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

• ClinicalTrials.gov Identifier: NCT06394154
• Recruitment Status: Not yet recruiting
• First Posted: May 1, 2024
• Last Update Posted: May 2, 2024
• Sponsor: Greg O'Grady
• Collaborator: University of Auckland, New Zealand
• Information provided by (Responsible Party): Greg O'Grady, University of Auckland, New Zealand

Tracking Information

• First Submitted Date: April 28, 2024
• First Posted Date: May 1, 2024
• Last Update Posted Date: May 2, 2024
• Estimated Study Start Date: May 2024
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 28, 2024)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Validation of a Mental Health Scale for Young People With Chronic Stomach Symptoms
• Official Title: Validation of the Youth Version of the Alimetry Gut-Brain Wellbeing Survey: A Mental Health Scale for Patients With Chronic Gastroduodenal Symptoms
• 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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with chronic gastroduodenal symptoms aged 12-17 years

Condition

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

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 28, 2024): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2024
• Estimated Primary Completion Date: September 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Mikaela Law, PhD; +64 9 923 9820; m.law@auckland.ac.nz

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06394154
• Other Study ID Numbers: AGBW-Y_Val
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Greg O'Grady, University of Auckland, New Zealand
• Original Responsible Party: Same as current
• Current Study Sponsor: Greg O'Grady
• Original Study Sponsor: Same as current
• Collaborators: University of Auckland, New Zealand
• Investigators: Not Provided
• PRS Account: University of Auckland, New Zealand
• Verification Date: April 2024