Clinical trial NCT05974917: Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
Official title: Serious gaMe Come Interventi Emergenti di E-health Per i Giovani Con distuRbi neuroLogici o rEspiratori (SMILER) - Progetto@Cnr
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Serious Game
Asthma in Children
Children, Only
Lead sponsor: Istituto di Farmacologia Traslazionale - sede di Palermo, Consiglio Nazionale delle Ricerche (CNR)
Sponsor class: NETWORK
First posted: 2023-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female children aged 12 to 17 years. According to a computer-generated list, thirty children with controlled persistent asthma will be randomised into two groups: Asthma Group 1 and Asthma Group 2 'standard care'.

Brief summary: The main purpose of 'Serious Games' (SG) is to provide opportunities for constructive learning and training. They are well-accepted instruments in therapeutic interventions and have been found to be efficient to improve cognitive areas, social interaction and motor skill function.

The SG is expected to improve asthmatic children's behaviour by providing a positive psychosocial experience with positive effects on asthma outcomes.

Participants will be subjected to SG as part of routine medical care, and researchers will study the effect of SG.

The aim of the study is to evaluate the impact of an innovative SG on neurobehavioural patterns through a randomised controlled pilot study in adolescents with controlled asthma and on the modulation of the expression pattern of CTRA 'Conserved Transcriptional Response to Adversity'.


Eligibility criteria: Inclusion Criteria:

* diagnosis of controlled asthma according to GINA recommendations (http://ginasthma.org)

Exclusion Criteria:

* flare-ups requiring oral corticosteroids within the last four weeks
* use of leukotriene receptor antagonists or therapy as required in the last four weeks
* respiratory infections within the last four weeks
* immunological, metabolic, cardiac or neurological diseases
* obesity
* preterm birth
* major malformations of the respiratory system
* active smoking
* pregnancy

Primary outcomes:
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: 6 months
measure: Skills and Difficulties Questionnaire (SDQ-Ita)
timeFrame: 6 months
Secondary outcomes:
measure: Conserved Transcriptional Response to Adversity (CTRA)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
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citation: Montalbano L, Ferrante G, Montella S, Cilluffo G, Di Marco A, Bozzetto S, Di Palmo E, Licari A, Leonardi L, Caldarelli V, Ghezzi M, La Grutta S, Rusconi F; Italian Pediatric Severe Asthma Network (IPSAN) Program of Italian Paediatric Respiratory Society (IPRS). Relationship between quality of life and behavioural disorders in children with persistent asthma: a Multiple Indicators Multiple Causes (MIMIC) model. Sci Rep. 2020 Apr 24;10(1):6957. doi: 10.1038/s41598-020-62264-9.
citation: Montalbano L, Cilluffo G, Gentile M, Ferrante G, Malizia V, Cibella F, Viegi G, Passalacqua G, La Grutta S. Development of a nomogram to estimate the quality of life in asthmatic children using the Childhood Asthma Control Test. Pediatr Allergy Immunol. 2016 Aug;27(5):514-20. doi: 10.1111/pai.12571. Epub 2016 May 6.
citation: Montella S, Baraldi E, Cazzato S, Aralla R, Berardi M, Brunetti LM, Cardinale F, Cutrera R, de Benedictis FM, di Palmo E, Di Pillo S, Fenu G, La Grutta S, Lombardi E, Piacentini G, Santamaria F, Ullmann N, Rusconi F; Italian Pediatric Severe Asthma Network (IPSAN) on behalf of the Italian Society of Pediatric Respiratory Diseases (SIMRI). Severe asthma features in children: a case-control online survey. Ital J Pediatr. 2016 Jan 22;42:9. doi: 10.1186/s13052-016-0217-z.
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citation: Licari A, Ferrante G, Marseglia Md GL, Corsello Md G, La Grutta S. What Is the Impact of Innovative Electronic Health Interventions in Improving Treatment Adherence in Asthma? The Pediatric Perspective. J Allergy Clin Immunol Pract. 2019 Nov-Dec;7(8):2574-2579. doi: 10.1016/j.jaip.2019.08.008. Epub 2019 Aug 16.