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

April 30, 2024 updated by: Greg O'Grady

Validation of the Youth Version of the Alimetry Gut-Brain Wellbeing Survey: A Mental Health Scale for Patients With Chronic Gastroduodenal Symptoms

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.

Study Overview

Status

Not yet recruiting

Conditions

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

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic gastroduodenal symptoms aged 12-17 years

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal Consistency Reliability of the AGBW-Y total score and subscales
Time Frame: Baseline
Measured via Cronbach's alpha and item-total correlations
Baseline
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)
Baseline
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)
Baseline
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)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Greg O'Grady

Collaborators

University of Auckland, New Zealand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

April 28, 2024

First Submitted That Met QC Criteria

April 28, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGBW-Y_Val

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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