Feeding Disorders in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interdisciplinary intervention, Standard rehabilitation program.
- Who it may be relevant to
- Registry conditions: Neurodevelopmental Disorder (Diagnosis), Feeding Disorder, ARFID. Basic parameters: 2 years — 7 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feeding Disorders in Pediatric Age: Effects of an Interdisciplinary Intervention
Overview
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.
Interventions
- 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 durin - 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
Primary outcome measures
- Pediatric Eating Assessment Tool (PediEAT) Total Score [Time frame: Baseline and immediately post-intervention (6 weeks)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- IRCCS San Raffaele — Roma
Identifiers
NCT: NCT07431671 · 434/SR/25