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50万青少年患有饮食失调症。只有66家认证供应商 在全国范围内，以家庭为基础的治疗（FBT），青少年饮食的一线循证治疗 疾病，是不容易获得的大多数家庭。这种供应商短缺使大多数年轻患者无法 护理和无疑有助于慢性和致命的这些条件。进食患者 疾病通常在初级保健中首次与保健系统接触。因此，装备 具有治疗这些患者的有效手段的初级保健提供者（PCP）具有使保健民主化的潜力， 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）是一种新型的干预措施，用于初级保健中使用FBT策略的PCP分娩。数据支持 这一适应性的概念验证。我们有几个学习目标。(1)我们将完成FB-PC的干预 通过一系列公开的案件(2)我们将为护理人员确定FBT-PC的可行性和可接受性， 患者和PCP的初步随机对照试验。最后，（3）我们将测试初步的目标接合 的FBT-PC，并确定它是否与提高照顾者的自我效能，并通过这一点， 机制，症状缓解。缓解定义为体重恢复至预期体重的95% 体重和进食障碍检查问卷的社区规范的1 SD内的分数。我们 我还提出（4）一个探索性的目标，以评估我们的样本的基线特征，以确定谁 FBT-PC干预最有益。为了实现所有目标，我们将完成一个开放病例系列（n = 6），然后进行一项试点试验，我们将随机分配40名患者（年龄7-18岁）， 疾病和他们的照顾者对FBT-PC或标准FBT的控制条件。家庭将参加多达18 6个月以上的会议。开放案例系列的目标（目标1）将包括开发工具， FBT-PC培训和实施，包括治疗和培训方案以及保真度措施。 可行性（目标2）将通过对招聘和留用的评价进行评估。可接受性（目标2） 将使用混合方法调查和对护理人员、患者和PCP的访谈进行评估 耐受性、适应性和负担。我们还将评估FBT-PC在多大程度上参与我们的建议， 改变机制，照顾者自我效能，以促进症状缓解（目的3）。效应量将是 计算FBT-PC，目标≥ 0.5，与FBT试验中发现的结果相当。最后，基线样本 将评估特征（探索性目标），包括护理人员对其孩子疾病的看法， 转诊方法、病程长短和症状严重程度。一旦我们确定了可行性，可接受性， 和FBT-PC干预的目标参与，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相比有效性的非劣效性的实用临床试验。