Chompions! A Treatment Study for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Change in the number of clinically severe symptoms of Avoidant Restrictive Food Intake Disorder (ARFID) as measured by the PARDI (Pica, ARFID, and Rumination Diagnostic Interview)
研究概览
简要总结
Avoidant Restrictive Food Intake Disorder (ARFID) is a disorder that affects toddlers, children, adolescents, and adults. Individuals with ARFID are not able to consume an adequate amount or variety of food to a degree that it affects their mental and/or physical health. ARFID often begins in early childhood so it is important to treat children in early in life as possible to prevent any negative consequences of poor nutrition. There are currently no treatments for young children with ARFID. The investigators have developed two different study programs and the purpose of this study is to test them out and see if they help children with ARFID and to learn more about how these study programs work.
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)
盲法说明
Individuals who conduct the diagnostic interview will not be informed of the intervention arm to which a child is randomized.
入排标准
- 年龄范围
- 60 Months 至 119 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child is between 60 and 119 months (5 years and up to 9 years, 11 months)
- •English Speaking
- •Consent given by parent and assent by child
- •And any one or more of the following:
- •Score of 29 or above on the Child Food Neophobia Scale
- •Underweight
- •Current diagnosis of ARFID
- •Dependent on nutritional supplements to achieve sufficient calories for optimal growth
- •Avoiding activities due to eating rated at least almost always
排除标准
- •Child is known to have a severe intellectual disability based on medical chart review
- •Meets diagnostic criteria for anorexia nervosa or bulimia nervosa
- •Is currently enrolled in a treatment study or receiving active treatment for ARFID
- •Taking medications known to affect appetite
研究组 & 干预措施
Family Assisted Diet (FAD)
This is a 20-session intervention with a child and the child's parents that consists of helping parents set goals around their child's renourishment; consider barriers to implementing proposed plans; thinking through strategies to avoid barriers; and providing ongoing support for plan implementation.
干预措施: Family Assisted Diet (FAD) (Behavioral)
Feeling and Body Investigator_ARFID Division (FBI-ARFID)
This is a 20-session intervention with a child and the child's parents that consists of 4 components: 1) psychoeducation of somatic body sensations and sensory features of foods using playful characters (e.g., Aftertaste Anthony); 2) in-session exercises that expose family members to different body and food sensations so they can learn something new about their body and food; 3) body brainstorm worksheets that help them generalize what they learn in session to outside of treatment; and 4) Decision-tree practice worksheets that help them map body sensations to meanings and actions and to track explorations with food.
干预措施: Feeling and Body Investigator_ARFID Division (FBI-ARFID) (Behavioral)
结局指标
主要结局
Change in the number of clinically severe symptoms of Avoidant Restrictive Food Intake Disorder (ARFID) as measured by the PARDI (Pica, ARFID, and Rumination Diagnostic Interview)
时间窗: Baseline, Post-Treatment (up to 30 weeks), 3-Months Post-Treatment
The 17-item PARDI measures symptoms including body mass index, diet quality, dependence on supplement use for sufficient calories, and psychosocial impairment. Each item assesses a symptom on a 0 - 6 scale, with scores above 4 indicating that it is a clinically severe symptom.
次要结局
- Nutrition Quality as measured by 3-day 24-hour dietary recalls(Post-Treatment (up to 30 weeks))
- Nutrition Quantity as measured by 3-day 24-hour dietary recalls(Post-Treatment (up to 30 weeks))
- Psychosocial Functioning as measured by items on the PARDI(3-Months Post-Treatment)
- Body Mass Index (BMI) as measured by height and weight(3-Months Post-Treatment)
- Nutrition Quantity as measured by 3-day 24-hour dietary recalls(Baseline)
- Psychosocial Functioning as measured by items on the PARDI(Baseline)
- Psychosocial Functioning as measured by items on the PARDI(Post-Treatment (up to 30 weeks))
- Nutrition Quality as measured by 3-day 24-hour dietary recalls(Baseline)
- Body Mass Index (BMI) as measured by height and weight(Baseline)
- Body Mass Index (BMI) as measured by height and weight(Weekly (up to 30 weeks))
- Body Mass Index (BMI) as measured by height and weight(Post-Treatment (up to 30 weeks))