Feeding Disorders in Children (FEEDING)

Feeding Disorders in Pediatric Age: Effects of an Interdisciplinary Intervention

Pediatric Feeding Disorders (PFDs) are conditions characterized by persistent difficulties in food intake, commonly manifesting as food selectivity, food refusal, and dysfunctional mealtime behaviors. Their prevalence in the general pediatric population ranges from 3% to 10%, with substantially higher rates reported among children with neurodevelopmental disorders. The impact of PFDs extends beyond growth and nutritional status, affecting cognitive and emotional development as well as the well-being of the entire family system. Although several treatment models have been proposed, scientific evidence supporting outpatient interventions remains limited and Italy-specific studies are lacking. Moreover, despite the availability of standardized assessment tools, feeding-related outcomes are not yet systematically addressed within outpatient clinical practice for children with neurodevelopmental disorders.

The present study aims to evaluate whether an interdisciplinary intervention protocol involving a psychologist, a speech and language therapist (SLP), and a Neuro and Psychomotor Therapist of Developmental Age (TNPEE) can improve food variety and reduce dysfunctional mealtime behaviors in this population. The study is designed as a pilot randomized controlled trial developed across five sequential phases: participant enrollment and screening using the Montreal Children's Hospital Feeding Scale (MCH-FS); baseline standardized assessment (T0) using the Pediatric Eating Assessment Tool (PediEAT) and the Short Sensory Profile (SSP); random allocation of participants to an experimental group or a control group; delivery of the interdisciplinary intervention exclusively to the experimental group; and a final standardized assessment conducted six weeks later (T1) to evaluate changes over time and between groups.

This pilot study primarily aims to assess feasibility and to estimate the variability of outcome measures; therefore, no formal sample size or power calculation was performed. The planned enrollment of 12 participants per group was determined based on feasibility considerations and in line with CONSORT recommendations for pilot trials. The proposed protocol seeks to address current gaps in the literature by systematically targeting feeding-related outcomes through an explicitly interdisciplinary approach that integrates psychological, speech and language, and neuropsychomotor perspectives in the management of PFD.

Study Overview

• Status: Recruiting
• Conditions: ARFID; Feeding Disorder; Neurodevelopmental Disorder (Diagnosis)
• Intervention / Treatment: Other: Interdisciplinary intervention; Other: Standard rehabilitation program

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Cavalieri, SLP; Phone Number: +39 0652253440; Email: elena.cavalieri@unicatt.it
• Study Contact Backup: Name: Lucia Gatta; Phone Number: +39 0652253440; Email: lucia.gatta@sanraffaele.it

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00166
      • Recruiting
      • IRCCS San Raffaele
      • Contact: Elena Cavalieri, SLP; Phone Number: +39 0652253440; Email: elena.cavalieri@unicatt.it
      • Contact: Lucia Gatta; Phone Number: +39 0652253440; Email: lucia.gatta@sanraffaele.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 2 and 7 years.
• Diagnosis of a neurodevelopmental disorder according to DSM-5 criteria.
• Presence of a feeding disorder.

Exclusion Criteria:

• Presence of respiratory, cardiovascular, gastrointestinal, or neurological conditions preventing oral feeding.
• Insufficient caregiver proficiency in the Italian language, such as to compromise completion of the questionnaires.
• Children who are undergoing a different feeding intervention at the time of screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Rehabilitation	Other: Standard rehabilitation program; Participants in the control group receive standard multidisciplinary rehabilitation as provided in an ex art. 26 accredited rehabilitation center. The rehabilitation program includes speech and language therapy, neuro and psychomotor therapy (TNPEE), physiotherapy, and psychological support, delivered according to an individualized rehabilitation plan. Treatments are provided by licensed therapists in accordance with routine clinical practice.The frequency and duration of each intervention are defined by the individualized rehabilitation plan and reflect standard clinical practice.
Experimental: Interdisciplinary Feeding Intervention	Other: Interdisciplinary intervention; Each patient undergoes 12 individual therapy sessions (twice weekly over 6 consecutive weeks), each lasting 30 minutes. Sessions are conducted by a psychologist, who provides parent training, and by a speech-language pathologist (SLP) and a Neuro and Psychomotor Therapist of Developmental Age (TNPEE), who deliver direct intervention to the child in the presence of the caregiver. The psychologist establishes a feeding routine and educates the caregiver on emotional and behavioral management during mealtimes. The SLP and TNPEE implement play-based sensory activities and a specific exercise protocol to enhance oral sensitivity and strengthen orofacial musculature. From the second session onward, the food diary is monitored and caregivers receive guidance for the gradual introduction of new foods at home. At each session, the interdisciplinary team monitors progress based on food diary data and caregiver reports and adapts the intervention to the child's needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Eating Assessment Tool (PediEAT) Total Score	The Pediatric Eating Assessment Tool (PediEAT) is a standardized parent-report questionnaire consisting of 78 items assessing observable feeding-related symptoms in children aged 6 months to 7 years. Each item is rated on a 6-point Likert scale (0 to 5). The total score ranges from 0 to 390, with higher scores indicating greater feeding-related concern (worse outcome).	Baseline and immediately post-intervention (6 weeks)

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele Roma

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): February 20, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Avoidant Restrictive Food Intake Disorder; Disease; Neurodevelopmental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: 434/SR/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No