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

确认家庭治疗对低体重回避/限制性食物摄入障碍（ARFID）儿童的功效/机制

• 批准号: 10212222
• 负责人: JAMES D LOCK
• 金额: $ 69.59万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-07 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10212222
• 关键词: 12 year old; Academy; Address; Adolescent; Affect; Aftercare; Age; Ambulatory Care; American; Anorexia Nervosa; Attention; Blinded; Body Image; Body Weight; Bulimia; Caring; Child; Child Abuse; Child Care; Child Rearing; Choking; Cognition; Color; Conflict (Psychology); DSM-V; Data; Developmental Delay Disorders; Diagnosis; Diagnostic and Statistical Manual of Mental Disorders; Eating; Eating Behavior; Eating Disorders; Evidence based treatment; Exclusion; Family; Family Study; Family psychotherapy; Feasibility Studies; Feeding behaviors; Fright; Growth; Intelligence; Intervention; Intervention Studies; Interview; Lead; Maintenance; Malnutrition; Mediator of activation protein; Medical; Mental Health; Mental disorders; Monitor; Outcome; Parents; Participant; Patients; Pica Disease; Prevalence; Psychotic Disorders; Questionnaires; Randomized; Recording of previous events; Rumination Disorders; Self Efficacy; Sensory; Severities; Signal Transduction; Tail; Taste Perception; Texture; Time; Treatment outcome; Validation; Vomiting; Weight; Weight Gain; Youth; adverse outcome; avoidant restrictive food intake disorder; base; child neglect; comorbidity; effective therapy; efficacy evaluation; family structure; feeding; follow-up; interest; primary outcome; psychosocial; recruit; response; rho; secondary outcome; severe mental illness; social; treatment as usual; treatment duration; treatment effect

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).

回避性限制性食物摄入障碍(ARFID)是一种新的精神障碍的诊断和治疗 统计手册5(DSM-5)。ARFID的患病率估计为7.2%至17.4%，因此使其成为 严重的心理健康问题。ARFID的特征是一系列功能失调的饮食行为，包括 对进食缺乏兴趣，与进食有关的感官问题(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)。目前还没有针对ARFID的循证治疗。 比较FBT-ARFID和常规护理(UC)的可行性研究的初步数据提供了证据 手工化FBT适用于ARFID患者是可行和有效的。招募和随机化 在15个月的时间里，平均每月有1.87名参与者，总体流失率为21%，可比 到FBT-AN的全功率研究中的比率。可行性研究还确定了一种有效信号 两组之间的主要结果(百分比估计体重的变化(%EBW))的差异 倾向于FBT-ARFID的大效应研究表明，父母自我效能感的提高与 在治疗早期改变进食和饮食行为是FBT治疗其他进食障碍的一个可能机制 在年轻的时候。我们的可行性研究表明，父母的自我效能感在不同的条件下存在显著差异 FBT-ARFID与UC的比较。除了这一令人振奋的目标交战证据外，目标 父母自我效能感的变化与父母自我效能感显著相关 EBW百分比的改进。目标1：对6岁以下的儿童和青少年进行随机对照试验 DSM 5 ARFID和体重低于EBW 88%的12岁儿童与内科医生比较 管理到手工化非特效治疗UC，配合医疗管理。治疗将是匹配的 争取时间和心理医生的关注。我们假设随机参加FBT-ARFID的参与者将有 EOT时EBW百分比的变化明显更大。目的2：考察父母自我效能感的早期变化。 治疗效果的中介物(FBT-ARFID与UC在结果上的比较)。我们假设积极的变化是由于 FBT-ARFID在父母VS ARFID量表(PvsARFID)中与喂养行为相关的父母自我效能感 将与EOT的EBW百分比的积极变化相关。其次，我们将探索客观的 通过中介分析发现，FBT-ARFID的一个可能机制是亲代再摄食行为的改变。目标 3：探讨影响治疗结果的调节因素。为了进行一项有足够动力的研究，100名儿童(年龄 6-12岁)将随机分为手工化FBT-ARFID加医疗管理(n=50)或手工化非 对症治疗加内科管理(n=50)。评估(对治疗情况视而不见) 次要结果将在基线、1个月、2个月和4个月(EOT)进行。