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临床试验/NCT03138551
NCT03138551已完成不适用

Examining Relationships Between Family Mealtime Routines and Feeding Outcomes in Young Children With Sensory Food Aversions

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年10月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Food Acceptance

研究概览

简要总结

This study will examine the feasibility and preliminary effects of the Mealtime PREP (Promoting Routines of Exploration and Play) intervention package for young children with Sensory Food Aversions and their parents.

详细描述

This pilot study will collect rich data from twenty participants on the feasibility and effects of a novel intervention, the Mealtime PREP, which has a dyadic focus on both the young child and the parent participants. The investigators will collect video recorded child meals in the home during a baseline period (under normal circumstances), during parent-training (while parents are practicing skills learned), and following parent training (when therapist support is withdrawn). This in depth examination of child meals will provide valuable information to guide the optimization of this intervention approach for future trials.

研究设计

研究类型
Interventional
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Months 至 60 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Child must meet all criteria of the diagnosis of Sensory Food Aversions
  • The child consistently refuses to eat specific foods with specific tastes/textures and/or smells.
  • Onset of food refusal occurs during the introduction of a novel type of food (e.g., the child may drink one type of milk but refuse another, may eat carrots but refuse green beans, may drink milk but refuse baby food).
  • The child eats without difficulty when offered preferred foods.
  • The food refusal causes specific nutritional deficiencies or delay of oral motor development.
  • Parent is able to read, write, speak and understand English.

排除标准

  • 未提供

研究组 & 干预措施

Mealtime PREP

Experimental

Every participant enrolled in this single-case experimental design trial with multiple replications progressed through three phases.

A: Baseline - typical mealtimes in the home.

B: Parent-Training - parents trained in Mealtime PREP (Promoting Routines of Exploration and Play) intervention.

B-prime: Family Autonomy - parents continue to deliver treatment strategies. Therapist support withdrawn.

干预措施: Mealtime PREP (Promoting Routines of Exploration and Play) (Behavioral)

结局指标

主要结局

Food Acceptance

时间窗: 30 meals video recorded throughout study participation (10 per phase, 1 month)

Significant change in percentage of targeted food accepted between phases.

次要结局

  • Behavioral Pediatric Feeding Assessment (BPFAS)(Baseline through Study Completion (1 month))
  • 3-Day Food Diary(Baseline through Study Completion (1 month))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Angela Caldwell

Assistant Professor

University of Pittsburgh

研究点 (1)

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