Dataset Information

Serious game to promote socioemotional learning and mental health (emoTIC): a study protocol for randomised controlled trial.

ABSTRACT:

Introduction

The development of emotional competences may be a protective factor for mental health problems, promoting well-being at such a complex age as adolescence. Technologies may be used to carry out this empowerment because adolescents are attracted to them. The purpose of the study is to design a serious game based on the Mayer et al's emotional intelligence ability model and analyse the effectiveness of the emoTIC programme to develop emotional competences, well-being, mental health, and personal strengths immediately after completion and at 12 months.

Methods and analysis

The new version of emoTIC will be designed following the suggestions of the adolescents who participated in the pilot study and the results obtained from the statistical analysis. The participants will be 385 adolescents aged 11-16 years who will be randomly assigned to the control group and the experimental group. The experimental group will complete the emoTIC programme. The primary outcomes include emotional competences and subjective well-being. The secondary outcomes are self-esteem; general self-efficacy; personality; social and personal responsibility; school social climate; somatic complaints; depression, anxiety and stress symptoms; emotional and behavioural difficulties; suicidal behaviour; and subjective happiness. Data will be collected at three moments: baseline (T1), immediately post-intervention (T2) and 12-month follow-up (T3). The effectiveness of the programme will be analysed using different statistical packages.

Ethics and dissemination

The study has been approved by the Ethics Commission of the University of Valencia (H152865096049), and the standards of the Declaration of Helsinki to collect the data will be followed. Results will be disseminated across the scientific community.

Trial registration number

ClinicalTrials.gov Registry (NCT04414449).

Trial sponsor

University of Valencia. Principal investigator: Inmaculada Montoya-Castilla.

SUBMITTER: De la Barrera U

PROVIDER: S-EPMC8720981 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionDistal radius fractures are among the most prevalent traumatic injuries worldwide. These injuries are associated with high healthcare-related and socioeconomic costs, mainly resulting from loss of productivity. To optimise recovery and return to work, wrist exercises are recommended. However, adherence to standard exercise regimens is low. Serious games provide a treatment platform for standardised postoperative care, uniting meaningful recovery with entertainment. Also, mobile serious games, for example, smartphone or tablet applications, are able to send practice reminders believed to improve self-efficacy.Methods and analysisTo test the effectiveness of a mobile serious game for distal radius fracture rehabilitation compared with standard care, a multicentre, randomised controlled clinical trial was designed. Primary outcome will be the Patient-Rated Wrist Evaluation (PRWE) score after 6 weeks of treatment. Secondary outcomes are range of motion, grip strength, pain scores, and self-reported treatment adherence after 2, 6 and 12 weeks of treatment.Adult patients with any type of closed distal radius fracture are included directly after non-operative or operative fracture treatment. Patients are recruited in the outpatient clinics of four teaching hospitals. The intended sample size is 92 patients, based on the minimal clinically important difference of the PRWE score at 6 weeks, using a superiority model.Patients are randomised between using the wearable-controlled mobile serious game ReValidate! (intervention group) and standard care consisting of unsupervised exercises and a referral for physiotherapy or exercise therapy upon request or recommendation by the treating clinician (control group).Ethics and disseminationThe protocol has been approved by the Medical Ethical Review Board of the Amsterdam University Medical Centres, location Academic Medical Centre in Amsterdam, the Netherlands. Results will be made available to involved healthcare providers, funders, and to the general public including patients via peer-reviewed academic journals and international conferences.Trial registration numberDutch Trial Registry (NTR), NL6140, protocol V.2.

Project description:IntroductionAutism spectrum disorder (ASD) is characterised by impairments in social communication. Core symptoms are deficits in social looking behaviours, including limited visual attention to faces and sensitivity to eye gaze cues. We designed an intervention game using serious game mechanics for adolescents with ASD. It is designed to train individuals with ASD to discover that the eyes, and shifts in gaze specifically, provide information about the external world. We predict that the game will increase understanding of gaze cues and attention to faces.Methods and analysisThe Social Games for Adolescents with Autism (SAGA) trial is a preliminary, randomised controlled trial comparing the intervention game with a waitlist control condition. 34 adolescents (10-18 years) with ASD with a Full-Scale IQ between 70 and 130 and a minimum second grade reading level, and their parents, will be randomly assigned (equally to intervention or the control condition) following baseline assessments. Intervention participants will be instructed to play the computer game at home on a computer for ~30?min, three times a week. All families are tested in the lab at baseline and approximately 2 months following randomisation in all measures. Primary outcomes are assessed with eye tracking to measure sensitivity to eye gaze cues and social visual attention to faces; secondary outcomes are assessed with questionnaires to measure social skills and autism-like behaviours. The analyses will focus on evaluating the feasibility, safety and preliminary effectiveness of the intervention.Ethics and disseminationSAGA is approved by the Institutional Review Board at Pennsylvania State University (00005097). Findings will be disseminated via scientific conferences and peer-reviewed journals and to participants via newsletter. The intervention game will be available to families in the control condition after the full data are collected and if analyses indicate that it is effective.Trial registration numberNCT02968225.

Project description:BackgroundDepression is the most prevalent mental disorder, with detrimental effects on the patient's well-being, high disability, and a huge associated societal and economic cost. There are evidence-based treatments, but it is difficult to reach all people in need. Internet-based interventions, and more recently smartphone-based interventions, were explored to overcome barriers to access. Evidence shows them to be effective alternatives to traditional treatments. This paper presents the protocol of a pilot study whose primary aim is to investigate the efficacy of a smartphone-based serious game intervention for patients with mild to moderate depressive symptoms.MethodsThis randomized controlled pilot trial protocol foresees two arms design: 1/ smartphone- based serious game intervention (based on Cognitive Behavior Therapy with particular emphasis on Behavioral Activation and Physical Activity), 2/ waiting list control group. The study is expected to recruit 40 participants (18+), which will be randomly assigned to one of the experimental conditions. The duration of the intervention is two months. The primary outcome measure will be depressive symptomatology. Secondary outcomes will include other variables such as physical activity, resilience, anxiety, depression impairment, and positive and negative affect. Treatment expectation, satisfaction, usability, and game playability will also be measured. The data will be analyzed based on the intention-to-treat and per protocol analyses.DiscussionThe study aims to establish initial evidence for the efficacy of a smartphone-based serious game intervention, to serve as input for a larger-scale randomized control trial. The intervention exploits advanced smartphone capabilities, such as the use of a serious game as delivery mode, with the potential benefit of engagement and treatment adherence, and motion sensors to monitor and stimulate physical activity. As a secondary objective, the study aims to gather initial evidence on the user's expectations, satisfaction, usability and playability of the serious game as a treatment.

Project description:BACKGROUND:The prevalence of elevated depressive symptoms among youth in most western societies is high. Yet, most adolescents who are experiencing depressive symptoms do not seek help. Low mental health literacy, high stigma, and low social support have been shown to hinder help-seeking. A small number of interventions has been developed to target mental health literacy and stigma, but few focus on actual help-seeking and first aid behavior. We have developed a game-based school program called Moving Stories that targets mental health literacy, including knowledge and behavior, and stigma among adolescents, in regard to depression specifically. OBJECTIVE:Our aim is to describe the protocol for a study that will test the effectiveness of the program Moving Stories in a Dutch adolescent sample. We hypothesize that adolescents who participate in the program Moving Stories will have better mental health literacy and less stigma regarding depression compared to adolescents in the nonintervention control group at posttest and at 3- and 6-months follow-up. We also expect a positive change in actual help-seeking and first aid behavior at 3- and 6-months follow-up. METHODS:Moving Stories has been developed by a professional game design company in collaboration with researchers and relevant stakeholders. The effectiveness of Moving Stories will be tested through a randomized controlled trial with two conditions: Moving Stories versus control. Participants will fill in questionnaires at pretest, posttest, and 3- and 6-months follow-up. Our power analysis showed a required sample size of 180 adolescents. RESULTS:Four high schools have agreed to participate with a total of 10 classes. A total of 185 adolescents filled in the pretest questionnaire. The last of the follow-up data was collected in December 2018. CONCLUSIONS:If Moving Stories proves to be effective, it could be implemented as a school-based program to target mental health literacy and stigma regarding depression; this could, in turn, improve early help-seeking in adolescents suffering from depression. TRIAL REGISTRATION:Nederlands Trial Register NTR7033; https://www.trialregister.nl/trial/6855. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11255.