Using an arts-based program to reduce mental-health-related stigma in young people
| ISRCTN | ISRCTN65217320 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65217320 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | LCF/PR/SR22/52570002 |
| Sponsor | Universidade Lusófona |
| Funder | 'la Caixa' Foundation |
- Submission date
- 26/04/2024
- Registration date
- 02/05/2024
- Last edited
- 15/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The stigma surrounding mental health remains a significant barrier to help-seeking and well-being in youth populations. The invisibility of mental health issues highlights the critical need for improved knowledge and stigma reduction, underscoring the urgency of tackling this issue. Arts-based interventions have shown promise in addressing stigma, yet comprehensive longitudinal studies in community settings are limited. This research evaluates the "WeARTolerance'' arts-based program in reducing mental-health-related stigma among diverse youths.
Who can participate?
Teenagers and young adults aged between 11 and 24 years old who speak Portuguese, live in Portugal and are willing to participate in an arts-based program
What does the study involve?
Participants are randomly assigned to one of eight smaller groups according to age and developmental level (teenagers: 11-16 years old and young adults: 17-24 years old). The program consists of 12 sessions over four sequential full days. Each of the four days starts with a psychoeducational session led by the psychology team, followed by two sessions among visual arts, cinema, music, and theatre sessions, one in the morning and the other in the afternoon. Participants will be assessed using questionnaires at three time points (the week before the program, the week after the program and six months after the program).
What are the possible benefits and risks of participating?
Participants benefit from the group sessions and have the opportunity to reflect and increase knowledge about mental health and mental-health-related stigma using an arts-based approach. No risks are anticipated from participation in the program.
Where is the study run from?
Lusófona University, Lisbon, Portugal.
When is the study starting and how long is it expected to run for?
October 2022 to June 2024
Who is funding the study?
“la Caixa” Foundation (Portugal)
Who is the main contact?
Ana Beato, ana.beato@ulusofona.pt
Contact information
Public, Scientific, Principal investigator
Universidade Lusófona, Campo Grande 380
Lisbon
1700-097
Portugal
 ORCID ID |
0000-0003-3177-3578 |
|---|---|
| Phone | +351 967482475 |
| ana.beato@ulusofona.pt |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Mixed-method explanatory nested-design combining qualitative and quantitative methods study |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | ISRCTN65217320 PIS and data collection form.pdf |
| Scientific title | WeARTolerance: evaluating the impact of an arts-based program to reduce mental health-related stigma among teenagers and young adults in Portugal, employing a mixed-method study in two phases |
| Study acronym | WeARTolerance |
| Study objectives | The arts-based program will increase the knowledge about mental health and decrease the social stigma related to mental health, intergroup anxiety towards individuals with mental health conditions and desire for social distance from individuals with mental health conditions. |
| Ethics approval(s) |
Approved 08/03/2023, Ethics and Deontology Committee of the Psychology and Life Sciences of Lusófona University (Campo Grande, 376, Lisbon, 1749-024, Portugal; +351 217 515 500; ilind@ulusofona.pt), ref: CEDIC-2023-09-09 |
| Health condition(s) or problem(s) studied | Redution of mental-health-related stigma in young people |
| Intervention | After recruitment, participants will be randomly assigned to one of eight smaller groups based on age and developmental level: teenagers aged 11-16 and young adults aged 17-24. The allocation to groups will ensure a balanced representation of participants with mental health conditions. The program, designed to fit within official school vacations, will consist of 12 sessions spread over four consecutive full days. Questionnaires, administered via Qualtrics, will be distributed at three intervals: one week before the program (T1: Baseline), one week post-program (T2: Post-intervention), and six months post-program (T3: Follow-up). Participants will be randomly assigned to treatment groups using simple randomization (i.e., random number generators), ensuring no specific pattern or stratification. The intervention group will receive the active intervention, either one or two months after enrollment. The control group will consist of participants on the waiting list, who will not receive intervention during the assessment period but will eventually access the intervention. This design will involve four intervention groups and four control groups, each undergoing the same questionnaire administration at the three time points. The intervention sessions, facilitated by psychology and arts teams, will cover psychoeducational and artistic activities (i.e., visual arts, cinema, music and theatre). Additionally, select participants from the intervention groups will engage in focus groups to provide qualitative insights into their perceptions and satisfaction with the program. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Social stigma measured using the Attribution Questionnaire-9 (AQ-9) for adults and AQ-8-C for children and adolescents in the week before the program (T1: Baseline), the week after (T2: Post-intervention) and six months after the program (T3: Follow-up) |
| Key secondary outcome measure(s) |
The following secondary outcome measures will be assessed in the week before the program (T1: Baseline), the week after (T2: Post-intervention) and six months after the program (T3: Follow-up): |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Mixed |
| Lower age limit | 11 Years |
| Upper age limit | 24 Years |
| Sex | All |
| Target sample size at registration | 210 |
| Total final enrolment | 151 |
| Key inclusion criteria | 1. 11 to 24 years old; for participants aged under 18 years, it was also a criterion to have their legal guardian’s formal authorisation to participate 2. Speak Portuguese 3. Live in Portugal 4. Willing to participate in an arts-based program |
| Key exclusion criteria | Significant cognitive, motor, and speech impairments that might hinder the completion of the activities |
| Date of first enrolment | 01/03/2023 |
| Date of final enrolment | 11/06/2023 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Lisbon
1700-097
Portugal
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The dataset generated during the study will be stored in a publicly available repository: https://osf.io/hwrka/?view_only=b52e2475c9b145eda84d140188ee8102. The full dataset with all coded variables is available. In this randomized controlled trial (RCT) we incorporate surveys and focus groups, corresponding to various types of data, collected to evaluate the effectiveness, acceptability, and impact of interventions: (a) Survey Data, used to collect quantitative data on various aspects related to the intervention, outcomes, and participant characteristics (ex. demographic information; baseline measures: pre-existing conditions; outcome measures, such as changes in behavior, attitudes, knowledge, etc., before and after the intervention; adherence and satisfaction with the program and sessions provided. (b) Focus Group Transcripts: Focus groups are used to gather qualitative data through facilitated discussions among participants. Data stored from focus groups were: Transcripts: Verbatim records of the discussions, capturing participants' perspectives, experiences, and opinions related to the intervention; themes and patterns: Analysis of the transcripts to identify recurring themes, patterns, or insights relevant to the research questions; Quotes and excerpts; Audio or Video Recordings stored to ensure accuracy in capturing participants' responses and non-verbal cues. (c) Quantitative Analysis Results, including descriptive statistics, inferential tests (e.g., t-tests, ANOVA), and regression analyses stored along with relevant summary tables and figures. (d) Qualitative Analysis Results, such as thematic coding matrices, summaries of themes and subthemes, and illustrative quotes, are stored to support qualitative interpretations and conclusions. (d) Documentation and Administrative Data, including documentation related to the conduct of the trial, such as informed consent forms, study protocols, ethics approvals, and participant recruitment and retention records. (e) Data Management Documentation (i.e., information on data handling procedures, data cleaning, coding schemes, and data storage protocols to ensure data integrity and compliance with regulatory requirements). It is expected that most datasets, scripts and excerpts might be publicly available. Further material will be provided by the team after justified requests (e.g., survey data; transcripts). The program Toolkit will be soon protected by copyright. Any file containing personal or identifiable data will be shared (e.g., contacts, audio files, video files). Outputs stored in reposititiums with open access will be available for reuse without time restrictions (e.g., databases attached in publications). Written informed consent forms were signed by parents and minors before the intervention. Oral consents were obtained from all parties to participate in the focus groups. Each participant had a code and all the questionnaires were filled using that code in all phases. In the excerpts of focus groups, we used no names or identifiable descriptors. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 15/08/2024 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN65217320 PIS and data collection form.pdf
- Participant information sheet
Editorial Notes
15/08/2024: The participant information sheet was uploaded as an additional file.
01/05/2024: Study's existence confirmed by the Ethics and Deontology Committee of the Psychology and Life Sciences of Lusófona University.
