UnknownNot Applicable

Validation of a Mental Health Scale for Young People With Chronic Stomach Symptoms

100 participantsStarted 2024-05

Plain-language summary

This study aims to validate the Alimetry® Gut-Brain Wellbeing Survey- Youth Version (AGBW-Y), a mental health scale developed for patients aged 12-17 years with chronic stomach symptoms.

Who can participate

Age range

12 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: * Aged 12-17 years * Able to read and write fluently in English * Meet the Rome IV criteria and/or have a self-reported previous clinical diagnosis for at least one of the following childhood gastroduodenal DGBIs: gastroparesis, cyclic vomiting syndrome, functional nausea, functional vomiting, rumination syndrome, aerophagia, or functional dyspepsia Exclusion Criteria: * Patients with self-induced vomiting * Patients with an eating disorder

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.

What they're measuring

Internal Consistency Reliability of the AGBW-Y total score and subscales

Timeframe: Baseline

Convergent Validity of the AGBW-Y total score and subscales

Timeframe: Baseline

Divergent Validity of the AGBW-Y total score and subscales

Timeframe: Baseline

Concurrent Validity of the AGBW-Y total score and subscales

Timeframe: Baseline

Trial details

NCT IDNCT06394154

SponsorGreg O'Grady

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09

Contact for this trial

Mikaela Law, PhD

+64 9 923 9820 m.law@auckland.ac.nz

View on ClinicalTrials.gov More Functional Gastrointestinal Disorders trials

Who can participate

Age range

12 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.

What they're measuring

Internal Consistency Reliability of the AGBW-Y total score and subscales

Timeframe: Baseline

Convergent Validity of the AGBW-Y total score and subscales

Timeframe: Baseline

Divergent Validity of the AGBW-Y total score and subscales

Timeframe: Baseline

Concurrent Validity of the AGBW-Y total score and subscales

Timeframe: Baseline