Using an arts-based program to reduce mental-health-related stigma in young people

ISRCTN ISRCTN65217320
DOI https://doi.org/10.1186/ISRCTN65217320
Secondary identifying numbers LCF/PR/SR22/52570002
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

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

Study website

Contact information

Prof Ana Beato
Public, Scientific, Principal Investigator

Universidade Lusófona, Campo Grande 380
Lisbon
1700-097
Portugal

ORCiD logoORCID ID 0000-0003-3177-3578
Phone +351 967482475
Email ana.beato@ulusofona.pt

Study information

Study designMixed-method explanatory nested-design combining qualitative and quantitative methods study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeOther
Participant information sheet ISRCTN65217320 PIS and data collection form.pdf
Scientific titleWeARTolerance: 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 acronymWeARTolerance
Study hypothesisThe 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

ConditionRedution of mental-health-related stigma in young people
InterventionAfter 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 typeMixed
Primary outcome measureSocial 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)
Secondary outcome measuresThe 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):
1. Knowledge of mental health measured using the Mental Health Knowledge Schedule (MAKS)
2. Social distance measured using the Social Distance Scale
3. Intergroup anxiety measured using the Intergroup Anxiety Scale
Overall study start date01/10/2022
Overall study end date30/06/2024

Eligibility

Participant type(s)Population
Age groupMixed
Lower age limit11 Years
Upper age limit24 Years
SexBoth
Target number of participants210
Total final enrolment151
Participant inclusion criteria1. 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
Participant exclusion criteriaSignificant cognitive, motor, and speech impairments that might hinder the completion of the activities
Recruitment start date01/03/2023
Recruitment end date11/06/2023

Locations

Countries of recruitment

  • Portugal

Study participating centre

HEI-Lab - Universidade Lusófona
Campo Grande 380
Lisbon
1700-097
Portugal

Sponsor information

Universidade Lusófona
University/education

Campo Grande 380
Lisbon
1700-097
Portugal

Phone +351 217 515 500
Email hei-lab@ulusofona.pt
Website https://hei-lab.ulusofona.pt/
ROR logo "ROR" https://ror.org/05xxfer42

Funders

Funder type

Charity

'la Caixa' Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Caixa Foundation, Fundación Caixa, 'la Caixa', Fundación Bancaria Caixa d'Estalvis i Pensions de Barcelona, Fundación 'la Caixa', Fundação 'la Caixa', Fundación Bancaria Caixa d'Estalvis i Pensions de Barcelona, 'la Caixa'
Location
Spain

Results and Publications

Intention to publish date30/06/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planPlanned presentations at conferences and publications in high-impact peer-reviewed journals. The first paper was already submtitted to Plus One Journal.
IPD sharing planThe 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

Additional files

ISRCTN65217320 PIS and data collection form.pdf

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.