GRANDCHILD
Using the Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) in Children With Cerebral Palsy: a Preliminary Validation Study
Sponsor study identifier
observational
26
1 country
2
Study Start
January 22, 2021
Actual (reported)Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study assesses the content validity of the PGSQ for parents/carer of children with cerebral palsy and GORD, including features such as readability, face validity and acceptability for completion. This will be done via 6 interviews, with the PGSQ being altered as identified as required. Reliability (test-retest) of the adapted version of the PGSQ being assessed with a sample of 20 parents/carers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 27, 2020
Actual (reported)March 3, 2020
Actual (reported)January 22, 2021
Actual (reported)December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Phase 1: Valid modified Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ)
Qualitative feedback on whether the Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) needs modification or is useful and appropriate for patents/carers of children with cerebral palsy and GORD.
1 day
Phase 2: Reliability of modified Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ)
2 weeks
Cohort of 6 parents/carers of children with cerebral palsy and GORD, who will be interviewed regarding the content validity of the PGSQ when used to assess symptoms of GORD in children with cerebral palsy.
Cohort of 20 parents/carers of children with cerebral palsy and GORD, who will review and complete the adapted version of the PGSQ (post Phase 1) at two time points, two weeks apart.
Parents/carers of children (2-16 years) with cerebral palsy and GORD.
Poole Hospital NHSFT
Poole, Dorset, BH15 2JB, United Kingdom
Poole Hospital
Poole, Dorset, BH15 2JB, United Kingdom
Kleinman L, Nelson S, Kothari-Talwar S, Roberts L, Orenstein SR, Mody RR, Hassall E, Gold B, Revicki DA, Dabbous O. Development and psychometric evaluation of 2 age-stratified versions of the Pediatric GERD Symptom and Quality of Life Questionnaire. J Pediatr Gastroenterol Nutr. 2011 May;52(5):514-22. doi: 10.1097/MPG.0b013e318205970e.
Mark P Tighe, MRCPCH
University Hospitals Dorset NHS Foundation Trust
First Submitted
February 27, 2020
First Posted
March 3, 2020
Study Start
January 22, 2021
Actual (reported)Primary Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Relationship Between Trunk Control and Hand Function and Quality of Life
Contact the study team to confirm eligibility.
Study Completion
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 18, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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