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

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

Study Description
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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.

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

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Validation of the Youth Version of the Alimetry Gut-Brain Wellbeing Survey: A Mental Health Scale for Patients With Chronic Gastroduodenal Symptoms
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Internal Consistency Reliability of the AGBW-Y total score and subscales [ Time Frame: Baseline ]
    Measured via Cronbach's alpha and item-total correlations

  2. 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)

  3. 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)

  4. 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)


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic gastroduodenal symptoms aged 12-17 years
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06394154


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

Sponsors and Collaborators
Greg O'Grady
University of Auckland, New Zealand
More Information
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Responsible Party: Greg O'Grady, Professor, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT06394154    
Other Study ID Numbers: AGBW-Y_Val
First Posted: May 1, 2024    Key Record Dates
Last Update Posted: May 2, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroparesis
Gastrointestinal Diseases
Digestive System Diseases
Rumination Syndrome
Vomiting
Dyspepsia
Aerophagy
 Signs and Symptoms, Digestive
Stomach Diseases
Paralysis
Neurologic Manifestations
Feeding and Eating Disorders
Mental Disorders