跳至主要内容
临床试验/NCT06179940
NCT06179940招募中不适用

Evaluation of the Effect of Food Selectivity Intervention in Children With Autism Spectrum Disorders.

Istituto per la Ricerca e l'Innovazione Biomedica2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
inventory of food preferences

研究概览

简要总结

Food selectivity is a common challenge among children with Autism Spectrum Disorder (ASD), with significant impacts on their nutrition and well-being. The main purpose of this study is to promote children's active participation in mealtime routines and encourage experimentation with new foods through an approach that emphasizes joy and serenity during mealtimes. The study will involve children with ASD between the ages of 4 and 10 years, of both sexes. Food selectivity will be assessed through interviews with parents and the use of specially created cards.

The protocol will include 45-minute sessions, twice a week, for a total of 48 sessions. During these sessions, two plates, a list of foods previously agreed upon with the parents, and the foods needed for each session will be used. The sessions will take place in an environment called "Home Lab"a specially set up as if it were a kitchen to reproduce a home atmosphere.

详细描述

Food selectivity training is divided into three steps. Step 1- Pairing in the kitchen. Propose highly enjoyed activities to the child in the kitchen. Criterion for moving to step 2: Child stays in the kitchen to play for 5 minutes for 3 consecutive sessions.

Indicate the minutes of playing in the kitchen.

Step 2 Food selectivity training is divided into three steps. Step 1- Pairing in the kitchen. Propose highly enjoyed activities to the child in the kitchen. Criterion for moving to step 2: Child stays in the kitchen to play for 5 minutes for 3 consecutive sessions.

Indicate the minutes of playing in the kitchen. Step 2 At the beginning of the session prepare two identical plates, in each plate there will be 6 foods, arranged in the same way. Place them on the table in the kitchen.

Training

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
Single (Participant)

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Food selectivity upon parental referral
  • diagnosis of autism

排除标准

  • presence of other medical disorders

结局指标

主要结局

inventory of food preferences

时间窗: The test need approximately 20 minutes

The food preference inventory includes a list of foods that is submitted to the parent. Asked how often the food is consumed by the child and family

Brief Autism Mealtime Behavior Inventory (BAMBI)

时间窗: The test need approximately 10 minutes

the Bambi measures food selectivity, disruptive behavior, food refusal and rigidity at mealtime The 18-item Brief Autism Mealtime Behavior Inventory (BAMBI) is a parent-report questionnaire that was created to identify mealtime habits unique to kids with ASD. The BAMBI is rated on a Likert scale of 1 to 5, where 1 represents "never" occurring behavior during mealtime and 5 represents "always" occurring behavior. For four of the items that rate constructive mealtime behaviors, reversed scoring is applied. The sum of the 18 elements is used to create the total frequency score, with higher scores indicating more issues with behavior during meals.

general assessment checklist

时间窗: The test need approximately 15 minutes

the general assessment includes a personal data sheet, the section relating to nutrition and therefore to the dietary regime, the type of selectivity and dysfunctional behaviours. Finally there is the adaptive functioning card relating to autonomy during meals.

次要结局

未报告次要终点

研究者

发起方
Istituto per la Ricerca e l'Innovazione Biomedica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Flavia Marino

Head of Unit

Istituto per la Ricerca e l'Innovazione Biomedica

研究点 (2)

Loading locations...

相似试验