Aarnio-Peterson Claire M, Mara Constance A, Modi Avani C, Matthews Abigail, Le Grange Daniel, Shaffer Anne
Cincinnati Children's Hospital Medical Center, Division of Behavioral Medicine and Clinical Psychology, University of Cincinnati College of Medicine, 3333 Burnet Avenue, Cincinnati, OH, 45229, USA.
Department of Psychiatry and Behavioral Sciences, University of California, 401 Parnassus Ave., San Francisco, CA, 94143, USA.
Contemp Clin Trials Commun. 2023 Mar 18;33:101118. doi: 10.1016/j.conctc.2023.101118. eCollection 2023 Jun.
This article characterizes the design, recruitment, methodology, participant characteristics, and preliminary feasibility and acceptability of the Families Ending Eating Disorders (FEED) open pilot study. FEED augments family-based treatment (FBT) for adolescents with anorexia nervosa (AN) and atypical anorexia nervosa (AAN) with an emotion coaching (EC) group for parents (i.e., FBT + EC). We targeted families high in critical comments and low warmth (assessed by the Five-Minute Speech Sample), known predictors of poor response in FBT. Eligible participants included adolescents initiating outpatient FBT, diagnosed with AN/AAN, ages 12-17, with a parent high in critical comments/low in warmth. The first phase of the study was an open pilot which demonstrated feasibility and acceptability of FBT + EC. Thus, we proceeded with the small randomized controlled trial (RCT). Eligible families were randomized to either 10 weeks of FBT + EC parent group treatment or the 10- week parent support group (control condition). The primary outcomes were parent critical comments and parental warmth, while our exploratory outcome was adolescent weight restoration. Novel aspects of the trial design (e.g., specifically targeting typical treatment non-responders), as well as recruitment and retention challenges in the context of the COVID-19 pandemic are discussed.
本文介绍了“终结饮食失调家庭（FEED）”开放性试点研究的设计、招募、方法、参与者特征以及初步的可行性和可接受性。FEED在针对神经性厌食症（AN）和非典型神经性厌食症（AAN）青少年的基于家庭的治疗（FBT）基础上，为家长增加了一个情绪辅导（EC）小组（即FBT + EC）。我们将目标对准那些批判性评论多且温情少的家庭（通过五分钟言语样本评估），这些是FBT治疗效果不佳的已知预测因素。符合条件的参与者包括开始接受门诊FBT治疗、被诊断为AN/AAN、年龄在12至17岁且有一位批判性评论多/温情少的家长的青少年。研究的第一阶段是开放性试点，证明了FBT + EC的可行性和可接受性。因此，我们开展了小型随机对照试验（RCT）。符合条件的家庭被随机分为接受为期10周的FBT + EC家长组治疗或为期10周的家长支持组（对照条件）。主要结果是家长的批判性评论和家长的温情，而我们的探索性结果是青少年体重恢复。讨论了试验设计的新颖之处（例如，专门针对典型的治疗无反应者），以及在新冠疫情背景下的招募和留用挑战。
