Functional Gastrointestinal DisordersNCT06394154
Validation of a Mental Health Scale for Young People With Chronic Stomach Symptoms
An observational study of Functional Gastrointestinal Disorders and Gastroparesis, run by Greg O'Grady.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Functional Gastrointestinal Disorders, Gastroparesis, Vomiting; Cyclical
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with chronic gastroduodenal symptoms aged 12-17 years
Who may be able to join
- 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
Who cannot join
- Patients with self-induced vomiting
- Patients with an eating disorder
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Validation of the Youth Version of the Alimetry Gut-Brain Wellbeing Survey: A Mental Health Scale for Patients With Chronic Gastroduodenal Symptoms
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.
Read the detailed description
There is currently a lack of validated questionnaires developed to assess mental health within patients with chronic stomach symptoms. Our team has therefore developed and validated a new mental health scale for patients with gastroduodenal symptoms, the Alimetry® Gut-Brain Wellbeing (AGBW) Survey.
However, the AGBW Survey was developed and validated for patients aged 18 years and over. Therefore, the Alimetry® Gut-Brain Wellbeing Survey- Youth Version (AGBW- Y) was developed for use in patients with chronic gastroduodenal symptoms aged 12-17 years. This scale is adapted from the adult AGBW Survey, with more appropriate wording for this age group.
This study will distribute an anonymous, online survey to adolescent patients with chronic gastroduodenal symptoms aged 12-17 years. This survey will ask questions about a patient's general demographics, gastrointestinal symptoms, and mental health in order to assess the validity and reliability of the AGBW-Y.
- Conditions
- Functional Gastrointestinal Disorders, Gastroparesis, Vomiting; Cyclical, Nausea, Vomiting, Rumination Syndrome
- Medical subject headings
- Gastrointestinal Diseases, Gastroparesis, Familial cyclic vomiting syndrome, Nausea, Vomiting, Rumination Syndrome, Aerophagy, Dyspepsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal Consistency Reliability of the AGBW-Y total score and subscales
Measured via Cronbach's alpha and item-total correlations
Measured: Baseline
Convergent Validity of the AGBW-Y total score and subscales
Pearson's correlation coefficients between the AGBW-Y total score and subscales and the Patient Health Questionnaire for Adolescents (PHQ-A), the Generalized Anxiety Disorder- 7 (GAD-7), the PROMIS Pediatric Psychological Stress Experiences Short Form 8a (PPSE), the Depression Anxiety and Stress Scale Youth Version (DASS-Y), and the Kessler Psychological Distress Scale (K10)
Measured: Baseline
Divergent Validity of the AGBW-Y total score and subscales
Pearson's correlation coefficients between the AGBW-Y total score and subscales and the Big Five Questionnaire for Children (BFQ-C) energy/extraversion subscale and the the Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
Measured: Baseline
Concurrent Validity of the AGBW-Y total score and subscales
Pearson's correlation coefficients between the AGBW-Y total score and subscales and the Pediatric Quality of Life Inventory 4.0 (PedsQL)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study startMay 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Greg O'Grady
- Sponsor type
- University, hospital or other
- Collaborators
- University of Auckland, New Zealand
- Responsible party
- Sponsor-investigator, Greg O'Grady, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394154
- Sponsor's protocol ID
- AGBW-Y_Val
- Status last verified
- Apr 2024
- First submitted
- 28 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Law M, Humphrey G, Pickering I, Schamberg G, Varghese C, Du P, Daker C, Mousa H, Gharibans A, O'Grady G, Andrews CN, Calder S. Validation of the youth version of the Alimetry(R) Gut-Brain Wellbeing Survey: a mental health scale for young people with chronic gastroduodenal symptoms. World J Pediatr. 2026 Apr;22(4):465-476. doi: 10.1007/s12519-026-01027-4. Epub 2026 Apr 29.
PubMed 42056628
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Youth Version of the Alimetry Gut-Brain Wellbeing Survey: A Mental Health Scale for Patients With Chronic Gastroduodenal Symptoms
- ClinicalTrials.gov ID
- NCT06394154
- Acronym / sponsor ID
- AGBW-Y_Val
- Conditions
- Functional Gastrointestinal Disorders, Gastroparesis, Vomiting; Cyclical, Nausea, Vomiting, Rumination Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Greg O'GradyUniversity, hospital or other
- Collaborators
- University of Auckland, New Zealand
- Study start
- May 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 1 May 2024 (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.
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.
Detailed description
There is currently a lack of validated questionnaires developed to assess mental health within patients with chronic stomach symptoms. Our team has therefore developed and validated a new mental health scale for patients with gastroduodenal symptoms, the Alimetry® Gut-Brain Wellbeing (AGBW) Survey.
However, the AGBW Survey was developed and validated for patients aged 18 years and over. Therefore, the Alimetry® Gut-Brain Wellbeing Survey- Youth Version (AGBW- Y) was developed for use in patients with chronic gastroduodenal symptoms aged 12-17 years. This scale is adapted from the adult AGBW Survey, with more appropriate wording for this age group.
This study will distribute an anonymous, online survey to adolescent patients with chronic gastroduodenal symptoms aged 12-17 years. This survey will ask questions about a patient's general demographics, gastrointestinal symptoms, and mental health in order to assess the validity and reliability of the AGBW-Y.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with chronic gastroduodenal symptoms aged 12-17 years
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with self-induced vomiting
- Patients with an eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Internal Consistency Reliability of the AGBW-Y total score and subscales
Time frame: Baseline
Measured via Cronbach's alpha and item-total correlations
Convergent Validity of the AGBW-Y total score and subscales
Time frame: Baseline
Pearson's correlation coefficients between the AGBW-Y total score and subscales and the Patient Health Questionnaire for Adolescents (PHQ-A), the Generalized Anxiety Disorder- 7 (GAD-7), the PROMIS Pediatric Psychological Stress Experiences Short Form 8a (PPSE), the Depression Anxiety and Stress Scale Youth Version (DASS-Y), and the Kessler Psychological Distress Scale (K10)
Divergent Validity of the AGBW-Y total score and subscales
Time frame: Baseline
Pearson's correlation coefficients between the AGBW-Y total score and subscales and the Big Five Questionnaire for Children (BFQ-C) energy/extraversion subscale and the the Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
Concurrent Validity of the AGBW-Y total score and subscales
Time frame: Baseline
Pearson's correlation coefficients between the AGBW-Y total score and subscales and the Pediatric Quality of Life Inventory 4.0 (PedsQL)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Derived from this study: PubMed 42056628Law M, Humphrey G, Pickering I, Schamberg G, Varghese C, Du P, Daker C, Mousa H, Gharibans A, O'Grady G, Andrews CN, Calder S. Validation of the youth version of the Alimetry(R) Gut-Brain Wellbeing Survey: a mental health scale for young people with chronic gastroduodenal symptoms. World J Pediatr. 2026 Apr;22(4):465-476. doi: 10.1007/s12519-026-01027-4. Epub 2026 Apr 29.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Gastrointestinal Disorders and Gastroparesis, run by Greg O'Grady.
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 2 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: status not confirmed, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikaela Law, PhD (+64 9 923 9820, m.law@auckland.ac.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal Consistency Reliability of the AGBW-Y total score and subscales (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06394154, which also lists 1 linked publication.
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 2 May 2024.