Autism MEAL Plan: Parent Training to Manage Eating Aversions & Limited Variety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in Clinical Global Impression - Improvement scale (CGI-I) score
研究概览
简要总结
The Autism Managing Eating Aversions and Limited variety (MEAL) Plan is a group-based parent training intervention designed to assist parents in increasing the variety of foods eaten in children with Autism Spectrum Disorder (ASD). The goal of the Autism MEAL Plan is to include specific techniques to manage mealtime behavioral challenges and introduce new foods.
详细描述
The Autism Managing Eating Aversions and Limited variety (MEAL) Plan is a structured parent-mediated, group-based intervention to reduce mealtime disruptive behavior, expand dietary diversity and reduce parental stress associated with moderate food selectivity in young children with Autism Spectrum Disorder (ASD).
Children ages 3-8 with a diagnosis of ASD who present with moderate food selectivity and associated problem behavior will be screened for inclusion in the study. Following consent and screening procedures, parents of eligible children will be assigned to a group-based parent training (Autism MEAL plan) or group-based parent education. Each parent will receive 1.5 hours of intervention per week for 10 weeks by a masters or doctoral level clinician.
Data will be collected on parental compliance with the Autism MEAL plan and the food acceptance of the child as well as nutritional intake, and refusal behaviors. Child participants will also be included in parent-child dyad in-vivo feedback sessions. Parents assigned to parent education will be able to cross-over to receive the Autism MEAL Plan following completion of post-study measures.
The first aim of the study is to finalize the Autism MEAL Plan materials (e.g., role-play activities, activity sheets and video examples). This includes standardizing therapist scripts in line with the revised curriculum and creating new video examples that coincide with practice worksheets. Home recording (e.g., personal camera phone) to document and present home meal data will also be added to the curriculum.
The second aim is to evaluate the feasibility of the Autism MEAL Plan versus parent education in 40 children (20 per treatment assignment) with ASD and moderate feeding problems.
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 (Outcomes Assessor)
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
- •(for children):
- •A diagnosis of autism spectrum disorder (ASD), supported by the Autism Diagnostic Observation Schedule (ADOS) and the Social Communication Questionnaire (SCQ)-Lifetime
- •Presents with a history of moderate food selectivity (a diet involving at least 6 food items)
- •Accepting at least one fruit or vegetable
- •Fewer than two food items in one or more food categories (i.e., fruit, vegetable, protein, starch) as measured by the Food Preference Inventory
- •Exhibits disruptive refusal behaviors when presented with non-preferred foods (e.g., crying, active verbal protest, tantrums) often or during every meal as indicated by item 7 on the Brief Autism Mealtime Behavior Inventory (BAMBI)
- •Inclusion Criteria (for parents or primary caregivers):
- •Parent, or primary caregiver, endorses a feeding concern as one of the top two problems on the Parent Target Problem
- •Parent, or primary caregiver, agrees to participate and is deemed able to attend group sessions
- •Parent, or primary caregiver, is able to speak, understand, read and write in English
排除标准
- •(for children):
- •Severe feeding problems (e.g., < 5 preferred foods as measure by the Food Preference Inventory)
- •Complex medical issues (e.g., gastrostomy tube or formula dependent) requiring intensive treatment such as day treatment or hospital-based treatment
研究组 & 干预措施
Autism MEAL Plan
Parents of eligible children who are randomized to the Autism Managing Eating Aversions and Limited variety (MEAL) Plan will participate in group-based parent training sessions (4 parents per group).
干预措施: Autism MEAL Plan (Behavioral)
Parent Education
Parents of eligible children who are randomized to the Parent Education Arm will receive group-based parent education (PE). Each group includes 4 parents.
干预措施: Parent Education (Behavioral)
结局指标
主要结局
Change in Clinical Global Impression - Improvement scale (CGI-I) score
时间窗: Baseline, end of follow-up (up to 18 weeks)
The Clinical Global Impression - Improvement scale (CGI-I) is a 7-point scale measure of overall change of Parent Target Problems (the child's two most pressing problems at screening, as reported by parents), using scores from the Clinical Global Impressions - Severity scale (CGI-S). Scores range from 1 (Very Much Improved) through 4 (Unchanged) to 7 (Very Much Worse).
次要结局
- Change in Parenting Stress Index- Short Form (PSI) score(Baseline, end of follow-up (up to 18 weeks))
- Parent Satisfaction Rating(Week 14)
- Change in rapid swallowing during 10-minute meal observation(Baseline, end of follow-up (up to 18 weeks))
- Change in crying during 10-minute meal observation(Baseline, end of follow-up (up to 18 weeks))
- Body Mass Index(Baseline, end of follow-up (up to 18 weeks))
- Change in Brief Autism Mealtime Behavior Inventory (BAMBI) scores(Baseline, end of follow-up (up to 18 weeks))
- Change in Food Preference Inventory (FPI) scores(Baseline, end of follow-up (up to 18 weeks))
- Change in nutritional intake(Baseline, end of follow-up (up to 18 weeks))
- Change in Aberrant Behavior Checklist (ABC) scores(Baseline, end of follow-up (up to 18 weeks))
- Change in rapid acceptance during 10 minute meal observation(Baseline, end of follow-up (up to 18 weeks))
- Change in disruptions during 10-minute meal observation(Baseline, end of follow-up (up to 18 weeks))
- Height(Baseline, end of follow-up (up to 18 weeks))
- Change in volume of food consumed during 10-minute meal observation(Baseline, end of follow-up (up to 18 weeks))
- Weight(Baseline, end of follow-up (up to 18 weeks))
研究者
William Sharp, PhD
Assistant Professor
Emory University