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

基本信息

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
项目类别：
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

项目摘要

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.

抽象的在美国，有 50 万青少年患有饮食失调症，但只有 66 家获得认证的提供者。在全国范围内，基于家庭的治疗（FBT）是针对青少年饮食的一线循证治疗大多数家庭都不容易获得医疗服务，这种医疗服务提供者的短缺使大多数年轻患者无法获得医疗服务。护理无疑会导致这些疾病的慢性化和致命性。疾病通常首先与初级保健中的医疗保健系统接触，因此，装备。拥有有效手段治疗这些患者的初级保健提供者（PCP）有可能使护理民主化，提高早期干预率，并改善以家庭为基础的初级保健治疗。 (FBT-PC) 是一种由 PCP 在初级保健中使用 FBT 数据支持提供的新型干预措施。我们有几个研究目标（1）我们将最终确定 FB-PC 干预。 (2) 我们将为护理人员建立 FBT-PC 的可行性和可接受性，最后，(3) 我们将测试初步目标参与度。 FBT-PC 并确定它是否与提高护理人员的自我效能相关，并通过此机制，症状缓解定义为体重恢复至预期体重的 95%。我们的体重和饮食失调调查问卷社区标准的分数在 1 SD 以内。还提出（4）一个探索性目标来评估我们样本的基线特征，以确定针对谁 FBT-PC 干预是最有益的。为了实现所有目标，我们将完成一个开放案例系列（n =）。 6)，随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）进行限制性饮食患有 FBT-PC 疾病或符合标准 FBT 控制条件的家庭将参加最多 18 个家庭。开放案例系列的目标（目标 1）将包括开发以下工具： FBT-PC 培训和实施，包括治疗和培训方案以及忠诚度措施。可行性（目标 2）将通过招聘和保留的评估来评估。将使用混合方法对护理人员、患者和 PCP 就相关主题进行调查和访谈进行评估我们还将评估 FBT-PC 参与我们提议的程度。改变机制、护理人员自我效能、促进症状缓解（目标 3）。 FBT-PC 的计算目标为 ≥ 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，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大量评估 FBT-PC 与标准 FBT 有效性非劣性的实用临床试验。