Protocol for a randomized clinical trial for Avoidant Restrictive Food Intake Disorder (ARFID) in low-weight youth

Background Avoidant Restrictive Food Intake Disorder (ARFID) is an eating disorder recently added to the Diagnostic and Statistical Manual, 5th Edition (DSM-5) that involves nutritional, developmental, and/or psychosocial impairment, and often presents with a lack of interest in eating, sensory-related eating concerns, and/or fear of adverse consequences related to eating. There is limited evidence on treatments for ARFID, and in particular, treatments for children in the outpatient setting. Pilot data suggest that Family-Based Treatment (FBT) modified for ARFID is efficacious, and that improvements in parental self-efficacy may be the mechanism behind its success. This manuscript describes a study protocol seeking to confirm these preliminary findings through an adequately powered, randomized clinical trial (RCT). METHODS: This trial will randomize 100 children ages 6-12 years old who meet DSM-5 criteria for ARFID and their families to receive either 14 telehealth sessions of FBT-ARFID (n = 50) or a manualized Psychoeducational Motivation Therapy (PMT) treatment (n = 50), an individual therapy addressing the child's understanding of the problems ARFID is causing and promoting non-behavioral motivation and exploration of changing their eating patterns. Masked assessments will be conducted at baseline, one and two months within treatment, end-of-treatment, and six-month follow-up. Primary outcomes include change in body weight, parental self-efficacy, and parent feeding behaviors between baseline and end-of-treatment. CONCLUSIONS: The results of this RCT will advance our understanding of effective treatments for low-weight ARFID in youth.