Neurodevelopmental Disorder (Diagnosis)FEEDINGNCT07431671
Feeding Disorders in Children
A study testing Interdisciplinary intervention and Standard rehabilitation program in people with Neurodevelopmental Disorder (Diagnosis) and Feeding Disorder, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Neurodevelopmental Disorder (Diagnosis), Feeding Disorder, ARFID
- What is being tested?
- Interdisciplinary intervention and Standard rehabilitation program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2026to 28 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 2 and 7 years.
- Diagnosis of a neurodevelopmental disorder according to DSM-5 criteria.
- Presence of a feeding disorder.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Roma, RM, 00166
Elena Cavalieri, SLP, +39 0652253440, elena.cavalieri@unicatt.it
Lucia Gatta, +39 0652253440, lucia.gatta@sanraffaele.it
About this study
Official title: 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.
- Being tested
- Interdisciplinary intervention, Standard rehabilitation program
- Medical subject headings
- Neurodevelopmental Disorders, Disease, Feeding and Eating Disorders, Avoidant Restrictive Food Intake Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary interventionOther
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.
Standard rehabilitation programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Interdisciplinary Feeding Intervention | Experimental | Not described Receives: Other: Interdisciplinary intervention |
| Standard Rehabilitation | Active comparator | Not described Receives: Other: Standard rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and immediately post-intervention (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start1 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental Disorder (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431671
- Sponsor's protocol ID
- 434/SR/25
- Acronym
- FEEDING
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Disorders in Pediatric Age: Effects of an Interdisciplinary Intervention
- ClinicalTrials.gov ID
- NCT07431671
- Acronym / sponsor ID
- FEEDING / 434/SR/25
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary Feeding Intervention | Experimental | Other: Interdisciplinary intervention |
| Standard Rehabilitation | Active comparator | Other: Standard rehabilitation program |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 2 and 7 years.
- Diagnosis of a neurodevelopmental disorder according to DSM-5 criteria.
- Presence of a feeding disorder.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interdisciplinary interventionEach 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. | Other | Interdisciplinary Feeding Intervention |
| Standard rehabilitation programParticipants 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. | Other | Standard Rehabilitation |
Primary outcome
Pediatric Eating Assessment Tool (PediEAT) Total Score
Time frame: Baseline and immediately post-intervention (6 weeks)
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary intervention and Standard rehabilitation program in people with Neurodevelopmental Disorder (Diagnosis) and Feeding Disorder, run by IRCCS San Raffaele Roma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Cavalieri, SLP (+39 0652253440, elena.cavalieri@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Eating Assessment Tool (PediEAT) Total Score (time frame: Baseline and immediately post-intervention (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.