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

Not yet recruiting

• Conditions: Aerophagy; Gastroparesis; Nausea; Vomiting; Functional Gastrointestinal Disorders; Vomiting; Cyclical; Rumination Syndrome; Dyspepsia

• Registration Number: NCT06394154
• Lead Sponsor: Greg O'Grady

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-28
• Study First Submitted QC: 2024-04-28
• Last Update Submitted: 2024-04-30
• Study Start: 2024-05
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-02
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
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)
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)