Evaluation of the Effectiveness of a Mixed (Multifamily Group) Psychological Intervention Program for Children With Autism Spectrum Disorder and Feeding Difficulties (ASD+FD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Brief Assessment of Mealtime Behavior In Children (BAMBIC; Hendy et al. 2013).
研究概览
简要总结
Feeding difficulties are frequent in children with Autism Spectrum Disorder (ASD). The main goal of this project was to develop TEAlimento, a behavioral program for children ages 3-8 with ASD and feeding difficulties. The intervention combines parent training in group and individual sessions, as well as group sessions with children. The second goal was to conduct a pilot study to evaluate the effect of the program.
It was hypothesized that the intervention would decrease food rejection and disruptive behavior during meals, as well as increase the number of foods tried. A decrease in parent stress was also expected.
详细描述
Feeding difficulties are frequent in children with Autism Spectrum Disorder (ASD). The first goal was to develop TEAlimento, a behavioral program for children ages 3-8 with ASD and feeding difficulties. The second goal was to conduct a pilot study to evaluate the effect of the program.
Design A randomized waitlist -controlled clinical trial was designed to evaluate the effect of the program. The study ompared the intervention condition at two time points: baseline and 3 months later (our intervention program consisted of 12 sessions with a frequency of one session per week).
Initial effectivity data will be evaluated through the following specific indicators: limited variety of food, food rejection, disturbing behavior during meals and parent stress. Questionnaires to assess eating behaviors and parent stress will be administered before and after the intervention. Additionally, the number of new foods and food categories accepted after the intervention will be quantified. It was hypothesized that the intervention would decrease food rejection and disruptive behavior during meals, as well as increase the number of foods tried. A decrease in parent stress was also expected.
After approval by the review board of the Research and Ethics Committee of the Hospital, participants were recruited by psychologists and psychiatrists from a Multidisciplinary Unit for Autism Spectrum Disorder of a Child and Adolescent Mental Health Service, in accordance with the 2000 Helsinki Declaration.
Instruments
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
- None
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age range between 3 and 8 years old
- •confirmed diagnosis of cut-off at the Autism Diagnostic Observation Schedule-2 (ADOS-2, Lord et al., 2000)
- •presence of significant feeding difficulties, defined as one or more of the following issues: significant food rejection, significant disruptive behavior at meals, significant selectivity based on type, texture, and presentation, and significant stress to family caused by these feeding difficulties.
- •acquired oral-motor abilities to chew food
- •accepts eating at least three foods (and a maximum of 20).
排除标准
- •severe intellectual disability (intellectual or adaptive functioning below 35)
- •severe behavioral problems
- •medical risk situation that required more intensive intervention.
结局指标
主要结局
Change in Brief Assessment of Mealtime Behavior In Children (BAMBIC; Hendy et al. 2013).
时间窗: Before and after intervention (12 weeks later)
This questionnaire consists of 11 items that evaluate, on a 5-point Likert scale, three areas: limited variety, food refusal and disturbing behavior, in the last 6 months. Higher scores reflect more difficulties. The limited variety subscale assesses the child's willingness to try new foods or new types of preparation or textures. The food refusal subscale evaluates problem behaviors during meals, such as crying or closing his/her mouth tightly when food is presented. The disruptive behavior subscale includes items that assess aggressive behavior, self-injurious behaviors or disruptive conducts during meals, such as pushing or throwing utensils or food.
次要结局
- Change in Parenting Stress Index, short version (PSI-SF; Abidin 1995).(Before and after intervention (12 weeks later))
- Change in Qualitative questionnaire (ad hoc)(Before and after intervention (12 weeks later))