Relationship Between Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism Spectrum Disorder and Parental Stress Perceived
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Gastrointestinal severity symptom index (GSSI)
研究概览
简要总结
Brief Summary: Eating problems and in particular food selectivity is a condition that worsens a long-life disorder such as Autism Spectrum Disorder (ASD) , both on an individual level, both on family and social ones .
Children (2-6 years) diagnosed with ASD according to Diagnostic and Statistical Manual of Mental Disorders 5 Edition (DSM5) criteria were enrolled in an observational, cross-sectional and multicentric study conducted by three different Italian clinical centers. Regarding this sample, principal aims of the study are to describe characteristics of food selectivity, to evaluate its correlation with ASD symptoms, with cognitive and adaptive functioning of ASD preschoolers, to describe its impact on parental stress.
详细描述
Background: Eating problems and in particular food selectivity is a condition that worsens a long-life disorder such as ASD, both on an individual level , both on family and social ones . Regarding factors that contribute to this eating behavior have been identified sensory atypia , rigid behaviors and behavioral problems , however the problem has not yet been fully clarified.
Objective: The study aims to:
a) evaluate the presence and characteristics of food selectivity, in a sample of preschool children with ASD, the impact of this on the child's height and weight growth, the possible correlation with gastrointestinal symptoms and with oro-motor skills; b) assess the correlation between food selectivity and the characteristics of ASD (sensory atypia, repetitive behaviors, level of severity of symptoms), the cognitive development/ability quotient, adaptive functioning and the presence of behavioral disorders; c) highlight the impact of food selectivity of ASD children on parental stress.These aims are relevant in order to identify possible future therapeutic interventions that rate both the child's needs and parents involvement.
Methods: children (2-6 years) diagnosed with ASD according to DSM-5 criteria at the IRCCS Stella Maris institute (Clinical Unit ASD Department), were enrolled in an observational, cross-sectional and multicentric study conducted by three different Italian clinical centers (IRCCS Stella Maris Foundation Pisa, Regional Center for Autism Spectrum Disorders - Verona, Observation Diagnostic Training Lab - Trento). This study received the approval of the Tuscany Regional Ethics Committee for the pediatric age (Meyer).
In detail, the study involves parents by administering an anamnestic interview regarding the medical history and development of the child, the rehabilitation and pharmacological intervention in progress; the collection of a video recording of two meals in a family context. Parents complete a series of questionnaires including Child Oral and Motor Proficiency Scale( ChOMPS ), Brief Autism Mealtime Behavior Inventory, (BAMBI) ; Sensory Profile 2( SP2); Child Behavior Checklist (CBCL) 1.5-5 or 6-18 ; Parenting Stress Index, (PSI); Food diary ; Autism-Spectrum Quotient Test (AQ) ); Gastrointestinal Symptom Severity Index (GISSI); Mac Arthur questionnaire . The study includes the evaluation of children' cognitive functioning through the administration of a psychometric/developmental test, the administration of a standardized test for the evaluation of socio-communicative skills (Autism Diagnostic Observation Schedule 2 Edition ) and the observation of a meal of the child at the institute. The study provides a database dedicated to the collection data obtained.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Brain Malformation
- •Genetic syndromes
- •specifical neurological signs
- •prematurity
- •non free diet.
结局指标
主要结局
Gastrointestinal severity symptom index (GSSI)
时间窗: baseline
It is a questionnaire to evaluate presence of gastrointestinal symptoms. It takes 5-10 minutes to compile. A score of 4 or higher (with at least 3 points deriving from the first 6 items which specifically investigate the most common symptoms gastrointestinal) is considered clinically significant to identify relevant gastrointestinal symptoms. There is also an additional section on behaviors associated (verbal and motor) which have been linked to the presence of gastrointestinal symptoms in subjects with ASD.
Brief Autism Mealtime Behavior Inventory (BAMBI)
时间窗: baseline
It is a questionnaire consisting of 15 items for the evaluation of food problems referable to a food selectivity framework (total score greater than or equal to 34). It includes four different domains "food selectivity", "destructive behaviors during meals", "food refusal","rigidity during meals" and a total score.
Parenting Stress Index (PSI)
时间窗: baseline
It is a questionnaire that measures parental stress level in the parent-child system. It is made up of two domains, Child Domain and Parent Domain composed by 4 sub-scales, which together form the Total Stress scale.The Short Form of PSI-4 (PSI-4-SF) is organized into three sub-scales, Parental Distress, Parent-Child Interaction dysfunctional and Difficult Child. There is also the Defensive Response, which allows you to have information on the respondent's defensive attitude.
Observation of child meal-time
时间窗: baseline
On-line observation of child habits during meal-time
Child Oral and Motor Proficiency Scale (ChOMPS)
时间窗: baseline
It is a questionnaire that evaluates the motor and oral-motor skills that underlie the eating and drinking ability for children aged six months to seven years. It consists of a score total divided into four different subscales: "basic movement patterns", "oral-motor skills fundamentals", "oral-motor coordination" and "complex movement patterns".
Child Behavior Checklist (CBCL)
时间窗: baseline
It is used to evaluate developmental psychopathology through scales that assess specific dimensions (Anxiety/Depression; Withdrawal/Depression; Somatic Complaints; Social Problems; Thinking Problems; Attention Problems; Rule-Breaking Behaviors; Aggressive Behaviors), general (Internalizing, Externalizing, and Total Problems), emotional-behavioral problems according to some of the DSM diagnostic categories (Affective Problems; Anxiety Problems; Somatic Problems; Attention-Deficit/Hyperactivity Problems; Oppositional-Provocative Problems; Conduct Problems). In the present study parent form is used.
Sensory Profile 2 (SP2)
时间窗: baseline
This questionnaire administered to parents, has the purpose of identifying atypical sensory processing and in particular impairments referable to sensory processing that could be related to food selectivity (normal profile,moderately atypical or clearly atypical for age in the processing of individuals sensory channels, in modulation, in behavior and emotional responses).
Food Diary
时间窗: baseline
It was adapted from the original one of the "Zoom8"survey financed by the Istituto Superiore di Sanità, which studies adherence to the Mediterranean diet in school-age children in Italy. The parents of each child included in the study will record the usual eating habits of his/her child refer to the last year. Its administration has the aim of analyzing the types of foods taken by children with ASD with or without food selectivity
Mac Arthur
时间窗: baseline
It is a questionnaire to evaluate the linguistic level. It collects important information on the development of children's abilities in language, including receptive vocabulary, production, gestures repertoire and grammar.
次要结局
- Autism Quotient (AQ)(baseline)
- Vineland-II scales (VABS II)(baseline)
- Autism Diagnostic Observation Schedule-2 (ADOS-2)(baseline)
研究者
Raffaella Tancredi
MD Director Clinical Unit
IRCCS Fondazione Stella Maris