Viewing Study NCT04247516



Ignite Creation Date: 2024-05-06 @ 2:12 PM
Last Modification Date: 2024-10-26 @ 1:27 PM
Study NCT ID: NCT04247516
Status: COMPLETED
Last Update Posted: 2022-01-04
First Post: 2020-01-22

Brief Title: A Study Protocol for an Online Intervention to Promote School Engagement
Sponsor: University of Minho
Organization: University of Minho

Study Overview

Official Title: A Study Protocol for an Online Intervention to Promote School Engagement Through Gamification in Children With Cerebral Palsy
Status: COMPLETED
Status Verified Date: 2022-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Cerebral Palsy CP is a neurological non-progressive and permanent developmental disorder that mainly affects movement and posture with a prevalence of 3 to 4 children per 1000 live births CPs motor impairments are often accompanied by disturbances of sensation perception cognition communication and behavior These impairments echo in the activities of daily life as well as in the learning process Importantly children with CP are especially prone to display working memory and EFs deficits as well as difficulties in self-regulation which might help explain some of their social and learning problems

These children have a high risk of showing learning disabilities which may arise before the schooling years This risk is not exclusively determined by cognitive impairment with children with a normative cognitive level still presenting specific learning difficulties eg mathematics reading

Due to their clinical picture children with disabilities including CP struggle with their difficulties in school Consequently they are prone to develop a poor School Engagement SE - multidimensional and multifaceted construct involving three interrelated dimensions students behaviors emotions and cognition

In children with disabilities one of the factors that contributes to lower SE is their high level of school absenteeism These children miss on average 3 weeks of school in a school year due to health issues which may hinder their academic performance The promotion of SE in children with disabilities is therefore a priority

To promote SE Gamification strategies can be used Gamification is the use of game elements eg points rewards feedback in non-game contexts The potential of using Gamification is high and constitutes a unique opportunity to engage participants in specific activities such as in intervention or learning contexts

Therefore through game mechanics Gamification can be used as a tool to promote SE This is because it offers an attractive learning environment and converts difficult tasks into more appealing ones motivating individuals to perform Moreover it enhances the degree and depth of participant engagement rises behavior and lifestyle changes promotes learning opportunities motivates students and improves intervention appeal especially for youngsters To conclude this project aims to increase SE through Gamification in children with CP

Literature has highlighted the need to focus interventions on SE and self-regulated learning SRL on a specific domain Because children with CP are at high risk of presenting learning difficulties especially in mathematics this project will focus on mathematics performance Moreover SE is multidimensional including behaviors emotions and cognitions related to school Specifically behavioral SE can be conceptualized in three levels 1 school attendance and fulfillment of school work 2 participation in class and 3 active participation eg doing extra school-work Emotional SE refers to students affective reactions and sense of connectedness with school Finally cognitive SE is related to personal investment in academic tasks self-regulation and value of the learning process Because SRL may be compromised in children with CP mainly due to difficulties in planning and setting goals this project will promote SE in mathematics by developing SRL strategies in these children SRL processes are key for students to attain their self-set goals and include competences of planning execution evaluation and monitoring of the learning process SE and SRL will be promoted through Gamification strategies on the Canvas platform

Thus the main purpose is to assess an intervention program with children with CP to increase SE and enhance SRL through Gamification Strategies in mathematics Specifics aims

Embed Gamification Strategies eg rewards collaboration competition in the Canvas Platform using the tools already available eg forumchat
Develop and assess the efficacy and impact of the intervention in promoting SE and SRL competences through an integrated assessment approach functional educational neurocognitive and neuroimaging
Detailed Description: Participants

30 children with CP age-range between 8 and 15 years elementary and middle school - 3rd grade to 9th grade without cognitive impairments will be selected Agreements in partaking in the study are already in place with CP rehabilitation centers on the north of Portugal Participants have already been evaluated through cognitive and neuropsychological tools Specifically children should present a cognitive performance at least in Medium- Low level WISC-III and should have eventual epilepsy episodes under control Participants need to be able to use a computer and have internet access and are required to have a native level of writing and reading skills in the Portuguese language

Recruitment and selection

Recruitment will take place in the Portuguese associations of cerebral palsy A collaboration agreement was established with the Federation of Portuguese Cerebral Palsy Associations FPCPA which includes 15 Cerebral Palsy Associations in Portugal The Associations will evaluate their children and identify those who fulfil the inclusion criteria The first contact with the parentscaregivers will be made by the associations and only after they accept to participate will the research team contact them When identified children and their parents will be debriefed the consents delivered explained and signed

Procedure

The FCPA Federation Associations of Cerebral Palsy will identified the needs to promote self-regulation skills and school involvement of children with CP Researchers will established contact and held formal meetings with therapists to identify key difficulties and needs

a Two questions guided the meetings

i What are the main difficulties you have while intervening with children with CP ii What do you think we could help with For study 4 a randomized controlled trial will be developed with three groups After obtaining informed consent from parentscaregivers participants meeting criteria will be randomly assigned to one condition The control group CG will not have access to the online platform ie no intervention The intervention group 1 IG1 will receive on a weekly basis tasks and activities on the online platform to promote SR and SE as well as chapters of the narrative The intervention group 2 IG2 will receive the same tasks and materials as IG1 but embedded with Gamification Strategies

Phase 1 - Selection of Gamification Strategies

Reeves and Read 2009 identify the Ten Ingredients of Great Games as good examples of elements of Gamification i self-representation with avatars ii three-dimensional environments iii narrative context iv feedback v reputations ranks and levels vi marketplaces and economies vii competition under rules that are explicit and enforced viii teams ix parallel communication systems that can be easily configured x time pressure Specifically in the school context a number of game elements have been identified as promoters of SE contributing to learning success of students collaboration and competition feedback and reputations ranks and levels and reinforcement Accordingly through Canvas Platform tools these elements will be applied to the IG2 The project will be presented to FCPA who will be involved in all stages

Phase 2 - Implementation

The project will be presented at the rehabilitation centers to technicians and parentscaregivers and to children who accept to participate The intervention will take place at the rehabilitation centers and the collaboration of all stakeholders is imperative Parentscaregivers will be asked to stimulate their child to engage with and talk about the intervention and to contact the research team whenever is necessary Secondly parentscaregivers and children will fill-in the informed consents and the socio-demographic questionnaires Each child will have a login through e-mail into the platform

This intervention will take place during the weekly occupational therapy OT sessions at the rehabilitation centers to guarantee implementation of the research protocol eg internet access

Phase 3 - Program evaluation

To capture the procedural dimension of the phenomenon and evaluate the impact of the intervention on the promotion of SE SRL and EF in children with CP several elements will be considered aptitude ie questionnaires event ie checklist observations and neuroplasticity as suggested by the literature of SRL processes Núñez Rosário Vallejo González-Pienda 2013 Zimmerman 2008 The hypothesis is that the intervention will promote statistically significant improvements in the IG1 and IG2 in all measures - SE SRL EF evaluation compared to the CG

The evaluation protocol described refers to assessment that will be conducted with the children participating in the study Children were assessed on their intellectual ability using the Wechsler Intelligence Scale for Children - Third Edition WISC-III Wechsler 2003 Medical and therapists records were reviewed to collect information about the topographic motor type and quality of tonus as well as the childs level on the Gross Motor Function Classification System GMFCS Andrada 2012 Palisano et al 2015 Other variables were gathered gender date of birth school grades from the last year types of therapies each child is attending extracurricular activities internet access at home computer access story reading frequency curricular adaptations

The following measures will be collected before the start of the intervention at the end and 3 months after the intervention completion

1 Neuropsychological assessment

1 This investigation follows the Miyake model of EF This model postulates that EF is comprised of three latent variables with different roles Inhibition Shifting and Updating that can be learned through the individuals performance Miyake Emerson Palisano et al 2015 The CANTAB application was selected for the pre- post assessment From the set of the CANTAB 6 tests were selected i Multitasking Test MTT - To manage conflicting information provided by the direction of an arrow and its location on the screen and to ignore task- irrelevant information Shifting

ii One Touch Stockings of Cambridge OTS - To assess both the spatial planning and the working memory subdomains UpdatingPlanning Based upon the Tower of Hanoi test

iii Stop Signal Task SST - To measure response inhibition and impulse control Inhibition Control

iv Spatial Working Memory SWM - To provide a measure of strategy and of working memory errors

v Motor Screening Task MOT - To provide a general assessment of whether sensorimotor deficits or lack of comprehension will limit the collection of valid data from the participant

vi Emotion Recognition Task ERT - This task measures the ability to identify six basic emotions in facial expressions along a continuum of expression magnitude

b Functional magnetic resonance imaging FMRI

i A classic test of inhibitory control Go-No-go task will be used another test will be adapted using images from the e-book of the Incredible Adventures of the Anastácio the Explorer 2 Self-Report Questionnaires

3 Effort Measures 4 Interviews

a Self-Regulation Learning Rosário et al 2011

i SRL Strategies Inventory

1 Comprises nine self-regulated learning strategies presented in a Likert-like format of 5 points 1never to 5always
2 Items assess the three phases of SRL model PLEE three items per each phase i Planning eg I make a plan before I begin writing I think about what I want to say and how I need to write it - α80 ii Execution eg If I become distracted or lose concentration while I am in class or studying then I usually try to regain my goals - α85 iii Evaluation eg I compare the grades I receive with the goals I set for that subject- α87

b Engagement

ii School Engagement Scale Fredricks et al 2005

1 The scale comprises 14 items presented in a Likert-like format of 5 points 1never to 5always
2 Items cluster in the three SE dimensions ie behavioral emotional and cognitive

i Behavioral Engagement scale comprises 5 items eg I follow the rules at school α77

ii Emotional Engagement scale comprises 6 items eg I feel happy in school α86 iii Cognitive Engagement scale comprises 8 items eg I study at home even when I dont have a test α82
1 Throughout the interventions children will be asked to complete different tasks on a voluntary basis eg viewing videos participation in the discussion forums
2 The fulfillment of these tasks and of the sessions goals will be on-task measures of childrens involvement with the intervention program

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1 Children therapists and parentscaregivers will be selected for a purposeful sample upon completion of the program
2 Interviews will be semi-structured to further understand the effectiveness of the intervention

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None