Evaluating the feasibility of a primary care-based treatment for restrictive eating disorders in children and adolescents

评估针对儿童和青少年限制性饮食失调的初级保健治疗的可行性

• 批准号: 10569776
• 负责人: Jocelyn Rebecca Lebow
• 金额: $ 23.85万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-15 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10569776
• 关键词: Address; Adolescent; Affect; Age; Ambulatory Care; American; Anorexia; Belief; Body Weight; Caregiver support; Caregivers; Caring; Case Series; Certification; Cessation of life; Characteristics; Child; Chronic; Clinic; Communities; Data; Democracy; Disease remission; Distance Learning; Early Intervention; Eating Disorders; Educational process of instructing; Effectiveness; Evaluation; Evidence based treatment; Family; Goals; Health Services Accessibility; Healthcare Systems; Intervention; Interview; Life; Link; Manuals; Measures; Medical; Mental disorders; Methodology; Methods; Nature; Outcome; Parents; Patient Care; Patient-Focused Outcomes; Patients; Perception; Pilot Projects; Play; Positioning Attribute; Pragmatic clinical trial; Preparation; Primary Care; Process; Protocols documentation; Provider; Questionnaires; Randomized; Randomized, Controlled Trials; Recording of previous events; Recovery; Reporting; Role; Sampling; Self Efficacy; Severities; Suicide; Survey Methodology; Symptoms; Testing; Training; United States; acceptability and feasibility; access disparities; arm; behavior change; comparison intervention; design; effective therapy; eligible participant; empowerment; evidence base; experience; family burden; feasibility testing; illness length; illness perceptions; improved; improved outcome; intervention delivery; meetings; mortality; novel; operation; participant enrollment; patient responsibilities; pediatric patients; pilot trial; pragmatic trial; primary care provider; primary care setting; recruit; reduce symptoms; restrictive eating; retention rate; rural setting; tool; tool development; treatment strategy; treatment trial; trend; weight restoration

ABSTRACT In the United States, half a million adolescents suffer from an eating disorder. With only 66 certified providers nationally, Family-Based Treatment (FBT), a first-line evidence-based treatment for adolescent eating disorders, is not readily available to most families. This provider shortage leaves most young patients without care and undoubtedly contributes to the chronicity and lethality of these conditions. Patients with eating disorders generally make their first contact with the healthcare system in primary care. As such, equipping primary care providers (PCPs) with effective means to treat these patients has potential to democratize care, improve rates of early intervention, and enhance patient outcomes. Family-Based Treatment for Primary Care (FBT-PC) is a novel intervention for delivery by a PCP in primary care that uses FBT strategies. Data support proof-of-concept for this adaptation. We have several study aims. (1) We will finalize the FB-PC intervention through an open case series. (2) We will establish the feasibility and acceptability of FBT-PC for caregivers, patients, and PCPs in a pilot randomized controlled trial. Finally, (3) we will test preliminary target engagement of FBT-PC and determine whether it is associated with improved caregiver self-efficacy and, through this mechanism, symptom remission. Remission will be defined as weight restoration to 95% of expected body weight and a score within 1 SD of community norms on the Eating Disorder Examination-Questionnaire. We also propose (4) an exploratory aim to evaluate baseline characteristics of our sample to determine for whom the FBT-PC intervention is most beneficial. To accomplish all aims we will complete an open case series (n = 6), followed by a pilot trial in which we will randomly assign 40 patients (ages 7-18 years) with restrictive eating disorders and their caregiver(s) to FBT-PC or a control condition of standard FBT. Families will attend up to 18 sessions over 6 months. Goals from the open case series (Aim 1) will include the development of tools for FBT-PC training and implementation, including treatment and training protocols and fidelity measures. Feasibility (Aim 2) will be assessed through an evaluation of recruitment and retention. Acceptability (Aim 2) will be evaluated using mixed methods surveys and interviews of caregivers, patients and PCPs on the topics of tolerability, fit, and burden. We will also assess the degree to which FBT-PC engages our proposed mechanism of change, caregiver self-efficacy, to facilitate symptom remission (Aim 3). Effect sizes will be calculated for FBT-PC with a goal of ≥ 0.5, comparable with those found in FBT trials. Finally, baseline sample characteristics (Exploratory Aim) will be assessed including caregiver perceptions about their child’s illness, referral method, length of illness, and symptom severity. Once we have established feasibility, acceptability, and target engagement of the FBT-PC intervention, we intend to use these findings in support of a large pragmatic clinical trial to evaluate the noninferiority of effectiveness of FBT-PC versus standard FBT.

摘要 在美国，有50万青少年患有进食障碍。只有66家认证提供商 在全国范围内，家庭治疗(FBT)是青少年饮食的一线循证治疗方法 对于大多数家庭来说，这种疾病并不容易获得。这种提供者短缺让大多数年轻患者失去了 而且无疑会导致这些疾病的长期性和致命性。患者进食 障碍通常是在初级保健中第一次接触到医疗保健系统。因此，装备 拥有治疗这些患者的有效手段的初级保健提供者(PCP)有可能使保健民主化， 提高早期干预率，改善患者预后。以家庭为基础的初级保健治疗 (FBT-PC)是一种新的干预措施，由初级保健中的PCP使用FBT策略进行分娩。数据支持 这一改编的概念验证。我们有几个研究目标。(1)我们将最终确定FB-PC干预 通过一个公开的案件系列。(2)我们将确定FBT-PC对照顾者的可行性和可接受性， 在一项先导性随机对照试验中，患者和PCP。最后，(3)我们将测试初步目标交战 并确定它是否与照顾者自我效能的提高有关，并通过这一点 机制，症状缓解。缓解将被定义为体重恢复到预期体重的95% 体重和进食障碍检查问卷的得分在社区常模的1 SD以内。我们 还提出了一个探索性目标，以评估我们样本的基线特征，以确定为谁服务 FBT-PC的干预是最有益的。为了实现所有目标，我们将完成一个公开案例系列(n= 6)，然后我们将随机分配40名限制饮食的患者(7-18岁)进行试点试验 精神障碍患者及其照顾者(S)对儿童行为障碍量表或标准儿童行为量表进行对照。最多将有18个家庭参加 疗程超过6个月。开放案例系列(目标1)的目标将包括开发用于 FBT-PC培训和实施，包括治疗和培训方案以及保真度措施。 将通过对招聘和留用的评估来评估可行性(目标2)。可接受性(目标2) 将使用混合方法对照顾者、患者和初级保健医生进行评估 耐受性、适合性和负担。我们还将评估FBT-PC在多大程度上参与我们提议的 改变机制，照顾者自我效能，以促进症状缓解(目标3)。效果大小将为 对目标为≥0.5的自由贸易壁垒-个人计算机进行计算，与在自由贸易壁垒试验中发现的结果相当。最后，基线样本 特征(探索性目标)将被评估，包括照顾者对他们孩子疾病的看法， 转诊方法、病程和症状严重程度。一旦我们确定了可行性、可接受性、 和目标参与的FBT-PC干预，我们打算利用这些发现来支持一个大的 评估FBT-PC与标准FBT疗效非劣势的实用临床试验。