-degree relative with ASD
研究组 & 干预措施
Typically Developing (TD) Healthy Participant Children
Participants will be 5-12 years old
TD Healthy Participant Adolescents
Participants will be 13-17 years old
TD Healthy Participant Adults
Participants will be 18-45 years old
High-Functioning ASD Adults
Participants will be 18-45 years old, with IQ scores of 70 or above
干预措施: No Intervention (Other)
Low-Functioning ASD Adults
Participants will be 18-45 years old, with IQ scores between 50-70
干预措施: No Intervention (Other)
High-Functioning ASD Adolescents
Participants will be 13-17 years old, with IQ scores of 70 or above
干预措施: No Intervention (Other)
Low-Functioning ASD Adolescents
Participants will be 13-17 years old, with IQ scores between 50-70
干预措施: No Intervention (Other)
High-Functioning ASD Children
Participants will be 5-12 years old, with IQ scores of 70 or above
干预措施: No Intervention (Other)
Low-Functioning Autism Spectrum Disorder (ASD) Children
Participants will be 5-12 years old, with Intelligence Quotient (IQ) scores between 50-70
干预措施: No Intervention (Other)
结局指标
主要结局
Children's Yale-Brown Obsessive Compulsive Scale Modified for Autism Spectrum Disorder (CY-BOCS-ASD) - Total Score
时间窗: Baseline, Weeks 2 and 12
The CY-BOCS-ASD is where the interviewer asks the parent/caregiver about past and present repetitive behaviors, guided by the revised repetitive behavior checklist with a list of 25 behaviors, classified into the following categories: Hoarding/ritualistic behavior, Sensorymotor and arranging, Insistence on routines /Self-injurious behaviors, Stereotypy and Restricted interests. This checklist was expanded to include repetitive behaviors commonly seen in children with ASD. A target symptom list comprising the four most troublesome behaviors is established by the interviewer. The severity (0 to 4) of each target behavior is rated for the following five items: time spent, interference, distress, resistance and degree of control to generate a total score (0-20). The ratings evaluate the symptom severity over the past week and are based on the information collected from the child and parent/caregiver during the interview. Values at visits are reported.
Repetitive Behavior Scale-Revised (RBS-R)
时间窗: Baseline, Weeks 2 and 12
The Repetitive Behavior Scale-Revised (RBS-R) is a 43-item caregiver-report questionnaire to measure breadth of repetitive behaviors in children, adolescents, and adults with ASD. It provides a quantitative measure of the full spectrum of repetitive behaviors of 6 subscales: Stereotype, Self-injurious, Compulsive, Ritualistic, Sameness and Restricted Behaviors. Caregivers are asked to read a list of behaviors and choose for each item a score that best describes how much of a problem the behavior has been over the last month. Behaviors are rated on a 4-point scale: 0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem. The total score is the sum of all 43 items and can range from 0 to 129. Higher scores indicate more severe problems with repetitive behaviors. The sums of score values at visits are reported.
Repetitive Behavior Questionnaire for Children (RBQ-2)
时间窗: Baseline, Weeks 2 and 12
The RBQ-2 is a 20 items questionnaire to assess the spectrum of restricted and repetitive behaviors observed in individuals with ASD such as repetitive motor movements, rigidity/adherence to routine, preoccupation with restricted patterns of interest and unusual sensory Interest (Leekman et al 2007; Honey et al 2012). The RBQ-2 exists in two different versions, a caregiver reported version for pediatric subjects RBQ-2 and a participant-reported version for adults RBQ-2A (Barrett et al 2015). The RBQ-2, the caregiver version is used for this reported data set. To ensure for this study a comparable the mean total score is calculated as the sum of the items, total scores at visits are reported. For the RBQ-2, the possible total score can range between 20-60, with higher scores indicating more frequent RRB.
Restricted Behavior Questionnaire for Adults (RBQ-2A)
时间窗: Baseline, Weeks 2 and 12
The RBQ-2 is a 20 items questionnaire to assess the spectrum of restricted and repetitive behaviorsobserved in individuals with ASD such as repetitive motor movements, rigidity/adherence to routine, preoccupation with restricted patterns of interest and unusual sensory Interest (Leekman et al 2007; Honey et al 2012). The RBQ-2 exists in two different versions, a caregiver reported version for pediatric subjects RBQ-2 and a participant-reported version for adults RBQ-2A (Barrett et al 2015). The RBQ-2, the caregiver version is used for this reported data set. Total score is calculated as the sum of the items, total scores at visits are reported. For the RBQ-2A, the possible total score can range between 20 to 60, with higher scores indicating more frequent and severe RRB.
Adult Routines Inventory (ARI)
时间窗: Baseline, Weeks 2 and 12
The CRI-R (for children and Adolescents) and ARI (for adults) were developed together and are closely related scales (Evans et al 2017).The CRI-R and ARI questionnaires capture a wide range of RRBs, including stereotypies, tics, compulsions, habits, sensory sensitivities, and focused interests, in the context of typical and atypical development in children, adolescents and adults across the entire lifespan. All items will be answered on a five-point Likert scale from not at all/ never, a little/rarely, somewhat/ sometimes, quite a lot/ often, and very much / always. The caregiver-completed CRI-R scale for pediatric subjects includes 62 items. The participant-reported ARI scale for adult subjects includes 55 items and will be completed by the participant. Total score is calculated as the sum of the items, mean total scores at visits are reported. For the ARI, the possible total score can range between 55-275, with higher scores indicating more frequent RRB.
Montefiore Einstein Rigidity Scale (MERS-R)
时间窗: Baseline, Weeks 2 and 12
The MERS-R was to assess 3 domains of rigid behavior in children and adults. It's a clinician-administered scale in which the clinician uses all available information to rate. Each domains is assessed separately, during examples are discussed and related behaviors are probed for more individualized exemplars. A list of relevant behaviors is compiled for each domain, and ratings for the items are based on the average occurrence of the behaviors over the past one week. Total values at visits are reported and domains are assessed: ASD: 1. Behavioral Rigidity (e.g., insistence on sameness, things must be done in his/her way) 2. Cognitive Rigidity (e.g., inflexible adherence to rules) 3. Protest (in response to deviation from rigidity; e.g., verbal objection, tantrum, physical aggression). These domain scores can range from 0 (no problems) to 4 (severe problems). The total score represents the sum of the domain scores ranging from 0-48, where higher scores indicate more severe problems.
Childhood Routines Inventory-Revised (CRI-R)
时间窗: Baseline, Weeks 2 and 12
The CRI-R (for children and adolescents) and ARI (for adults) were developed together and are closely related scales (Evans et al 2017).The CRI-R and ARI questionnaires capture a wide range of restricted and repetitive behaviors, including stereotypies, tics, compulsions, habits, sensory sensitivities, and focused interests, in the context of typical and atypical development in children, adolescents and adults across the entire lifespan. All items will be answered on a five-point Likert scale from not at all/ never, a little/rarely, somewhat/ sometimes, quite a lot/ often, and very much / always. The caregiver-completed CRI-R scale for pediatric subjects includes 62 items. Total score is calculated as the sum of the items, total scores at visits are reported. For the CRI-R, the possible total score can range between 62 - 310, with higher scores indicating more frequent RRB.
次要结局
- Child's Sleep Habits Questionnaire (CSHQ)(Baseline, Weeks 2 and 12)
- Clinical Global Impression Scales (CGI)(Baseline, Weeks 2 and 12)
- Reading the Mind in the Eyes Test Child -C (RMET-C)(Baseline, Week 12)
- Pittsburg Sleep Quality Index (PSQI)(Baseline, Weeks 2 and 12)
- Beck Anxiety Index (BAI)(Baseline, Weeks 2 and 12)
- Digital Biomarkers(Baseline until study completion (approximately 12 weeks))
- Reading the Mind in the Eyes Test -R (RMET-R)(Baseline, Week 12)
- Hamilton Anxiety Rating Scale (HAM-A)(Baseline, Weeks 2 and 12)
- Parent Rated Anxiety Scale for ASD (PRAS-ASD)(Baseline, Weeks 2 and 12)
- Behaviour Rating Inventory of Executive Function for Children (BRIEF)(Baseline, Weeks 2 and 12)
- Behaviour Rating Inventory of Executive Function for Adults (BRIEF-A)(Baseline, Weeks 2 and 12)
- Short Sensory Profile (SSP)(Baseline, Weeks 2 and 12)
- Pediatric Quality of Life Inventory (PedsQL) Family Impact Scale(Baseline, Weeks 2 and 12)
- PedsQL Core Functioning Scale(Baseline, Weeks 2 and 12)
- PedsQL Cognitive Functioning Scale(Baseline, Week 2 and 12)
- Vineland(TM)-II Survey(Baseline, Week 12)