AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood (AQUAPed)

The AQUA© questionnaire developed in 2008 is a validated tools for the screening of allergic diseases in adult athletes. The objective of the present study is to develop and validate a modified version of the AQUA© questionnaire to be used in childhood. In this phase, the validation is intended to assess the reliability of the information collected through the AQUA© modified version: question difficulty and response patterns with respect to children characteristics (in particular age, sex and physical activity). In particular, the focus will be on the "core questions", i.e. the indicators of allergic disorders. This is a cross-sectional study on 1264 healthy schoolchildren aged 8 to 14 years.

Study Overview

• Status: Completed
• Conditions: Healthy

• Study Type: Observational
• Enrollment (Actual): 1264

Contacts and Locations

Study Locations

• Italy
  • Sicily
    • Palermo, Sicily, Italy, 90146
      • Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 1264 healthy schoolchildren, both males and females, aged 8 to 14 years, recruited in 7 primary and secondary schools of the city of Palermo.

Description

Inclusion Criteria:

• Aforementioned sex and age criteria.

Exclusion Criteria:

• Respiratory infections in the previous 3 weeks;
• Immunological or metabolic systemic disease;
• Major malformations of the upper airways;
• Active smoker.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1264 healthy schoolchildren; There is only one study group consisting of 1264 children recruited at school.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Question difficulty	Comprehensibility (or difficulty) of the questions, especially the "core questions", will be assessed by the percentages of non-response possibly stratified by children characteristics (in particular age, sex and physical activity).	Study end (4 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patterns of missing response	Possible tendency to skip consecutive questions will be assessed by studying the association between the presence of missing (0 = answer missing, 1 = answer given) in sequence (tetrachoric correlation).	Study end (4 months)
Patterns of non-missing responses	Analysis of the distribution of non-missing responses, possibly stratified by children characteristics (in particular age, sex and physical activity).	Study end (4 months)

Collaborators and Investigators

• Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 7/2017_D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No