Objectives: The aim of this pilot study was to investigate feasibility and preliminary efficacy of an intensive, manual-based behavioral feeding intervention for children with chronic food refusal and dependence on enteral feeding or oral nutritional formula supplementation.
Methods: Twenty children ages 13 to 72 months (12 boys and 8 girls) meeting criteria for avoidant/restrictive food intake disorder were randomly assigned to receive treatment for 5 consecutive days in a day treatment program (n = 10) or waitlist (n = 10). A team of trained therapists implemented treatment under the guidance of a multidisciplinary team. Parent training was delivered to support generalization of treatment gains. We tracked parental attrition and attendance, as well as therapist fidelity. Primary outcome measures were bite acceptance, disruptions, and grams consumed during meals.
Results: Caregivers reported high satisfaction and acceptability of the intervention. Three participants (1 intervention; 2 waitlist) dropped out of the study before endpoint. Of the expected 140 treatment meals for the intervention group, 137 (97.8%) were actually attended. The intervention group showed significantly greater improvements (P < 0.05) on all primary outcome measures (d = 1.03-2.11) compared with waitlist (d = -1.13-0.24). A 1-month follow-up suggested stability in treatment gains.
Conclusions: Results from this pilot study corroborate evidence from single-subject and nonrandomized studies on the positive effects of behavioral intervention. Findings support the feasibility and preliminary efficacy of this manual-based approach to intervention. These results warrant a large-scale randomized trial to test the safety and efficacy of this intervention.
Trial registration: ClinicalTrials.gov NCT00992589.