Feasibility of conducting a randomized clinical trial using family‐based treatment for avoidant/restrictive food intake disorder

Abstract

Treatments for avoidant/restrictive food intake disorder (ARFID) lack strong empirical support. There is a critical need to conduct adequately powered studies to identify effective treatments for ARFID. As a first step, the primary aim of this study was to assess the feasibility of conducting a randomized clinical trial (RCT) comparingFamily-based Treatment for ARFID (FBT-ARFID) to usual care (UC). The primary outcomes were recruitment, attrition, suitability, and expectancy rates. The secondary aim was to assess changes in percent estimated body weight, eating related psychopathology, and parental self-efficacy from baseline to end of treatment/UC period in both groups. Recruitment rates were 1.87 per month; 28 children with ARFID and their families were randomized and attrition rate was 21%. Therapeutic suitability and expectancy rating suggested that FBT-ARFID was acceptable to families. Effect size (ES) differences on measures of weight and clinical severity were moderate to large, favoring FBT-ARFID over UC. Parental self-efficacy improvement also demonstrated a large ES favoring FBT-ARFID, which was correlated with improvements in ARFID symptoms. There is a research gap between our knowledge base on how to treat children with ARFID and clinical need. The data presented suggest that an RCT comparing FBT-ARFID and UC is feasible to conduct. K E Y W O R D Savoidant restrictive food intake disorder, family-based treatment

Cognitive‐behavioral therapy for avoidant/restrictive food intake disorder: Feasibility, acceptability, and proof‐of‐concept for children and adolescents

“…Despite data suggesting that ARFID is prevalent and impairing, there is little evidence to guide treatment. Only three small randomized controlled trials have been published, and all have focused on young children ages 13 months to 12 years (Lock et al, 2019a; Sharp et al, 2016; Sharp et al, 2017). Published research on the treatment of older children and adolescents is limited to retrospective chart reviews (Bryson, Scipioni, Essayli, Mahoney, & Ornstein, 2018; Makhzoumi et al, 2019), case studies (Thomas, Brigham, Sally, Hazen, & Eddy, 2017), and case series (Dumont, Jansen, Kroes, de Haan, & Mulkens, 2019; Rienecke, Drayton, Richmond, & Mammel, 2020).…”

“…For example, a case series of 11 children and adolescents ages 10–18 years found that cognitive‐behavioral therapy (CBT) delivered in an intensive day‐hospital format resulted in significant reductions in ARFID symptoms (Dumont et al, 2019). Similarly, a randomized controlled trial ( n = 28) of children ages 5–12 years highlighted the feasibility of outpatient family‐based treatment (FBT) in comparison to usual care (Lock et al, 2019a). Although some of these emerging therapies for older children and adolescents have been briefly outlined in book chapters (Fitzpatrick, Forsberg, & Colborn, 2015) or journal articles (Dumont et al, 2019; Lock et al, 2019b), none have yet been comprehensively described in treatment manuals that could facilitate empirical testing or dissemination.…”

Recent advances in therapies for eating disorders

“…Empirical data indicate that the model can be formulated to fit diagnoses, with promising results 10 . FBT for adolescents has been studied across a variety of contexts 15– 22 and multiple diagnoses 14, 24, 26 with favorable results, underscoring its clinical utility in young patients. Medication trials have led to the FDA approval of lisdexamfetamine for the treatment of BED 48 , and there is promise for olanzapine as an adjunctive treatment for weight gain in AN 49– 54 .…”

“…A feasibility study was also conducted by Lock et al . 26 of 28 patients with ARFID who were enrolled in either FBT or TAU to examine the appropriateness of conducting an RCT as well as differences in effect size between groups on clinical outcomes. In terms of weight gain, researchers found that both underweight and normal-weight patients gained more weight in FBT-ARFID (Cohen’s d = –0.90 and –0.69, respectively) than in TAU.…”

SPACE‐ARFID: A pilot trial of a novel parent‐based treatment for avoidant/restrictive food intake disorder

“…Although psychosocial interventions for childhood ARFID commonly acknowledge the importance of parental involvement in both maintaining the eating disorder and in facilitating change, and some include a parent component (e.g., Dumont et al, 2019; Eckhardt et al, 2019; Lock, Sadeh‐Sharvit, & L'Insalata, 2019), most interventions are child‐centered. An exception is the Picky Eaters Clinic, a parent‐only outpatient group behavioral treatment, that was evaluated in an open trial (7 groups; 2–4 families in each group; N = 21, ages 4–11 years).…”