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

基本信息

批准号：
10039552
负责人：
JAMES D LOCK
金额：
$ 70.96万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
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/10039552
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 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

项目摘要

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）是诊断和治疗领域的一种新的精神疾病。统计手册 5 (DSM-5)。 ARFID 的流行率估计为 7.2% 至 17.4%，因此使其成为重大的心理健康问题。 ARFID 的特点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（例如味道、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 的循证治疗方法。将 FBT-ARFID 与常规护理 (UC) 进行比较的可行性研究的初步数据提供了以下证据：适用于ARFID患者的手动FBT是可行且有效的。招募和随机化 15 个月内平均每月有 1.87 名参与者，总体流失率为 21%，可比 FBT-AN 的全动力研究中的比率。可行性研究还确定了一个功效信号组间主要结果的差异（估计体重百分比 (%EBW) 的变化）大效应量（ES）有利于 FBT-ARFID 研究表明，父母自我效能感的提高与在治疗早期改变喂养和饮食行为是 FBT 治疗其他饮食失调的一个可能机制在青春里。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 的比较。除了目标参与的这一有希望的证据之外，目标父母自我效能感的变化与 EBW 百分比的改进。目标 1：开展一项涉及 6 岁儿童和青少年的随机对照试验 12 岁，使用 DSM 5 ARFID，体重低于 EBW 88%（将 FBT-ARFID 与医疗设备进行比较）管理到手动非特异性治疗 UC 与医疗管理。治疗将进行匹配以获得时间和治疗师的关注。我们假设随机接受 FBT-ARFID 的参与者将有 EOT 时 %EBW 变化显着更大。目标 2：检查父母自我效能感的早期变化治疗效果的中介变量（FBT-ARFID 与 UC 对结果的影响）。我们假设积极的变化是由于使用父母与 ARFID 量表 (PvsARFID) 评估与喂养行为相关的父母自我效能感中的 FBT-ARFID 将与 EOT 时 %EBW 的积极变化相关。其次，我们要探讨是否客观使用中介分析，父母重新喂养行为的变化是 FBT-ARFID 的一个可能机制。目的 3：探索治疗结果的调节因素。为了进行一项充分有力的研究，100 名儿童（年龄 6-12 岁）将被随机分配到手动 FBT-ARFID 加医疗管理（n = 50）或手动非特殊治疗加医疗管理 (n=50)。主要评估（对治疗条件不知情）次要结局将在基线、1 个月、2 个月和 4 个月 (EOT) 时进行。