Clinical trial NCT06402253: A Music and Visual Arts Digital Intervention in Teenagers to Promote Healthy Engagement With Social Media.
Official title: Social Media Artistic tRaining in Teenagers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Subjects
Mental Health Issue
Keywords: Mental health
Adolescents
Social media
Music
Neuroarts
Cognition
Brain imaging
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: American Composers Orchestra
First posted: 2024-05-07
Enrollment: 90
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is organized around a 3-month digital music composition intervention for teenagers between 13 and 16 years old. This main music intervention will be compared with an active digital visual-art (i.e., photography) intervention, whose content is planned in parallel with the music one, and a passive no-intervention control group. The interventions will be administered in 24 sessions, with two 1-hour classes per week. Active interventions will cover both basic structural concepts (around music or photography, in each case) that will allow the participants to expand their understanding and appreciation of these kind of artistic stimuli; as well as hands-on experience in specific software for music / photography composition and edition (i.e., Soundtrap, Photoshop). Passive control participants will be monitored for 3-months and offered to complete one of the trainings after completing the study.

All groups will complete evaluations before and after the 3-month interventions.
Primary purpose: BASIC_SCIENCE

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 (i.e., 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-arts/photography), 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 (e.g., phones/tablets) 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 U.S. 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 (i.e., 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, and/or 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 (e.g., 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 groups/arms: one focused on music composition/edition and another on photography composition/edition. 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 (Pre/Post) 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 health/cognitive 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 SoundTrap/GarageBand (Music group) and LightRoom/Photoshop (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 criticisms/feedback. 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 NYU's 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 (1.5x1.5x1.5 mm3; 128 diffusion weighted volumes; b-value of 1500 s/mm2). The investigators will also collect information regarding participant's 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 (e.g., 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 education/culture 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 protocol/study. 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 (i.e., The Conversation, Naukas), are ensured thanks to the ongoing involvement of Dr. Vaquero in these types of activities.

Eligibility criteria: INCLUSION CRITERIA:

* We are not concerned with country of birth, native language, race, or gender. Furthermore, we will not exclude subjects based on their neurodevelopmental, neurological, or psychiatric disorders, or based on their background or previous training in music, visual/plastic arts, or film/multimedia.
* We will recruit participants who are 13-16 years old.
* If they agree to participate in the neuroimaging sessions, participants will not have any contraindications for completing MEG or MRI scans.
* In addition, we intend to recruit the parents of child participants to answer questions about their child. For these participants, we have no inclusion criteria except that they are the parent of a child participating in the study.

EXCLUSION CRITERIA:

* We will exclude participants who are not between the ages of 13 and 16 years old.
* For the additional neuroimaging measures, we will exclude participants who have any contraindications for MEG or MRI if they choose to participate in the optional MEG and MRI scans.
* For recruiting parents, we will exclude those who are not parents of a child enrolled in the study.

Primary outcomes:
measure: Post - Pre changes in attitudes and importance given to social media
timeFrame: From enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in social media profiles followed in social media
timeFrame: From enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in mood and emotional reaction while being online
timeFrame: From enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Weekly evolution of screentime
timeFrame: From week 1 to week 12 of the intervention (or 3-month no intervention period for the control group).
measure: Weekly evolution of mood
timeFrame: From week 1 to week 12 of the intervention (or 3-month no intervention period for the control group).
measure: Post - Pre changes in self-esteem
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in Depression (CDI)
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in Anxiety (SCARED)
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in Mood
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in Attention
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in verbal learning and memory
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in auditory working memory
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in functional connectivity at rest
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in neurophysiological correlates of pre-attentive auditory detection
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in brain morphology / anatomy
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in brain structural connectivity
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
Secondary outcomes:
measure: Treatment Fidelity
timeFrame: From beginning of the intervention to end of intervention (at week 12)
measure: Students' Engagement during Interventions
timeFrame: From beginning of the intervention to end of intervention (at week 12)
measure: Post - Pre changes in self-reported screentime
timeFrame: From enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in social media platforms used
timeFrame: From enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in types of posts shared online
timeFrame: From enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Weekly evolution of apps most used during weekday
timeFrame: From week 1 to week 12 of the intervention (or 3-month no intervention period for the control group).
measure: Weekly evolution of apps most used during weekend day
timeFrame: From week 1 to week 12 of the intervention (or 3-month no intervention period for the control group).
measure: Post - Pre changes in Depression (DASS21)
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in Anxiety (DASS21)
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in Stress (DASS21)
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in the Total Mood Disturbance (POMS)
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in Social Anxiety
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in Focused Attention and Executive Functions
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
measure: Post - Pre changes in functional connectivity at rest within different frequency bands
timeFrame: Difference from enrollment to the end of the post-intervention evaluation (roughly at week 14).
Other outcomes:
measure: Students' Feedback about the Intervention
timeFrame: End of intervention (week 12)
Locations:
city: Brooklyn
country: United States
facility: Fort Hamilton High School
state: New York
city: New York
country: United States
facility: Faculty of Arts & Science, Psychology Department - New York University
state: New York
Study officials:
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