Early Recognition and Intervention in Siblings at High-risk for Neurodevelopmental Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Communication and Symbolic Behaviour Scales - Infant-Toddler Checklist (CSBS-IT-C)
研究概览
简要总结
H1The primary goal of this intervention study is to learn if very early parent-mediated intervention in children at risk for neurodevelopmental disorders in the first year of life can be implemented in routine care, positively impacting early sensory-motor and socio-communicative developmental trajectories and reducing the developmental gap in children with signs of concern.
H2: It is here postulated that early intervention with active parental involvement can reduce parental stress, as well as improve parental understanding and responsiveness to the child's communication cues.
H3: An important part of our work will be analysing data about early social and joint attention behaviours in recruited children and comparing them at different time points. The hypothesis is to find early differences between groups at baseline and to detect a change before and after the intervention. For this reason, in our study design, we decided to use technologies to collect data on quantitative measures during play-structured and laboratory sessions to understand changes in developmental trajectories.
H4: Given the potential role of genetic and immunological mechanisms in ASD, one of the study's secondary aims is to investigate the impact of an early intervention programme on epigenetic changes and inflammatory and immune response.
After enrolment and baseline assessments (T0), children will be allocated to the three groups:
- Group 1 - Clinical Monitoring Group (CM): Siblings of TD children subjects with no signs of concern
- Group 2 - Active Monitoring Group (AM): Siblings of ASD children with no signs of concern
- Group 3 - Early Intervention Group (EI): Siblings classified as "with signs of concern" at baseline evaluation.
All children will be re-evaluated after 6 months (T1) and after 12 months (T2).
详细描述
Researchers will contact interested parents to assess eligibility and provide detailed study information. Parents will provide written consent before completing baseline assessments (T0) and based on the scores at the main outcome measures, children will be assigned to the correct group. Infants with no signs of concern and siblings of TD children will be allocated to Group 1 (CM); infants with no signs of concern (scores at the Griffiths-3 and CSBS-ITC in the normal range) and siblings of ASD children will be allocated to Group 2 (AM); infants with General Quotient score below 85 using Griffiths-3 and/or at least one score above the "concern" cutoff using the CSBS-ITC will be allocated to Group 3 (EI). Families allocated to Groups 2 and 3 will start the intervention within one month from the baseline assessment. Families allocated to Group 1 will perform only the evaluations at different time points. Assessments will be conducted at baseline (T0), which will be when the parents give their consent and within the 8 months of life of the child, after 6 months from the start of the intervention (T1) and after 12 months from the start of the intervention (T2).
Technological assessment of social behaviour and joint attention:
- video recording of ESCP through Kinect Azure camera to collect and analyse quantitative data related to joint attention.
The administration of the ECSP-I will be video-recorded through an Azure Kinect camera to extract automatically gaze orientation and quantitatively assess Joint Attention.
- Eye-tracker acquisitions An experimental Eye-Tracker Screening (ETS) protocol for children will also be developed. Specifically, short videos will be used to measure the children's ability to process familiar/unfamiliar faces and to respond to social stimuli, particularly referential gaze. The children's eye movements will be analysed using the eye-tracker (Tobii Pro Fusion) and extracted using the appropriate software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age at recruitment less than or equal to 8 months.
- •Sibling diagnosed with autism spectrum disorder
- •Normal neurological examination
排除标准
- •Focal neurological signs/symptoms or suspicion of genetic-metabolic disorders
- •Genetically determined suspected or known conditions in brother/sister
- •Significant familial language barrier
结局指标
主要结局
Communication and Symbolic Behaviour Scales - Infant-Toddler Checklist (CSBS-IT-C)
时间窗: T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months)
is a tool for developmental screening, designed to measure 7 language predictors in children 6 to 24 months of age. The questions of the checklist may be presented in an interview format with adequate explanations to clarify what is being asked. It takes about 5 to 10 minutes to complete and permits the detection of signs of concern for ASD in infants and toddlers UNIT OF MEASURE: weighted score, number: range 3-17; no concern \> 7
Early Social Communication Scale (Échelle de la Communication Sociale Précoce, Italian adaptation, ECSP-I)
时间窗: T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months)
the ECSP-I is a structured assessment designed to provide measures of individual differences in nonverbal communication skills in children from 3 to 30 months of age. The administration requires 15-20 min involving the presentation of approximately 23 standardised situations which provide opportunities for social communication. The ECSP-I demonstrates strong reliability and both construct and discriminant validity Unit of measure: number. Optimal and average level (mean, range 1-4).
Satisfaction Survey
时间窗: T1 (T0 + 6 months)
Parents of children in Groups 2 and 3 will also be asked to anonymously complete a satisfaction survey (created ad hoc for this project) immediately after the intervention to assess their satisfaction with the services provided. The questionnaire takes 5 minutes to complete. unit of measure: likert scale, range 0-5
Griffiths Scales of Child Development, 3rd Edition (Griffiths-3)
时间窗: T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months)
Griffiths-3 is the gold standard to provide an overall measure of a child's development (0-6 years); it permits the definition of an individual profile of strengths and needs of the child across five areas: foundations of learning, language and communication, eye and hand coordination, personal-social-emotional, gross motor UNIT OF MEASURE: Developmental quotients (range 20-150, normality 85-115)
次要结局
- Laboratory- epigenetic analysis(T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months))
- Vineland Adaptive Behaviour Scales-II - Second Edition (Vineland-II)(T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months))
- McArthur-Bates questionnaire, child's first vocabulary (PVB) - gestures and words(T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months))
- Questionnaire Parent Stress Index - Short Form (PSI-SF)(T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months))
- Questionnaire Sensory Profile - Second Edition (SP-2)(T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months))
- Infant Behavior Questionnaire-Revised (IBQ-R) and Early Childhood Behavior Questionnaire (ECBQ)(T0 (recruitment); T2 (T0 + 12 months))
- Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)(T2 (T0 + 12 months))
- Autism Diagnostic Interview-Revised (ADI-R)(T2 (T0 + 12 months))
- Eye-tracker(T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months))
- Laboratory- genetic analysis(T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months))
- Parent interactions with children: Checklist of Observations Linked to Outcomes (PICCOLO)(T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months))
- Kinect(T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months))
- Laboratory- inflammatory cytokines and neurotrophic factors(T0 (recruitment), T1 (T0 + 6 months); T2 (T0 + 12 months))