Viewing Study NCT06402253



Ignite Creation Date: 2024-05-11 @ 8:31 AM
Last Modification Date: 2024-10-26 @ 3:28 PM
Study NCT ID: NCT06402253
Status: RECRUITING
Last Update Posted: 2024-05-07
First Post: 2024-04-15

Brief Title: A Music and Visual Arts Digital Intervention in Teenagers to Promote Healthy Engagement With Social Media
Sponsor: New York University
Organization: New York University

Study Overview

Official Title: Social Media Artistic tRaining in Teenagers
Status: RECRUITING
Status Verified Date: 2024-03
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: SMART
Brief Summary: The primary goal of this interventional study is to explore whether 3 months of arts-based digital interventions can change the way in which teenagers 13-16 years of age use social media and are affected by them The main questions it aims to answer are

Can we give teenagers new stimulating and more goal-oriented ways of using social media through arts-based digital trainings and active discussions around social media
Can these arts-based digital interventions also help teenagers to overcome the negative consequences of social media overuse such as depression anxiety and reduced attention and cognitive performance Secondarily this study also aims to explore the brain and behavioral traits associated with these arts-based interventions to better understand how they work

Researchers will compare a music composition intervention with two other interventions an active control intervention based on visual-arts instead of music ie photography and a passive approach to control for the mere pass of time

Participants will

Complete a baseline and a post-intervention evaluation where researchers will obtain measures of cognitive performance attention and executive functions mainly mood mental health brain structure and function and social media usage and attitudes towards these platforms
Complete weekly measures regarding their use of social media platforms and their mood
Complete 3-month arts-based composition edition intervention based on music or visual-artsphotography or the equivalent time with no intervention passive control group

The motivation of this study was driven by the observation that in recent years there has been an increasing use of social media and digital devices in teenagers while the scientific community still does not fully understand the effects of the overuse of these digital means and platforms Moreover some of the negative effects described to be associated with the passive overuse of social media tap on the same brain structures that are benefited by musical and artistic trainings Hence we thought it could be worth trying to use arts-based training to help teenagers compensate for or overcome the negative effects of social media at the neural cognitive mood and mental health levels

This study introduces novelty through three main aspects Firstly it employs a digital art creation approach that requires no classical art training making it more accessible and less intimidating Secondly it incorporates commonly used digital devices eg phonestablets and motivating environments into the learning process integrating the development of new digital skills and the practice of critical thinking around the use of SM into normal classroom activities Finally the study employs a multi-methodological approach to explore the brain mechanisms underlying mental-health and cognitive changes resulting from arts-based interventions

Finally we believe that conclusions from SMART will

set the basis for developing preventive and therapeutic interventions for depression and anxiety in teenagers
promote educational programs that provide optimal tools for adolescents to navigate social media in a healthy manner and
inspire educational policy
Detailed Description: 1 Project Description Smart devices and social media SM have become prevalent among teenagers raising questions about their effects on mental health and cognition Most recent research has focused on the negative effects of SM overuse including an increased risk of developing depression and anxiety and alterations in cognitive functions mainly attention However SM have also proven to have positive influences such as promoting social interaction creativity and wellness among others Hence the issue does not seem to be the time spent on SM per se but the type of activity content and engagement the adolescents carry out on these platforms As the US Surgeon General recently warned with the increasing use of smart devices and SM in youth more resources must be dedicated to assessing which SM activities are beneficial or detrimental for the developing brain of adolescents

On the other hand prior research suggests that art-based interventions such as those based on music improve mental health and promote plastic changes in brain networks related to executive function and emotional regulation Interestingly these same brain areas and functions are known to be affected by SM passive overuse

Thus here the investigators use music and visual arts interventions to transform adolescent usage of SM with the aim of mitigating the negative effects of excessive passive use of these platforms The research team hypothesizes that both music and visual art interventions will improve mental health and enhance cognition Further researchers expect this cognitive and mental-health improvement to be paired with structural changes in brain centers related to emotional processing and executive function
2 Research Question The main motivation and research question behind SMART is whether art appreciation and practice can change the way teenagers interact on SM overcoming the negative influence of smart devices and social media platforms and ultimately leading to beneficial cognitive and emotional effects The first specific goal is to transform the use of social media in teenagers by providing them with digital ie using software solutions arts-based training tools and goal-oriented activities that they can implement in SM while stimulating their critical thinking about these platforms The investigators hypothesize that these tools and reflections will help the participants have a healthier relationship with SM aiding them for instance to be critical about the content shared online to look for healthier and more respectful online interactions andor to look for more stimulating activities to do online

The second specific goal would be to elucidate the behavioral and brain mechanisms behind the potential effects of music and visual-arts interventions on cognitive and emotional processing Researchers expect the digital arts-based interventions to have positive effects on executive functions specifically in the realm of attention and on emotional and mental health markers Investigators hypothesize that improvements in mental health will correlate with plastic changes in emotional and reward-related centers such as ventral striatum and ventromedial prefrontal cortex Furthermore the research team predicts that cognitive improvements will be related to plastic changes in prefrontal regions related to attention and executive functions

As secondary goals SMART aims to develop art-related training programs that are useful motivating and applicable in educational contexts Investigators would also like them to be applicable to preventive and therapeutic approaches aiming to improve the wellbeing and mental health of patients living with chronic conditions such as diabetes cancer or major depression Ultimately the researchers aim to raise awareness of the benefits and importance that art-related activities especially musical ones have during development
3 Research Applications Although some recent and currently ongoing investigations are also working on improving attention and executive functions in children and adolescents through cognitive training even by using music and visual-arts interventions the proposed project is the first of its kind in exploring the effects of arts-based training in transforming adolescents use of SM If predicted benefits from digital artistic interventions are confirmed conclusions from SMART will have a ground-breaking impact in policy making regarding adolescents mental health and education Moreover the conclusions and materials developed within this project have the potential to be applied in clinical contexts eg health education therapeutic purposes in a wide array of physical and mental health conditions For instance arts-based interventions like the ones proposed here could be developed for the management of stress depression and anxiety symptoms associated with chronic health conditions such as diabetes or cancer
4 Methodology High school students 9th graders ages 13-16 will be recruited and divided into two intervention groupsarms one focused on music compositionedition and another on photography compositionedition An additional group that will not complete any intervention will be part of the study as a passive control Participants will be recruited from Fort Hamilton High School a public school in Brooklyn NYC and other public high schools in the NYC area with which collaboration agreements are being set nowadays A pre-post longitudinal experimental design will be implemented A sample size analysis determined that to have 80 of power to detect a large effect in a 2 PrePost x 3 Group Music Visual Art Control mixed between-within repeated measures ANOVA 18 participants per group are required Investigators will recruit 30 participants per group to account for attrition Individual experience in music and visual arts will be taken into account mostly targeting non-experts but not excluding by that factor Interventions will be administered in 1-hour sessions twice a week for 3 months 24 sessions 3-month art-based interventions have been previously optimal at inducing mental healthcognitive improvements and brain plasticity Interventions will include basic structural concepts from each discipline musical visual so that participants are able to appreciate edit and create from scratch their own digital pieces while maintaining a parallel structure and exigency between both types of interventions

Participants will create their artistic pieces using software such as SoundTrapGarageBand Music group and LightRoomPhotoshop Visual Art group The classes will also include concepts related to the creative process exploration of curiosity and identity within artistic activities teamwork and collaboration SM will be used or included in discussions with the students every week to explore inspiration reflect on what artists share online be critical about how people comment online and how to react to criticismsfeedback The control group will not receive any musical or visual art training initially but will be able to complete the intervention of their choice once the study is over The interventions will be taught by experienced instructors from the American Composers Orchestra Music and NYUs department of Integrated Design and Media Visual Art

All participants will complete a baseline and a post-intervention 3-month follow-up evaluation that will include i measures of mental health via validated self-reports of depression anxiety general mood and self-esteem ii cognitive function attention measured via a flanker and a foraging inattentional blindness task and iii brain plasticity via the assessment of gray GM and white matter WM structure MRI Regarding the latter researchers will collect high resolution T1-weighted images 1x1x1 mm3 for GM analysis and a diffusion-weighted MRI sequence for WM 15x15x15 mm3 128 diffusion weighted volumes b-value of 1500 smm2 The investigators will also collect information regarding participants attitudes opinions and usage of SM and their sensitivity to general and artistic rewards Continuous measures will include weekly input regarding i progression of abilities and engagement in the arts classes by instructors and main research intervention groups ii mood and motivation states PANAS and iii self-reported SM usage by filling the number of hours spent on their smartphones and the list and hours spent on their most-used apps via their smartphone built-in screen-time function

Longitudinal changes in mental health and cognition will be assessed using JASP and a mixed within-between repeated measures 3x2 ANOVA Post-hoc tests with Tukey correction for multiple comparisons will be used for significant main effects and interactions Brain changes will be assessed via Voxel Based Morphometry as implemented in SPM12 and CAT12 FWE-correction will be used to control for multiple comparisons For WM researchers will use Tract-Based Spatial Statistics TBSS and will perform tractography of the main white matter pathways eg arcuate inferior longitudinal uncinate and inferior fronto-occipital fasciculi corpus callosum etc using Automatic Fiber Quantification The investigators will assess markers of microstructural WM integrity previously related to cognitive and mental health status Fractional Anisotropy Axial Radial and Mean Diffusivity FWE-correction using non-parametric permutations will be used to control for multiple comparisons Spearman correlations will be used to assess the relationship between significant changes in mental health cognitive and brain plasticity

Regarding recruitment timelines the researchers expect to have active groups recruited completing the interventions during both the Fall 2024 and the Spring 2025 semesters and take the Fall 2025 semester to work on finding matching controls and adjusting recruitment to compensate for the expected attrition rate of 20-30 of recruited participants
5 Access and Dissemination Dissemination actions will target both the scientific community and the general public All publications will be released as open access articles in international peer-reviewed scientific journals All data and teaching materials from both interventions will be released as open-access resources Also to raise awareness about the issues that could be improved by exploiting SMART results white papers directed to educationculture policy makers will also be published Oral and poster presentations at renowned international conferences such as Human Brain Mapping and Society for Neuroscience are also planned Actually this protocol has been accepted to be presented as a poster at the Music and Neuroscience VIII conference that will be held in Helsinki in June 2024 this is the most important event for the neuroscience of music research held every 3 years

Also SMART 1-day workshops at local schools will be held targeting parents teachers and educators as well as policy makers These workshops will explain the rationale and the project characteristics and results obtained up to that moment and will be used to hold open discussions with attendants to solve doubts and fully understand stakeholders interests and concerns These discussions could also motivate future work and an expansion of the current intervention protocolstudy The research team is currently working on the setup of the SMART website and Social Media accounts aiming to inform and keep up to date both the scientific community and the general population regarding the development of the project Finally participation on national and international science outreach activities such as science fairs and conferences at public and private schools and science popularization articles published in online dedicated platforms ie The Conversation Naukas are ensured thanks to the ongoing involvement of Dr Vaquero in these types of activities

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
Secondary IDs
Secondary ID Type Domain Link
2023 OTHER_GRANT GRAMMY Museum Foundation None
101063319 OTHER_GRANT None None