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

NCT06394154 | Not Yet Recruiting

• 1 other identifier: AGBW-Y_Val
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Internal Consistency Reliability of the AGBW-Y total score and subscales

  Measured via Cronbach's alpha and item-total correlations

  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)

  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)

  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)

  Baseline

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic gastroduodenal symptoms aged 12-17 years

You may qualify if:

• 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

You may not qualify if:

• Patients with self-induced vomiting
• Patients with an eating disorder

Sponsors & Collaborators

• Greg O'Grady: lead
• University of Auckland, New Zealand: collaborator

MeSH Terms

Conditions

Gastrointestinal Diseases; Gastroparesis; Familial cyclic vomiting syndrome; Nausea; Vomiting; Rumination Syndrome; Aerophagy; Dyspepsia

Condition Hierarchy (Ancestors)

Digestive System Diseases; Stomach Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Mental Disorders

Central Study Contacts

Mikaela Law, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 1, 2024
• Study Start: May 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04