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NCT06394154 Clinical Trial

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

Nausea Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06394154
Other study ID # AGBW-Y_Val
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date September 2024

Study information
Verified date April 2024
Source University of Auckland, New Zealand
Contact Mikaela Law, PhD
Phone +64 9 923 9820
Email m.law@auckland.ac.nz
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Greg O'Grady University of Auckland, New Zealand

Outcome
Type Measure Description Time frame Safety issue
Primary Internal Consistency Reliability of the AGBW-Y total score and subscales Measured via Cronbach's alpha and item-total correlations Baseline
Primary 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) Baseline
Primary 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) Baseline
Primary 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) Baseline
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