Mealtime Assessment Scale-p Adaptation and Validation

NCT06094595 | Unknown

• 1 other identifier: MAS-p
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to adapt the Mealtime Assessment Scale (MAS) in a pediatric population in order to provide an observational tool compiled by swallowing professionals, in Italian, for the assessment of swallowing efficacy and safety during mealtime in an ecological setting, as mealtime administration occurs independently or by the caregiver.

Conditions

Dysphagia

Keywords

Pediatric population; Dysphagia assessment

Outcome Measures

Primary Outcomes (5)

• Mealtime Assessment Scale - pediatric (MAS-p) adaptation

  Drafting of the MAS-p scale as an adaptation of the MAS scale to the pediatric population 0 best value - 26 worst value

  February - March 2022

• Meal Assessment Scale-pediatric (MAS-p) validation: internal consistency

  Internal consistency is evaluated using Cronbach's alpha. In addition, Cronbach's alpha without an item was computed to identify whether the exclusion of the item would improve internal consistency. A good internal consistency is assumed in the presence of Cronbach's alpha \> 0.70

  March - August 2022

• Meal Assessment Scale-pediatric (MAS-p) validation: intra-rater agreement

  The intra-rater agreement was evaluated by Intraclass Correlation Coefficient (ICC). An ICC above 0.75 was considered as indicating good agreement

  March - August 2022

• Meal Assessment Scale-pediatric (MAS-p) validation: inter-rater agreement

  Inter-rater agreement was tested using the average deviation index (AD index). A good inter-rater agreement was considered for an AD index below 0.66

  March - August 2022

• Meal Assessment Scale-pediatric (MAS-p) validation: discriminative ability

  The discrimination index was used to measure each item's ability to discriminate between those who scored high on the scale and those who scored low. The index was calculated for each item of the subscales Swallowing safety during the meal and Swallowing efficacy during the meal. The discrimination index was calculated as the difference between the number of individuals with a total score above the median who scored positive (2 or 3) on the item and the number of individuals with a total score below the median who scored positive on the item divided by the number of individuals above the median. Values above 0.4 were considered high, and above 0.2 desirable

  March - August 2022

Interventions

MAS-p administration DIAGNOSTIC_TEST

Each patient will be assessed the first time at mealtime by two experienced speech therapists, and scores obtained on the MAS-p will be recorded independently and blinded to each other. The two scales selected for comparison will also be administered at the same time. The assessment with the MAS-p scale will be repeated 48 hours apart, a time considered optimal in order to avoid possible bias related to the clinical improvement of the patient undergoing rehabilitation treatment, by one of the two speech therapists.

Eligibility Criteria

• Age: 24 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This observational study examines subjects at risk for swallowing disorders. Subjects will be enrolled after clinical and speech evaluation in inpatient and outpatient settings. Competitive recruitment is planned among the involved centers IRCCS Fondazione Don Gnocchi ONLUS of Florence, Azienda Ospedaliero-Universitaria Meyer of Florence, Centro Bignamini Fondazione Don Gnocchi ONLUS of Falconara Marittima (AN), until the total of 240 subjects is reached. The signing of an informed consent to participate in the study by the subject's parent or legal guardian and compliance with the following inclusion and exclusion criteria is required.

You may qualify if:

• Age between 24 months and 18 years
• Presence of risk factors for swallowing disorders of different etiology and severity at clinical evaluation
• Tolerance to exclusive oral feeding of a full or partial meal

You may not qualify if:

• Exclusive use of alternative feeding methods: nasogastric tube, percutaneous endoscopic gastrostomy (PEG), percutaneous endoscopic gastro-jejunal (PEG J)
• Absent or non-compliant caregiver

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Fondazione Don Carlo Gnocchi ONLUS - Centro Bignamini, Falconara Marittima: collaborator
• Meyer Children's Hospital IRCCS: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi Onlus

Florence, 50018, Italy

RECRUITING

Related Publications (18)

• Lawlor CM, Choi S. Diagnosis and Management of Pediatric Dysphagia: A Review. JAMA Otolaryngol Head Neck Surg. 2020 Feb 1;146(2):183-191. doi: 10.1001/jamaoto.2019.3622.

  PMID: 31774493 BACKGROUND

• Bhattacharyya N. The prevalence of pediatric voice and swallowing problems in the United States. Laryngoscope. 2015 Mar;125(3):746-50. doi: 10.1002/lary.24931. Epub 2014 Sep 15.

  PMID: 25220824 BACKGROUND

• Quitadamo P, Thapar N, Staiano A, Borrelli O. Gastrointestinal and nutritional problems in neurologically impaired children. Eur J Paediatr Neurol. 2016 Nov;20(6):810-815. doi: 10.1016/j.ejpn.2016.05.019. Epub 2016 Jun 11.

  PMID: 27397730 BACKGROUND

• Arvedson JC. Assessment of pediatric dysphagia and feeding disorders: clinical and instrumental approaches. Dev Disabil Res Rev. 2008;14(2):118-27. doi: 10.1002/ddrr.17.

  PMID: 18646015 BACKGROUND

• Rogers B, Arvedson J. Assessment of infant oral sensorimotor and swallowing function. Ment Retard Dev Disabil Res Rev. 2005;11(1):74-82. doi: 10.1002/mrdd.20055.

  PMID: 15856438 BACKGROUND

• Majnemer A, Snider L. A comparison of developmental assessments of the newborn and young infant. Ment Retard Dev Disabil Res Rev. 2005;11(1):68-73. doi: 10.1002/mrdd.20052.

  PMID: 15856441 BACKGROUND

• Barton C, Bickell M, Fucile S. Pediatric Oral Motor Feeding Assessments: A Systematic Review. Phys Occup Ther Pediatr. 2018 May;38(2):190-209. doi: 10.1080/01942638.2017.1290734. Epub 2017 Apr 21.

  PMID: 28430014 BACKGROUND

• Ramsay M, Martel C, Porporino M, Zygmuntowicz C. The Montreal Children's Hospital Feeding Scale: A brief bilingual screening tool for identifying feeding problems. Paediatr Child Health. 2011 Mar;16(3):147-e17. doi: 10.1093/pch/16.3.147.

  PMID: 22379377 BACKGROUND

• Ortega Ade O, Ciamponi AL, Mendes FM, Santos MT. Assessment scale of the oral motor performance of children and adolescents with neurological damages. J Oral Rehabil. 2009 Sep;36(9):653-9. doi: 10.1111/j.1365-2842.2009.01979.x. Epub 2009 Jul 15.

  PMID: 19627455 BACKGROUND

• Sanchez K, Spittle AJ, Allinson L, Morgan A. Parent questionnaires measuring feeding disorders in preschool children: a systematic review. Dev Med Child Neurol. 2015 Sep;57(9):798-807. doi: 10.1111/dmcn.12748. Epub 2015 Mar 24.

  PMID: 25809003 BACKGROUND

• Myer CM 4th, Howell RJ, Cohen AP, Willging JP, Ishman SL. A Systematic Review of Patient- or Proxy-Reported Validated Instruments Assessing Pediatric Dysphagia. Otolaryngol Head Neck Surg. 2016 May;154(5):817-23. doi: 10.1177/0194599816630531. Epub 2016 Apr 5.

  PMID: 27048665 BACKGROUND

• Reilly S, Skuse D, Mathisen B, Wolke D. The objective rating of oral-motor functions during feeding. Dysphagia. 1995 Summer;10(3):177-91. doi: 10.1007/BF00260975.

  PMID: 7614860 BACKGROUND

• Pizzorni N, Valentini D, Gilardone M, Borghi E, Corbo M, Schindler A. The Mealtime Assessment Scale (MAS): Part 1 - Development of a Scale for Meal Assessment. Folia Phoniatr Logop. 2020;72(3):169-181. doi: 10.1159/000494135. Epub 2019 Apr 18.

  PMID: 30999311 BACKGROUND

• Pizzorni N, Valentini D, Gilardone M, Scarponi L, Tresoldi M, Barozzi S, Corbo M, Schindler A. The Mealtime Assessment Scale (MAS): Part 2 - Preliminary Psychometric Analysis. Folia Phoniatr Logop. 2020;72(3):182-193. doi: 10.1159/000494136. Epub 2019 Apr 17.

  PMID: 30995652 BACKGROUND

• Hansen T, Lambert HC, Faber J. Reliability of the Danish version of the McGill Ingestive Skills Assessment for observation-based measures during meals. Scand J Occup Ther. 2012 Nov;19(6):488-96. doi: 10.3109/11038128.2012.674552. Epub 2012 May 1.

  PMID: 22545775 BACKGROUND

• Ortega Ade O, Marques-Dias MJ, Santos MT, Castro T, Gallottini M. Oral motor assessment in individuals with Moebius syndrome. J Oral Pathol Med. 2014 Feb;43(2):157-61. doi: 10.1111/jop.12107. Epub 2013 Aug 10.

  PMID: 23930941 BACKGROUND

• Kaviyani Baghbadorani M, Soleymani Z, Dadgar H, Salehi M. The effect of oral sensorimotor stimulations on feeding performance in children with spastic cerebral palsy. Acta Med Iran. 2014;52(12):899-904.

  PMID: 25530052 BACKGROUND

• Arvedson JC, Lefton-Greif MA. Instrumental Assessment of Pediatric Dysphagia. Semin Speech Lang. 2017 Apr;38(2):135-146. doi: 10.1055/s-0037-1599111. Epub 2017 Mar 21.

  PMID: 28324903 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Giovanna Cristella, MD

  IRCCS Fondazione Don Carlo Gnocchi ONLUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanna Cristella, MD

CONTACT

0557393949; gcristella@dongnocchi.it

Laura Antonucci, MD

CONTACT

0557393947; lantonucci@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: October 23, 2023
• Study Start: March 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: November 30, 2024
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

IT (1)