Confirming the Efficacy/Mechanism of Family Therapy for Children with Low Weight Avoidant/Restrictive Food Intake Disorder (ARFID)

回避性限制性食物摄入障碍（ARFID）是一种新的精神疾病， 统计手册5（DSM-5）。ARFID的估计流行率为7.2%至17.4%，因此使其成为 严重心理健康问题。ARFID的特征是一系列功能失调的饮食行为，包括 对饮食缺乏兴趣，与感官相关的饮食问题（如味道，颜色或质地）以及对不良反应的恐惧 进食的后果（即，害怕窒息或呕吐）。ARFID没有循证治疗。 一项将FBT-ARFID与家庭护理（UC）进行比较的可行性研究的初步数据提供了证据， 适合ARFID患者的手动FBT是可行和有效的。招募和随机化 在15个月期间，平均每月1.87名参与者，总流失率为21%， FBT-AN的全功率研究中的比率。可行性研究还确定了关于 组间主要结局（估计体重百分比（%EBW）的变化）的差异 支持FBT-ARFID研究的大效应量（ES）表明，父母自我效能感的改善与以下因素有关： 在治疗早期改变喂养和进食行为可能是FBT治疗其他进食障碍的机制 在年轻的时候。我们的可行性研究表明，父母自我效能感的条件之间存在显着差异， FBT-ARFID与UC相比。除了这一有希望的目标参与证据之外， 父母自我效能感的变化与以下因素显著相关， 改善EBW %。目的1：开展一项涉及6岁以下儿童和青少年的RCT 和12岁，DSM 5 ARFID和体重低于EBW的88%，比较FBT-ARFID与医疗 管理到手动非特异性治疗UC与医疗管理。治疗将匹配 争取时间和治疗师的关注我们假设随机分配到FBT-ARFID的参与者将有 EOT时%EBW的变化显著更大。目的2：探讨父母自我效能感的早期变化， 治疗效果的中介因素（FBT-ARFID与UC的结局）。我们假设，积极的变化，由于 使用父母与ARFID量表（PvsARFID）评估FBT-ARFID与喂养行为相关的父母自我效能 将与EOT时%EBW的正变化相关。其次，我们将探讨是否客观 父母再喂养行为的变化是一个可能的机制FBT-ARFID使用中介分析。目的 3：探讨治疗结果的调节因素。为了进行充分的研究，100名儿童（年龄 6-12年）将随机分配至手动FBT-ARFID+医疗管理组（n=50）或手动非ARFID组（n = 50）。 特定治疗加药物管理（n=50）。主要受试者的评估（对治疗条件设盲） 次要结局将在基线、1个月、2个月和4个月（EOT）时进行。

Avoidant restrictive food intake disorder (ARFID) is a new psychiatric disorder in the Diagnostic and Statistical Manual 5 (DSM-5). ARFID has an estimated prevalence of 7.2 to 17.4 percent thus making it a significant mental health concern. ARFID is characterized by a range of dysfunctional eating behaviors including a lack of interest in eating, sensory related eating concerns (such as taste, color or texture) and a fear of adverse consequences of eating (i.e., fear of choking or vomiting). There is no evidence-based treatment for ARFID. Preliminary data from a feasibility study comparing FBT-ARFID to Usual Care (UC) provide evidence that manualized FBT adapted for patients with ARFID is feasible and effective. Recruitment and randomization averaged 1.87 participants per month over a 15 month period with an overall attrition rate of 21%, comparable to rates in fully powered studies of FBT-AN. The feasibility study also identified an efficacy signal on the difference between groups on the primary outcome (change in percent Estimated Body Weight (%EBW)) of a large effect size (ES) favoring FBT-ARFID Studies suggest that improvements in parental self-efficacy related to changing feeding and eating behaviors early in treatment is a likely mechanism of FBT for other eating disorders in youth. Our feasibility study showed a striking difference between conditions in parental self-efficacy favoring FBT-ARFID compared to UC. In addition to this promising evidence of target engagement In addition, target validation was demonstrated by the change in parental self-efficacy being significantly correlated with improvements in % EBW. Aim 1: To conduct an RCT involving children and adolescents between the ages of 6 and 12 years of age with DSM 5 ARFID and weight below 88% of EBW comparing FBT-ARFID with medical management to manualized Non-Specific Treatment UC with medical management. Treatments will be matched for time and therapist attention. We hypothesize that participants randomized to FBT-ARFID will have significantly greater change in %EBW at EOT. Aim 2: To examine early change in parental self-efficacy as a mediator of treatment effect (FBT-ARFID vs. UC on outcome). We hypothesize that positive changes due to FBT-ARFID in parental self-efficacy related to feeding behaviors using the Parents vs ARFID Scale (PvsARFID) will be associated with positive changes in %EBW at EOT. Secondarily, we will explore whether objective changes in parental re-feeding behavior is a possible mechanism of FBT-ARFID using a mediator analysis. Aim 3: To explore moderators of treatment outcome. To conduct an adequately powered study, 100 children (ages 6-12 years) will be randomized to manualized FBT-ARFID plus medical management (n=50) or manualized Non- Specific Treatment plus medical management (n=50). Assessments (blinded to treatment condition) of primary and secondary outcomes will be conducted at baseline, 1 month, 2 months, and 4 months (EOT).