Feeding Disorders in Children

NCT07431671 | Recruiting

• 1 other identifier: 434/SR/25
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Feeding Disorder; ARFID; Neurodevelopmental Disorder (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Interdisciplinary Feeding Intervention

EXPERIMENTAL

Other: Interdisciplinary intervention

Standard Rehabilitation

ACTIVE COMPARATOR

Other: Standard rehabilitation program

Interventions

Interdisciplinary intervention OTHER

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.

Interdisciplinary Feeding Intervention

Standard rehabilitation program OTHER

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.

Standard Rehabilitation

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead

Study Sites (1)

IRCCS San Raffaele

Roma, RM, 00166, Italy

RECRUITING

MeSH Terms

Conditions

Neurodevelopmental Disorders; Disease; Feeding and Eating Disorders; Avoidant Restrictive Food Intake Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Central Study Contacts

Elena Cavalieri, SLP

CONTACT

+39 0652253440; elena.cavalieri@unicatt.it

Lucia Gatta

CONTACT

+39 0652253440; lucia.gatta@sanraffaele.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 24, 2026
• Study Start: January 1, 2026
• Primary Completion: February 20, 2026
• Study Completion: February 28, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)