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

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

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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。只有66个认证提供商全国性的基于家庭的治疗（FBT），这是一种基于一线证据的青少年饮食大多数家庭不容易获得疾病。这个提供者的短缺使大多数年轻患者没有护理和无疑有助于这些疾病的慢性和致命性。饮食患者疾病通常是与初级保健中医疗系统的首次接触。因此，装备具有有效治疗这些患者的有效手段的初级保健提供者（PCP）有可能使护理民主化，提高早期干预的速度，并提高患者预后。基于家庭的初级保健治疗（FBT-PC）是一种新的干预措施，用于使用FBT策略的PCP在初级保健中提供。数据支持这种适应的概念证明。我们有一些研究目标。（1）我们将最终确定FB-PC干预通过一个开放式案例系列。（2）我们将确定FBT-PC对护理人员的可行性和可接受性，患者和PCP在试验中随机对照试验中。最后，（3）我们将测试初步目标参与 FBT-PC并确定它是否与改善的护理人员相关，并通过此机制，症状缓解。缓解将定义为重量恢复到预期身体的95％体重和在饮食失调检查问卷的社区规范的1个SD之内。我们也建议（4）探索性目的是评估样本的基线特征，以确定谁 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式案例系列（n = 6），然后进行试点试验，我们将随机分配40名患者（7-18岁），并进行限制性饮食疾病及其护理人员对FBT-PC或标准FBT的控制条件。家庭最多将参加18岁会议超过6个月。开放式案例系列的目标（AIM 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忠诚度测量。可行性（AIM 2）将通过评估招聘和保留率进行评估。可接受性（目标2）将使用混合方法调查以及对主题的护理人员，患者和PCP的访谈进行评估耐受性，适合和伯恩。我们还将评估FBT-PC参与我们建议的程度变化的机制，护理人员的自我效能感，促进符号缓解（AIM 3）。效应尺寸将是针对FBT-PC计算的目标≥0.5，与FBT试验中的目标相当。最后，基线样本将评估特征（探索目的），包括照顾者对孩子病的看法，转诊方法，疾病长度和症状严重程度。一旦我们确定了可行性，可接受性，以及FBT-PC干预的目标参与，我们打算使用这些发现来支持大型务实的临床试验评估了FBT-PC与标准FBT有效性的非效率。