The Impact of Desensitization as a Modality to Reduce Oral Hypersensitivity and Improve Intake in Children With Pediatric Feeding Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change from baseline frequency of packs at 8 weeks,or when treatment goals are met
研究概览
简要总结
Many children with feeding disorders frequently gag, vomit, spit out their food, and/or hold food in their cheeks. These behaviors make it difficult for children to eat enough food to grow. The purpose of this study is to evaluate if a specific behavioral feeding intervention called desensitization is an effective intervention to improve oral intake in children with feeding disorders by decreasing gagging, vomiting, spitting, and holding food in the cheeks. The study will enroll eligible children (6) and their caretakers (6) in the study and they will receive behavioral feeding treatment. All treatment sessions will be videotaped and the study will last a maximum 8 weeks after the first treatment visit, or until treatment goals have been met.
详细描述
Children with complex medical histories may have limited, delayed, or no early oral feeding experiences, which decreases the likelihood of independently developing appropriate oral motor skills required for eating. Children who are introduced to solid foods after 6-7 months of age frequently gag, choke, or vomit due to inefficient oral-motor skills. In typically developing children, gagging weakens as a child learns to chew around 7-months of age. However, children with feeding disorders do not have the same opportunities to weaken the natural gag reflex due to limited experience with oral feedings. As a result, they often become hypersensitive to any tactile stimulation and averse to foods and utensils touching specific parts of the mouth. There is a gap in the behavioral feeding literature addressing oral hypersensitivity and behaviors that interfere with swallowing (i.e., packing, expelling, gagging, vomiting). Some work surrounding desensitization of the oral cavity has already been done within other disciplines (i.e., occupational therapists and speech and language pathologists); however, desensitization has not been well-defined, nor has it been empirically studied.
(1) Specific Aims: The proposed study is designed to assess the following aims:
- Define an oral-desensitization protocol to improve oral intake and decrease gags and emesis in children with feeding disorders.
- Evaluate the efficacy of the brief implementation of an oral-desensitization protocol alone and in combination with the antecedent-based procedure, flipped spoon.
- To explore the relationship between behavioral feeding intervention and child oral and motor proficiency.
- To explore the relationship between behavioral feeding intervention and parent and child outcomes including parenting stress, mealtime feeding behaviors, and general child behavioral functioning.
(2) Research Hypotheses: The proposed study is designed to test the following hypotheses:
- Effect of flipped spoon versus flipped spoon + desensitization. It is hypothesized that there will be a faster decrease in (1) gags, (2) latency to clean mouth, (3) packs, (4) emesis, and (5) CI's with those participants who receive oral desensitization prior to the flipped spoon intervention. It is also hypothesized that children who receive desensitization prior to flipped spoon will be able to transition back to an upright spoon more quickly when compared to children who did not receive desensitization.
- Effect of behavioral feeding intervention on child oral and motor proficiency. Exploratory analyses will be conducted to examine pre-test and post-test ratings of child oral and motor proficiency. It is anticipated that the oral-motor coordination of the participants will significantly improve.
- The relationship between behavioral feeding intervention and parent/child outcomes. Exploratory analyses will be conducted to examine pre-test and post-test ratings of parenting stress, mealtime feeding behaviors, and general child behavioral and emotional functioning. It is anticipated that parent-reported ratings in these areas will improve from pre-test to post-test.
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
- 10 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Behavior problems (i.e., spitting, crying, head turning, gagging, physical aggression) are interfering with feeding
- •Medical causes of feeding disorder have been treated or are well-controlled without resolution of the feeding problem
- •Normal feeding milestones have not been met or regression has occurred
- •Enteral feeding dependence as defined by the participant relying on Nasal Gastric or gastrostomy-tube feedings in order to receive appropriate nutrition and gain weight
- •Accepts a limited number of foods and limited volume of foods by mouth (i.e., not enough variety or volume to maintain growth and/or good nutritional status)
排除标准
- •Children who had anatomical/active medical problems that prohibit safe oral intake will be excluded
结局指标
主要结局
Change from baseline frequency of packs at 8 weeks,or when treatment goals are met
时间窗: Baseline, up to eight weeks after first treatment visit
Participants will be observed for number of packs to evaluate the effectiveness of Desensitization
Change from baseline frequency of gags at 8 weeks, or when treatment goals are met
时间窗: Baseline, up to eight weeks after first treatment visit
Participants will be observed for gags to evaluate the effectiveness of Desensitization
Change from baseline latency to clean mouth at 8 weeks, or when treatment goals are met
时间窗: Baseline, up to eight weeks after first treatment visit
Participants will be observed for latency to clean mouth to evaluate the effectiveness of Desensitization
Change from baseline frequency of emesis at 8 weeks, or when treatment goals are met
时间窗: Baseline, up to eight weeks after first treatment visit
Participants will be observed for emesis to evaluate the effectiveness of Desensitization
Change from baseline frequency of combined inappropriate behaviors (CI's) at 8 weeks, or when treatment goals are met
时间窗: Baseline, up to eight weeks after first treatment visit
Participants will be observed for CI's to evaluate the effectiveness of Desensitization
次要结局
- Pediatric Eating Assessment Tool (PediEAT)(Baseline (pre-treatment), up to eight weeks (post-treatment))
- Family Management Measure of Feeding Questionnaire (FaMM Feed)(Baseline (pre-treatment), up to eight weeks (post-treatment))
- Parenting Stress Index-Short Form, 4th Edition (PSI4-SF)(Baseline (pre-treatment), up to eight weeks (post-treatment))
- Child Oral and Motor Proficiency Scale (ChOMPS)(Baseline (pre-treatment), up to eight weeks (post-treatment))
- Child Behavior Checklist (CBCL) for ages 1 1/2 to 5 years old(Baseline (pre-treatment), up to eight weeks (post-treatment))
- Child Behavior Checklist (CBCL) for ages 6-10 years old(Baseline (pre-treatment), up to eight weeks (post-treatment))
- Change in Body Weight(Baseline (pre-treatment), up to eight weeks (post-treatment))
- Change in Height(Baseline (pre-treatment), up to eight weeks (post-treatment))
- Change in Mid-upper arm circumference(Baseline (pre-treatment), up to eight weeks (post-treatment))
- Change in Hand Grip Strength(Baseline (pre-treatment), up to eight weeks (post-treatment))
研究者
Natalie Morris
Principal Investigator
University of Michigan