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: 10427302
• 负责人: JAMES D LOCK
• 金额: $ 68.18万
• 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/10427302
• 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; effective therapy; efficacy evaluation; family structure; feeding; follow-up; interest; primary outcome; psychiatric comorbidity; 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).

回避限制性食物摄入障碍（ARFID）是诊断和 统计手册5（DSM-5）。 ARFID的估计患病率为7.2至17.4％，因此 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 缺乏对饮食的兴趣，与感官相关的饮食问题（例如味道，颜色或质地）以及对不利的恐惧 饮食的后果（即害怕窒息或呕吐）。没有基于证据的ARFID处理。 可行性研究的初步数据将FBT弧形与常规护理（UC）进行了比较（UC）提供了证据表明 适用于ARFID患者的手动化FBT是可行且有效的。招募和随机分组 在15个月内平均每月1.87名参与者，总体流失率为21％，可比 在FBT-AN的全力研究中率。可行性研究还确定了对 主要结果的组之间的差异（估计体重百分比（％EBW）的变化） 有利于FBT arfid研究的巨大影响大小（ES）表明，与父母自我效能相关的改善 治疗早期改变喂食和饮食行为是其他饮食失调的可能机制 在青年时期。我们的可行性研究表明，父母自我效能感的条件有偏好的差异 与UC相比，FBT arfiD。除了这一有希望的目标参与的证据外，目标 父母自我效能感的变化与与 ％EBW的改进。目标1：进行涉及6岁之间儿童和青少年的RCT 与DSM 5 Arfid和重量低于88％的EBW的12岁，将FBT arfid与医学进行比较的重量低于88％ 通过医疗管理的管理非特异性治疗UC的管理。治疗将匹配 时间和治疗师的关注。我们假设参与者随机将 EOT％EBW的变化明显更大。目标2：检查父母自我效能的早期变化 治疗效果的介体（FBT-ARFID与UC关于结果的UC）。我们假设由于 在父母的自我效能上，fbt arfiD与父母与arfid量表（PVSARFID）有关 EOT％EBW的积极变化将与EOT的积极变化有关。其次，我们将探讨是否目标 父母重新喂养行为的变化是使用介体分析的FBT屈曲的可能机制。目的 3：探索治疗结果的主持人。为了进行足够动力的研究，有100名儿童（年龄 6 - 12年）将被随机分配给手动fbt-arfid加拿大医疗管理（n = 50）或手动非 - 特定的治疗加医学管理（n = 50）。初级评估（对治疗状况蒙蔽） 次要结果将在基线，1个月，2个月和4个月（EOT）进行。