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

Validation of the Youth Version of the Alimetry Gut-Brain Wellbeing Survey: A Mental Health Scale for Patients With Chronic Gastroduodenal Symptoms

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06394154

Enrollment

100

Registered

2024-05-01

Start date

2024-05-31

Completion date

2024-09-30

Last updated

2024-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aerophagy, Dyspepsia, Functional Gastrointestinal Disorders, Gastroparesis, Nausea, Rumination Syndrome, Vomiting, Vomiting; Cyclical

Brief 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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Internal Consistency Reliability of the AGBW-Y total score and subscales	Baseline	Measured via Cronbach's alpha and item-total correlations
Convergent Validity of the AGBW-Y total score and subscales	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	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	Baseline	Pearson's correlation coefficients between the AGBW-Y total score and subscales and the Pediatric Quality of Life Inventory 4.0 (PedsQL)

Contacts

Primary ContactMikaela Law, PhD

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

Outcome results