Body Image, Identity Development, and Social Media Use Among Youth With Visual Impairment: A Single Case Intervention Study

• Background and Rationale VI is a term used to describe a partial or complete loss of vision that cannot be corrected with glasses or contact lenses. It can range from mild visual difficulty to complete blindness. It can be caused by either congenital or acquired eye maldevelopments (PVI: peripheral VI) or disruptions in central visual pathways (CVI: cerebral VI). A recent meta-analysis highlights a striking global prevalence of VI in those under 20. Most PVIs stem from genetic issues, like hereditary retinal dystrophies. In contrast, CVI involves damage to post-geniculate visual pathways due to factors like birth hypoxic-ischemic damage, and, as such, is very frequent in children with cerebral palsy. Up to 70% of individuals with genetic syndromes (such as Down Syndrome and other neurodevelopmental disorders) have VI. For this study in particular, children and adolescents with a moderate CVI and children and adolescents with a moderate visual impairment according to the definitions of the World Health Organizations Report on Vision, who have functional impairments that require adjustments, tools and/or support at school will be included. Children and adolescents whose vision can be corrected with glasses and/or contact lenses do not fit the requirement of this study. VI significantly impacts psychological, educational, and social performance, adding mental burden and affecting individuals' quality of life (QoL). In this regard, children with VI experience worse QoL than population-based samples, body image development and mental and social well-being.

Regarding body image development, children and adolescents with VI face unique challenges in developing their body image compared to their unaffected peers. Body image development is a crucial developmental task during childhood, marked by significant biological (e.g., development of secondary sex characteristics), cognitive (e.g., increased self-reflection skills), and psychosocial changes (e.g., heightened importance of peer relationships), directing children's focus toward their evolving physical bodies. Children and adolescents with VI are at a heightened risk of developing negative body image, influenced by various challenges across different contexts (i.e., personal, interpersonal including peer and parental relationships, and societal including media portrayal of appearance), contributing to feelings of differentiation from their unaffected peers. Scholars have advocated to more systematically explore and identify experiences of youth with VI that can nourish and/or harm their healthy body image development. Building on the identification of these experiences, amongst others, the VIPPSTAR project aims to offer the first holistic framework for a life-long enhancement of health, well-being, and autonomy of children and adolescents with VI of different degrees of severity. The VIPPSTAR project will do this through building an online platform, which will contain an avatar that will assist adolescents with VI in several elements of their life; nutrition, physical activity and body image. The current study will solely use the body image module of the platform.

While different factors contribute to body image development, one potentially profound socialization factor is social media. Social media play a dominant role in the lives of children and adolescents, especially visual platforms like Instagram, TikTok, Snapchat and YouTube. For people of all ages and with different types of VI, social media are known to play a big role in their lives. However, since the visual nature of these platforms, users are encouraged to present themselves in a physically attractive way. The idealized appearance images on these platforms typically reflect narrow beauty standards. Exposure to such idealized bodies on social media can lead to internalization of these ideals and adopting them as personal beliefs.

As adolescence marks period with a high risk for the development body image concerns, scholars have noted this developmental period as a key time for intervention. Furthermore, digital and/or mobile interventions have high potential for success for adolescents. Previous research additionally showed that having social media literacy can be a protective factor for body image. Consequently, the present intervention study will examine the effectiveness of doing weekly exercises on body image states in VI children and adolescents. This study specifically focuses on children and adolescents (10-18 years old old) since they are avid social media users. Furthermore, the development of body-related beliefs and behaviors are especially salient during this developmental stage. Additionally, interventions targeting body image and social media literacy have previously been shown to have a small effect in adolescents without a visual impairment. The primary study objective is therefore to explore if doing exercises about body image and social media literacy related to body image can improve the body image of children and adolescents with VI. Conducting this intervention study might lead to a more comprehensive approach of the development of these children and adolescents.

• Study Design and Objective 3.1 Study objective

• Primary objective: to test the effectiveness of a digital intervention on body image and (social) media literacy of children and adolescents with VI

3.2 Primary Endpoints This is a prospective, monocentric, academic single case experimental design (SCED) intervention study including children and adolescents with VI (aged 10-18), followed up at the Ophthalmology department and the Cerebral Palsy Reference Center of UZ Leuven, (specialized) schools and other expertise centres (see recruitment strategy and procedure below under '3.4 Recruitment'). The endpoints to evaluate our study objective are quantitative surveys in a single case experimental design (SCED), which are detailed and explained under '3.3 Study design'. All surveys will be self-reported by the youth with VI themselves. Before the start of the study, parents giving informed parental consent will be asked impairment-specific questions as they are expected to hold more accurate information about, for instance, the severity of visual impairment of their children. This procedure will be detailed further under '3.4 Recruitment and informed consent'.

3.3 Study design This study will implement a single case experimental design (SCED). In this design, repeated measures are taken from a small number of participants. This method is fitting for novel topics and hard to reach populations. Furthermore, this method can provide rich, high quality data that can reveal change processes within individuals that might otherwise be masked in larger randomized control trials. Instead of finding statistical power by studying a large sample, statistical power is found in measuring the same variables in the same select group of participants repeatedly. Since the goal of this intervention is to study changes in body image and social media literacy in children and adolescents with VI, the SCED is an apt method for this intervention study. In our study, we aim to initially recruit 15 participants. In this way, if some participants stop participating during the study, there are still enough participants included for a SCED. In published psychology papers implementing SCED, it is common to have five to ten participants, evidence in SCED should generally have at least three demonstrations of an effect at different points in the duration of the study or across different participants. However in the current study, we would like to include more participants than three due to the high heterogeneity of the target population.

In SCED, a study is divided into different phases. Each phase needs at least 5 measuring moments to be able to conduct statistical analysis and compare phases within each individual participant. This intervention study will be divided into the pre-intervention phase (phase A) and the intervention phase (phase B). Phase A will start two weeks before the start of the intervention. Participants will be asked to fill in the pre-intervention survey 5 times during this phase, forming the baseline measure. Phase B will start from the first Monday of the first week of the intervention. During Phase B, participants will be asked to fill in same survey twice a week, after the completion of each body image exercise (2 per week). Hence, after the three weeks of the intervention, all the variables in the survey will be measured 6 times during the Phase B. Lastly, in two and a half weeks post-intervention, participants will be asked to fill in the survey 5 more times, making 10 measurements in Phase B in total.

In this study, repeated measurements will be taken of body image and social media literacy state variables (State self-esteem, state body satisfaction, state body surveillance, state functionality appreciation, state social media physical appearance comparisons, state cognitive social media literacy and state affective social media literacy). These variables will be measured 16 times during the study (5 times during phase A, 6 times during phase B and 5 times during phase C). As a pre-measure, the concepts of illness identity and perceived physical health are additionally measured to assess the child's/adolescent's feelings about their visual impairment and health. Measuring these concepts will provide some important contextual information about the participant, however they are less fitting to be adjusted to daily measures. Furthermore, the intervention does not focus on improving these variables. Hence, they are only measured as a pre-measure the first time participants complete the survey.

The intervention exercises are aimed at improving body image and social media literacy related aspects. The exercises do this by not only making the participant learn about what body image is and how social media can impact body image, but also by letting the participant actively think and write about their body image and strategies they can imply to combat negative feelings they might experience because of social media. Actively thinking about these matters has been proven effective for body image components in other intervention studies. The survey will assess daily state measures for self-esteem and several body image and social media literacy variables (State self-esteem, state body satisfaction, state body surveillance, state functionality appreciation, state social media physical appearance comparisons, state cognitive social media literacy and state affective social media literacy). These variables will be measured daily since we expect the interventions to significantly improve the average of these variables in the different phases of this SCED study. A detailed description of the survey and intervention exercises is given under '3.8 Surveys and intervention material'.

3.4 Recruitment

The selection criteria for participation in our research project are: (1) participants must be between the ages of 10 and 18, (2) participants must have a VI, (3) must be proficient in the Dutch language, and (4) must be active on digital (social) media platforms such as Instagram, Facebook, TikTok and YouTube and/or online social gaming platforms such as Roblox and Minecraft. Expressing interest in our study does not entail any obligation to participate. This will also be clearly communicated in the information letters distributed to interested participants/parents of participants during the recruitment. Furthermore, participants can decide to withdraw from the study at any time. Below, we will detail the specific procedure. We will search for interested adolescents with VI through the following methods:

• Contacting schools across Flanders;
• Collaborate with the Child Ophthalmology Department and the CP Reference Centre UZ Leuven;
• Contacting other existing organizations in Flanders that support children and adolescents with visual impairment;
• Contacting opthalmologists across Flanders;
• Implement snowball sampling.

3.5 Informed consent Prior to the study, active parental consent will be requested for the participants who are under the age of 18. Parents of interested children and adolescents will be given the (digital) information letter. Active parental consent will be obtained via a link/QR-code in the information letter linked to a survey in LimeSurvey, where parents will give permission for their child to participate in the study. Furthermore, the survey will contain some questions for the parents about information about their child. A detailed description of this survey can be found under '3.8 Surveys and intervention material'. Total time for this background survey for parents is estimated at 10 minutes. This survey includes socio-demographic information and information about the visual impairment. This information is asked from the parents since their child might not know the specific cause for their impairment, especially the younger cohort of the age range. This information is important for the research team to report in the scientific paper. Furthermore, since we aim for balanced distribution based on age and gender, it is crucial to inquire about socio-demographic characteristics. In the case that children/adolescents themselves are assigned to the survey through one of the recruitment methods, they will be asked to first ask their parents to fill in the parental informed consent form. Importantly, we do not create or store a separate database of parental contact details. Only parents who actively express interest in participation provide their information voluntarily and for the sole purpose of enabling their child's participation in the study. This information is not retained beyond the scope of the study.

Before the start of the study, all children and adolescents that will participate will be asked for informed assent/consent before the start of the study. The accompanying information letter will inform participants about the research objectives, the types of questions being asked, the fact that their participation is voluntary, and that non-participation in the study will have no negative consequences, as well as how the confidential data processing will be handled. Furthermore, it will be made clear that participants can decide to withdraw from the study at any time. The informed assent/consent form will be completed by each participant prior to the start of the study (via the online link, using a speech software if necessary). In the case of the recruitment of adolescents who are 18 years of age, this will be the only type of informed consent obtained. These adolescents will be asked to ask one of their parents to fill in the background survey with the socio-demographic and visual impairment information. All informed consent/assent letters are provided in the submission of this ethical submission in the portal.

3.6 Study procedure for participants The present study involves the organization of a three-week intervention study, with an additional pre-intervention measuring period of 2 weeks and a post-measurement period 2,5 weeks after the completion of the intervention. After the collection of informed (parental) consent, the child/adolescent will be sent an email with instructions for their participation in the study via the provided email address. This email address was provided by the parent during parental consent, or in the case of 18-year-old participants, by the participant themselves. Only those children from whom we receive both parental consent and active informed assent will be sent this email. The email will contain a repetition of the study procedure (pre-intervention phase, intervention phase with three weeks of online exercises in the VIPPSTAR app and post-intervention phase), practical information about when the data collection will start and how to install the VIPPSTAR app. The VIPPSTAR app downloaded by participants for this study will solely contain the body image module. No other modules or functionalities will be present.

Once the app is installed, the participant will receive a notification to let them know the app was installed correctly. On the day before the start of the data collection, the participant will receive a notification to remind them that on the next day, they will fill in the survey for the first time. The pre-intervention survey will be filled in 5 times during the 2 weeks before the start of the intervention (Phase A). During the first time, socio-demographic questions will be asked. Total time for the first time participants fill in this survey is estimated at approximately 10-20 minutes. After this first time, average time for completing the survey is estimated at approximately 5-10 minutes. A detailed description of this survey and its included variables can be found under '3.8 Surveys and intervention material'. Next, participants will start the intervention phase (Phase B) during which they complete the bi-weekly intervention exercises in the VIPPSTAR app/platform. In this app, participants will be informed and guided through the exercises by the VIPPSTAR Avatar. A detailed description of this platform will be given under '3.6 VIPPSTAR Platform'. During this phase, participants will complete the survey 6 times (twice a week). Next, the post-intervention phase will start. During this phase of 2,5 weeks, the participants will complete the survey an additional 5 times.

As a compensation for the intensity of participating in this study, participants will receive a compensation of a maximum of €40 in gift cards. We will implement a system in which participants who completed all surveys and intervention exercises will receive the full amount of gift cards. Participants earn €10 for each completed week of the intervention, with a bonus of another €10 if they compete all the surveys and intervention exercises.

3.7 VIPPSTAR platform The platform and the avatar will be built by the Italian company Spindox Labs. Spindox Labs is the research and innovation division of Spindox S.p.A., operating at the intersection of research and industrial innovation. Through collaborations with universities, public and private institutions, and innovative start-ups, it designs and delivers advanced digital solutions, contributing to European and national initiatives in AI, data-driven systems, and next-generation human-machine interaction.

In the case of the body image intervention study, the exercises will be provided through a prototype version of the VIPPSTAR app. This prototype will only contain a pre-programming of the body image exercises. These body image exercises were designed by the KU Leuven research team, without any interference of other partners within the VIPPSTAR project or Spindox Labs. Participants will download this app to participate in the surveys and intervention exercises. The avatar will both provide its messages in text and audio. What the avatar says will be saved in the app, so the participant is able to reread the messages of the avatar as much as they want. Furthermore, participants will be able to give their answers to the avatar both by typing or using the speech-to-text function. The app will give notifications to remind the participant to complete the exercises and to fill in the surveys. Report data will be stored temporarily within the local app on the user's device to improve usability. Each exercise consists of several steps, allowing the user to navigate through them or return to previously completed ones. Once the report is finalized, the data is transmitted to the server of the university of Trento and deleted from the local device. While in local storage, data is handled according to GDPR guidelines for sensitive and emotional information. This includes encryption, password protection, and the prevention of screenshots, alongside all other features required to ensure full GDPR compliance. All data will fully and solely be stored at the university of Trento. Spindox Labs will not store any data of the participants in the study.

Furthermore, the survey questions will be asked directly in the app, so the participant can remain in the same environment for the whole of their participation in the intervention study. We opted for this so the participant does not have to leave the digital environment during the study to fill in the survey, making their participation as easy as possible for them. This data will also be fully and solely stored at the university of Trento. Spindox Labs will not store any data of the participants in the study.

3.8 Surveys and intervention material The used surveys and intervention materials are included in the Study Documents of this case.

• Time frame of the Intervention Study Data collection will be planned between 1/10/2026 (the start date will be adjusted depending on when ethical approval and final version of the intervention software will be obtained) and 31/12/2027.

• Study Population / Eligibility Criteria 5.1 Inclusion criteria

Participants for the VI sample eligible for inclusion in this study must meet all of the following criteria:

• Children with (C)VI
• Participants should be aged between 10-18 years old
• Participants should be able to understand Dutch sufficiently
• Participants should be cognitively able to comprehend the questions
• A completed ICF by the parent if the participant is under 18 years of age and a completed assent form by the participant

5.2 Exclusion criteria

Participants eligible for this study must not meet any of the following criteria:

• Intellectual disability of such severity that they are unable to respond to the questions (as indicated by parents)
• Non-Dutch Speaking (as indicated by parents)

6 Data Analysis Statistical analysis will be conducted using R by PhD student Esmée Mooren. Data will be analyzed using Shiny SCDA31 and will be divided into three phases: Phase A (baseline; data collected before the intervention), Phase B (data collected during the intervention) and Phase C (data collected after the intervention). Data endpoints (state self-esteem, state body satisfaction, state body surveillance, state functionality appreciation, state social media physical appearance comparisons, state cognitive social media literacy and state affective social media literacy) will be analyzed within participants by examining key features of data patterns. First, the level of each variable within each phase will be mapped per participant by calculating the median within each phase. The median is preferred over the mean, since it is less influenced by extreme values. Second, the variability will be measured by mapping the range of scores within each phase. Furthermore, variance ratios between consecutive phases will be calculated of each variable per participant (e.g. B/A, C/B). Values below 1.00 suggest that this variability is lower during the phase that is being compared, which may suggest that scores have become more consistent. Third, trends will be inspected using regression lines within each phase (ordinary least squares regression). Finally, effect size estimates will be calculated using non-overlap of all pairs (NAP), and pooled standardized mean difference (PSMD) to quantify changes between phases. NAP quantifies the degree of the overlap in data points between the phases in SCED from 0 to 100%. When the NAP is high, it suggests a greater degree of overlap in the data points between phases. This suggests a stronger intervention effect. The benchmarks are 0 to 65% for a small effect, 66 to 92% for a medium effect and 93 to 100% for a large effect. To calculate the PSMD, the mean score of the measured variables in Phase A is subtracted of the mean of the scores in Phase B (and the same when comparing Phase C and Phase B). The difference is divided by the pooled standard deviation. The benchmarks for PSMD are akin to Cohen's effect size d (0.20 = small, 0.50 = medium, 0.80 = large). Any missing data points will not be imputed, but analyses will be conducted based on the available data points. The total number and timing of missing data points will be reported. After analyzing each participant, we will evaluate whether there are demonstrations of improvement across participants following the intervention sequence. This entails examining whether at least six participants show improvements in SML and body image outcomes following the intervention.

7 Data handling 7.1 General data handling information Data collection, handling, processing and transfer for the purpose of this study will be performed in compliance with applicable regulations, guidelines for clinical studies and internal procedures. It remains the responsibility of the Investigator to check that all data relating to the Study, as specified in the Study protocol, are entered into the electronic Case Report Form ((e)CRF) in accordance with the instructions provided and that the forms are filled out accurately, completely and in a timely manner.

(e)CRFs are provided by the Sponsor for each participant. The Study data will be transcribed from the source records into an (e)CRF by Study Staff.

The (e)CRFs shall under no circumstances capture personal data such as but not limited to the participant or their relative(s) name, home address, contact details, full date of birth medical record number (e.g. UZ Leuven EAD number), social security number etc.

7.2 Study specific data handling information Data will be pseudonymized and will be stored on a protected and encrypted server at KU Leuven to ensure further security and confidentiality.The data will be kept for 25 years. Furthermore, a data transfer agreement is currently being set up by the LRD of the KU Leuven between the Italian university of Trento (UNITN) and KU Leuven. The intervention platform data will be stored by Spindox Labs at UNITN.

8 Ethical and Regulatory Considerations

8.1 Ethics Committee (EC) review & reports Before the start of the Study, this protocol and other related documents will be submitted for review to the EC for Study authorization. The Study shall not commence until such approvals have been obtained and until other relevant essential Study documents, such as duly signed contract agreements, evidence of adequate Study financing etc. are in place.

8.2 Protocol / GCP compliance The Study must be performed in accordance with the protocol, current ICH and ICH-GCP guidelines, and applicable regulatory and country-specific requirements. ICH guidelines are an international ethical and scientific quality standard for designing, conducting, recording, and reporting studies that involve the participation of human participants. Compliance with this standard provides public assurance that the rights, safety, and well-being of Study participants are protected, consistent with the principles that originated in the most recent version of the Declaration of Helsinki, and that the Study data are credible, reliable and reproducible.

8.3 Data protection and participant confidentiality The Study will be conducted in compliance with the requirements of the EU General Data Protection Regulation 2016/679 (GDPR), and the relevant Belgian laws implementing the GDPR including the Belgian Privacy Act of 30 July 2018 on the protection of privacy in relation to the processing of personal data. Any collection, processing and disclosure of personal data, such as participant health and medical information is subject to compliance with the aforementioned personal data protection laws (cfr. Data Processing Annex (DPA) in Appendix). In case personal data is transferred outside the European Economic Area, safeguards will be taken by the Sponsor to ensure that appropriate protection travels with the data in accordance with the GDPR. (https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/rules-international-data-transfers_en#documents) Any personal data shall be treated as confidential at all times including during collection, handling and use or processing, and the personal data (including in any electronic format) shall be stored securely at all times and with all technical and organizational security measures that would be necessary for compliance with EU and national data protection legislation (whichever is more stringent). The Sponsor shall take appropriate measures to ensure the security of all personal data and guard against unauthorized access thereto or disclosure thereof or loss or destruction while in its custody.

9 Research Registration, Dissemination of Results and Publication Policy

The Declaration of Helsinki (latest version) and European and Belgian regulations require that every research Study involving human participants be registered in a publicly accessible database before recruitment of the first participant. The CI is responsible for registering the Study.

In addition, the CI will fulfil their ethical obligation to disseminate and make the research results publicly available. As such the CI is accountable for the timeliness, completeness and accuracy of the reports. Researchers, authors, Sponsors, editors and publishers must adhere to accepted guidelines for ethical reporting. Negative and inconclusive, as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in publication.

Publications will be coordinated by the CI. Authorship to publications will be determined in accordance with the requirements published by the International Committee of Medical Journal Editors and in accordance with the requirements of the respective medical journal.

10 Joint Commission International (JCI)

In order to ensure the same quality and safety standards in patient care for clinical research as commonly applied by the Sponsor in its regular activities, and in accordance with JCI standards, the Sponsor shall comply with the following obligations: (a) the Sponsor will use trained and qualified employees or contractors to manage and coordinate the Study; (b) the Sponsor will ensure that multi-center Study reporting is reliable and valid, statistically accurate, ethical, and unbiased. (c) the Sponsor will not grant incentives, other than standard compensations and reimbursement of costs, to Study participants or to participating site's staff that would compromise the integrity of the research; (d) the Sponsor is responsible for monitoring and evaluating the quality, safety, and ethics of the Study and will respect the participating site's policies and processes when performing such monitoring and evaluation activities; (e) the Sponsor will protect the privacy and confidentiality of the Study participants in accordance with all applicable laws.

11 Safety Reporting

The sponsor will assess whether any relevant safety information that becomes available during the study should be reported ad hoc to EC. An overview of all Serious Adverse Reactions (= Serious Adverse Events related to the study-specific interventions) occurred during the reporting period will be listed in the Final Study Report.

Inclusion criteria

• Children with (C)VI
• Participants should be aged between 10-18 years old
• Participants should be able to understand Dutch sufficiently
• Participants should be cognitively able to comprehend the questions
• A completed ICF by the parent if the participant is under 18 years of age and a completed assent form by the participant

Exclusion criteria

• Intellectual disability of such severity that they are unable to respond to the questions (as indicated by parents)
• Non-Dutch Speaking (as indicated by parents)