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.
