The Food Allergy Superheroes Training (FAST) Program: Increasing Adherence to Food Allergy Safety Guidelines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Change in in situ food assessment score
研究概览
简要总结
Among children with a food allergy, strict avoidance (e.g., elimination of allergenic foods from one's diet) is the only intervention capable of preventing potentially devastating health-related sequelae including anaphylaxis and death. Youths from low-income backgrounds are particularly impacted by food allergies and may be the population most apt to benefit from a brief, portable, and engaging skills-based intervention designed to teach young children the skills needed to remain adherent to food allergy safety guidelines. Data collected as part of the proposed project will lay the groundwork for a line of federally-funded intervention research broadly examining how to promote adherence to food allergy safety guidelines among young children from low-income backgrounds through implementation of a robust, efficient, and portable intervention.
详细描述
The primary aim of this R21 proposal is to test the efficacy of a 5-session intervention designed to increase adherence to FA safety guidelines among low-income, young children (6-8 years of age) with FAs. This intervention, the Food Allergy Superheroes Training (FAST) Program, will be developed and refined across Phases 1a and 1b to target skills beneficial to promote adherence to FA guidelines (i.e., food avoidance). During Phase 1a, we will recruit a parent-child advisory board to aide in integrating principles of behavioral skills training within the FAST Program manual. We will then examine the initial acceptability and feasibility of the FAST Program in an open trial with 10 low-income, young children with FAs to further refine the intervention's content. During Phase 1b, we will randomize 50 young children with a FA who are from a low-income background to receive either the FAST Program or FA knowledge. We will employ developmentally relevant FA assessments (i.e., child-report, role-play, in situ) before, after, and one-month post-intervention as our primary outcomes. Aim 1: Determine feasibility and acceptability of the FAST intervention. We will evaluate the feasibility and acceptability of this intervention with 60 participants (n=10 in pilot trial [Phase 1a] and n=50 in a preliminary randomized trial [Phase 1b]). Aim 2: Estimate the effect size of the FAST intervention relative to FA knowledge alone. Adherence will be measured via a multi-modal, FA assessment including child-report, role-play, and in situ assessment. This form of naturalistic, FA assessment will be designed to measure the child's behavior (i.e., ingest food, touch or play with food, etc.) in a safe yet realistic manner. This study will contribute to the field's knowledge of efficacious interventions for promoting adherence among young children with FAs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Independent evaluators will assess pre-, post-, and follow-up naturalistic, food allergy assessment outcomes. These evaluators will have no knowledge as to the intervention participants received via their participation in this study.
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6-8 years of age.
- •Demonstrates a food allergy, based upon parent-report and confirmed diagnosis.
- •Family considered low-income (income-to-needs ratio <200% of Department of Health and Human Services Federal Poverty Threshold)
- •English as child's primary language
- •One English-speaking parent/guardian
排除标准
- •Neurodevelopmental disorder (i.e., autism spectrum disorder), cognitive delays, or psychiatric disorder, based upon parent-report.
结局指标
主要结局
Change in in situ food assessment score
时间窗: pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks)
Designed to provide an objective measure of a child's behavior to an unknown food-item in the real world. Modeled after similar methodology employed in prior skills training research. Study Independent Evaluation (IE) will introduce themselves as a visitor seeking to learn more about working with kids. IE will ask the parent for an empty room to setup their materials. After setup, the child will be asked to complete a simple task (e.g., choose a game or toy to play) whereby the child will come into contact with an unknown food-item (e.g., cookie laying on top of a coloring book). IE will provide minimal response to the child's behavior (e.g., eating food). Child?s response will be coded (see Research Strategy), based upon videotaped assessment made possible via a camera placed in the room. Higher scores (ranging from 0 to 3) indicate greater adherence. Inter-rater reliability will be obtained on 30% of in situ food assessments.
Change in child-report food assessment
时间窗: pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks)
The child-report food assessment will occur immediately following the role-play assessment. The study IE presents a scenario in which a child finds a food-item (e.g., playing at a friend's home). The IE will ask the child to state what he/she would do, if that situation happened to them. The child's response will be coded (see Research Strategy), based upon videotaped assessment made possible via a camera placed in the room. Higher scores (ranging from 0 to 3) indicate greater adherence. Inter-rater reliability will be obtained on 30% of child-report food assessments.
Change in role-play food assessment
时间窗: pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks)
The role-play assessment will occur immediately following the in situ assessment and is modeled upon similar methodology employed in prior skills training research. The study IE verbally presents the young child with a hypothetical scenario. For example, "Let's pretend that you are in your living room and your mom asks you to pick up your toys. While you are picking up your toys, you find candy. What would you do?" The IE will design each scenario so that the physical layout of the room permits the child to exhibit behavior congruent with the described situation. The child?s response will be coded (see Research Strategy), based upon videotaped assessment made possible via a camera placed in the room. Higher scores (ranging from 0 to 3) indicate greater adherence. Inter-rater reliability will be obtained on 30% of role-play food assessments.
次要结局
- Food Allergy Knowledge Test (FAKT)(pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks))
- Food Allergy Quality of Life - Parent Burden (FAQL-PB)(pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks))
- Food Allergy Management and Adaptation Scale (FAMAS)(pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks))
- Food Allergy Impact Scale (FAIS)(pre-intervention to post-intervention (approximately 2 weeks), pre-intervention to one-month follow-up (approximately 6 weeks), post-intervention to one-month follow-up (approximately 4 weeks))
研究者
Christopher Flessner
Associate Professor, Department of Psychological Sciences
Kent State University