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
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Digestive System Diseases
• Dyspepsia
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Gastroparesis
• Nausea
• Vomiting

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