Scalable, Clinician-Supervised Generative-AI Food-Chaining Assistant for Pediatric ARFID
125 participantsStarted 2025-06-15
Plain-language summary
Children with Avoidant/Restrictive Food Intake Disorder (ARFID) often lack access to specialty dietitians, and scalable nutritional guidance/food chaining tools are currently not available. The investigators will evaluate a web-based, clinician-supervised, generative-AI assistant that produces individualized food-chaining plans.
Develop an AI assistant that generates ≥15 allergy-safe, evidence-based chaining steps per participant and meets ≥90 % expert agreement for safety/appropriateness.
Validate the assistant against gold-standard clinician recommendations (Cohen's κ ≥ 0.80).
Test clinical impact in a three-month pilot RCT (n = 96) by comparing change in Nine-Item ARFID Screen (NIAS) scores between intervention and usual-care groups.
Hypothesis: AI-generated plans will reduce NIAS scores by ≥3 points relative to controls.
Who can participate
Age range
3 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children must be aged 3-17 years
* Children must have caregiver- or participant-reported DSM-5 ARFID diagnosis and/or EDYQ-screen-positive Avoidant Restrictive Food Intake Disorder
* English proficiency.
Exclusion Criteria:
* Lack of English proficiency \[As there is no validated non-English version of the NIAS, we must exclude caregivers who do not have English proficiency\]
* Participants must not have been previously treated at Boston Children's for ARFID
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.