Clinical trial NCT06407908: Urdu Translation Of Pediatric Version Of Eating Assessment Tool
Official title: Urdu Translation and Psychoprometric Properties Of Pediatric Version Of Eating Assessment Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: validation
translation
eating disorder
PEDI-EAT-10
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 42
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample size is 42.

Brief summary: Dysphagia encompasses challenges encountered during the many stages of swallowing, including the oral phase, commencement of the swallow, pharyngeal phase, and esophageal phase. The incidence of pediatric dysphagia is on the rise as a result of advancements in medical care that have led to higher survival rates among infants born prematurely, with low birth weight, and with complex medical disorders. The Eating Assessment Tool (EAT-10), consisting of 10 items, was first developed for infant patients.

(PEDI-EAT-10) will be translated into Urdu language by using forward backwards translation method. Two bilingual speakers expert in both Urdu and English languages will assist the researcher in the forward translation of the tool. This final translated version will be then tested for validity and reliability on all participants of the study. The psychometric properties of the tool will be assessed including reliability, internal consistency, and item discrimination.

Detailed description: A mix method approach will be applied

1. Forward translation
2. Reconciliation of items
3. Backward translation
4. Review of forward and backward translation
5. Pre-testing (cognitive interviewing)
6. Validation study The process of translation followed the guidelines in the translation manual. Translators translate the pediatric version of eating assessment tool (Pedi-EAT-10), independently from each other into the Urdu language considering the following guidelines: using natural language acceptable to the broader public, performing a clear, simple, and understandable translation, avoiding lengthy and complicated sentences. This will be followed by a backward translation to ensure that the content, from the conceptual point of view, had not been modified in the translation. A native English translator was requested to carry out the back-translation, and all discrepancies were identified and corrected. To show whether all items are easily understood and acceptable to the patients, pretesting the final translated questionnaire will be conducted by administering it to patients with a varying education level. The questions that were not easily understood were discussed and redrafted by a panel of researchers until all interviewees understood all items.

Eligibility criteria: Inclusion Criteria:

* Parents of children diagnosed with eating disorders
* Age from 3 to 15 years

Exclusion Criteria:

* Parents with children Unable to understand the questionnaire
* Parents with children who have Intellectual disability and any organic type of incontinence, neurological or anatomical problems
* Parents with who have children Severe cognitive decline or dementia
* Parents with children cannot understand Urdu.

Primary outcomes:
measure: Pediatric Version of the Eating Assessment Tool (Pedi-EAT-10)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Fatima Ahsan, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varni JW, Limbers CA, Neighbors K, Schulz K, Lieu JE, Heffer RW, Tuzinkiewicz K, Mangione-Smith R, Zimmerman JJ, Alonso EM. The PedsQL Infant Scales: feasibility, internal consistency reliability, and validity in healthy and ill infants. Qual Life Res. 2011 Feb;20(1):45-55. doi: 10.1007/s11136-010-9730-5. Epub 2010 Aug 22.