Self-conceptNCT07165704
Community Galleries - Art and Children in Action: Study Protocol
A study testing Visual arts in people with Self-concept and Psychological Adjustment, run by Associação para o Apoio à Integração Social e Comunitária at 10 sites in Portugal.
Trial summary
The goal of this trial is to evaluate whether a community-based visual arts intervention can improve self-concept, psychological adjustment, and health-related quality of life (HRQoL) in children aged between 6 and 12, from socioeconomically disadvantaged neighborhoods. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-concept, Psychological Adjustment, Health Related Quality of Life
- What is being tested?
- Visual arts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 10 sitesPortugal
- Study dates
- 26 Feb 2024to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- To be enrolled in elementary school and registered as a participant or student in one of the 10 schools or institutions, partners of the Community Galleries project.
Who cannot join
- Cognitive deficit, neurological disease or global developmental disorder
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Portugal10 sites
Associação de Solidariedade da Zona das Fontainhas
Porto, 4000-527
Espaço Raíz
Porto, 4100-029
Escola do Parque Centro de Bem-estar Social Nossa Senhora do Socorro
Porto, 4100-033
A Associação de Promoção Social da População do Bairro do Aleixo
Porto, 4150-193
ASAS (Associação de Solidariedade e Ação Social de Ramalde)
Porto, 4250-323
Paróquia de Nossa Senhora da Ajuda - Pasteleira
Porto, 4300-004
Escola Básica do Falcão
Porto, 4300-178
Centro Social do Lagarteiro
Porto, 4300-282
Escola Básica de Montebello
Porto, 4350-280
Escola Básica de São Roque da Lameira
Porto, 4350-297
About this study
Official title: Community Galleries - Art and Children in Action: Protocol for a Cluster Non-Randomized Controlled Trial of an Art-Based Intervention to Promote Child Psychological Adjustment, Self-Concept and Quality of Life
The goal of this trial is to evaluate whether a community-based visual arts intervention can improve self-concept, psychological adjustment, and health-related quality of life (HRQoL) in children aged between 6 and 12, from socioeconomically disadvantaged neighborhoods.
The main questions it aims to answer are:
Read more
- Does the intervention improve children's psychological adjustment, as the primary outcome?
- Does the intervention improve self-concept and health-related quality of life (HRQoL) as the secondary outcomes?
- Is the intervention cost-effective compared to the waitlist control?
Researchers will compare children receiving the visual arts intervention (intervention group) with children not receiving the intervention (waiting list control group) to see if the program leads to measurable improvements in psychological adjustment, self-concept, and health-related quality of life.
Participants will:
- Take part in one-hour weekly visual arts sessions for nine months, led by professional artists;
- Participate in community art exhibitions at the end of the program;
- Complete questionnaires on psychological adjustment, self-concept, HRQoL, and societal resource use at baseline and post-intervention;
- Teachers/technicians will complete questionnaires on children's psychological adjustment.
- Being tested
- Visual arts
- Keywords
- Self-concept, Health-related quality of life, Quality-adjusted life years, Psychological adjustment, Arts-based intervention, Visual arts, Cost-utility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual artsOther
Also called Community Galleries
The arts intervention will consist of two parts: (a) implementation of one-hour session of Visual Arts (e.g., painting, drawing, printing techniques exercises). The activities will be guided through a theme (Emotions), by a professional artist, to obtain a final individual artistic product. Peer contact, shared learning, and a feeling of community are all made possible by the group-based approach. This facilitator will offer assistance, motivation, and technical training as they lead participants through the creative process. Using narrative-building and dialogue-based methods, the artist will encourage children to share their stories, experiences, and perspectives, through art. (b) Children's final artistic products will be displayed in Community Galleries in their neighbourhood in an opening ceremony.
| Study group | Role | What they receive |
|---|---|---|
| Visual Art Intervention | Experimental | The arts intervention will consist of two parts: (a) implementation of one-hour session of Visual Arts (e.g., painting, drawing, printing techniques exercises). (b) Children's final artistic products will be displayed in Community Galleries in their neighbourhood in an opening ceremony. Receives: Other: Visual arts |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the total difficulties as assessed by The Strengths and Difficulties Questionnaire.
The Strengths and Difficulties Questionnaire (SDQ) produces a total difficulties score ranging from 0 to 40, with higher scores indicating greater difficulties. It also comprises five subscales, each scored from 0 to 10: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Relationship Problems, and Prosocial Behaviour (for which higher scores indicate more prosocial behaviours).
Measured: Baseline and 9 months
Secondary outcomes (2)
Change from baseline of Self-concept as assed by The Self-Perception Profile for Children and the The Pictorial Scale of Perceived Competence and Social Acceptance for Young Children.
This outcome is mesured with a) The Self-Perception Profile for Children (SPPC) produces domain-specific scores and a global self-worth score, each ranging from 1 (lowest perceived self-concept) to 4 (highest perceived self-concept). The scale includes six domains: Scholastic Competence, Social Acceptance, Athletic Competence, Physical Appearance, Behavioural Conduct, and Global Self-Worth. For children 7 years old and over; and b) The Pictorial Scale of Perceived Competence and Social Acceptance for Young Children produces scores for four domains: Cognitive Competence, Physical Competence, Peer Acceptance, and Maternal Acceptance, each ranging from 1 (lowest perceived competence or acceptance) to 4 (highest perceived competence or acceptance), for chindren under 7 years.
Measured: Baseline and 9 months
Quality-adjusted life years (QALY) gains from baseline as assed by the Child Health Utility 9 Dimensions.
To assess this outcome, the Child Health Utility 9 Dimensions is a health-related quality of life (HRQoL) measure designed for use in children. The CHU9D captures nine dimensions: worry, sadness, pain, tiredness, annoyance, schoolwork, sleep, routine, and activities. For each dimension, a five-level ordinal scale is used from 1 (no problems) to 5 (severe problems). Intended for use in cost-effectiveness evaluations of youth-focused treatment and assistance initiatives the instrument derives a single utility score of the health state experienced by the child from preference weights. CHU9D utility scores will be used to estimate QALYs (Quality Of Life in Years) for children over the study period using the area under the curve method. The range of utility scores is from 0 (where it will be equal to dead state) to 1 (where it will be in perfect health state), which is a part of cost-utility analysis, especially in economic evaluation.
Measured: Baseline and 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start26 Feb 2024
- Primary completion28 Feb 2025
- Study completion2 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self-conceptStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associação para o Apoio à Integração Social e Comunitária
- Sponsor type
- University, hospital or other
- Collaborators
- Calouste Gulbenkian Foundation, Uppsala University, Lusofona University
- Responsible party
- Sponsor
- Investigators
- Sandra P Henriques, Mastre, Principal investigator, Associação Para o Apoio e Integração Social e Comunitária
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165704
- Sponsor's protocol ID
- ESPACOT1220425
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Henriques S, Pinto R, Oliveira J, Sampaio F. Art-Based Intervention to Promote Psychological Adjustment, Self-Concept, and Quality of Life in Children: Protocol for a Cluster Nonrandomized Controlled Trial. JMIR Res Protoc. 2026 Aug 12;15:e84994. doi: 10.2196/84994.
PubMed 42585664
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Galleries - Art and Children in Action: Protocol for a Cluster Non-Randomized Controlled Trial of an Art-Based Intervention to Promote Child Psychological Adjustment, Self-Concept and Quality of Life
- ClinicalTrials.gov ID
- NCT07165704
- Acronym / sponsor ID
- ESPACOT1220425
- Keywords
- Self-concept, Health-related quality of life, Quality-adjusted life years, Psychological adjustment, Arts-based intervention, Visual arts, Cost-utility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Associação para o Apoio à Integração Social e ComunitáriaUniversity, hospital or other
- Collaborators
- Calouste Gulbenkian Foundation, Uppsala University, Lusofona University
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 2 Jul 2025 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial is to evaluate whether a community-based visual arts intervention can improve self-concept, psychological adjustment, and health-related quality of life (HRQoL) in children aged between 6 and 12, from socioeconomically disadvantaged neighborhoods.
The main questions it aims to answer are:
- Does the intervention improve children's psychological adjustment, as the primary outcome?
- Does the intervention improve self-concept and health-related quality of life (HRQoL) as the secondary outcomes?
- Is the intervention cost-effective compared to the waitlist control?
Researchers will compare children receiving the visual arts intervention (intervention group) with children not receiving the intervention (waiting list control group) to see if the program leads to measurable improvements in psychological adjustment, self-concept, and health-related quality of life.
Participants will:
- Take part in one-hour weekly visual arts sessions for nine months, led by professional artists;
- Participate in community art exhibitions at the end of the program;
- Complete questionnaires on psychological adjustment, self-concept, HRQoL, and societal resource use at baseline and post-intervention;
- Teachers/technicians will complete questionnaires on children's psychological adjustment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Art Intervention | Experimental | Other: Visual artsThe arts intervention will consist of two parts: (a) implementation of one-hour session of Visual Arts (e.g., painting, drawing, printing techniques exercises). (b) Children's final artistic products will be displayed in Community Galleries in their neighbourhood in an opening ceremony. |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- To be enrolled in elementary school and registered as a participant or student in one of the 10 schools or institutions, partners of the Community Galleries project.
Key exclusion criteria (1 listed)
- Cognitive deficit, neurological disease or global developmental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual artsAlso: Community GalleriesThe arts intervention will consist of two parts: (a) implementation of one-hour session of Visual Arts (e.g., painting, drawing, printing techniques exercises). The activities will be guided through a theme (Emotions), by a professional artist, to obtain a final individual artistic product. Peer contact, shared learning, and a feeling of community are all made possible by the group-based approach. This facilitator will offer assistance, motivation, and technical training as they lead participants through the creative process. Using narrative-building and dialogue-based methods, the artist will encourage children to share their stories, experiences, and perspectives, through art. (b) Children's final artistic products will be displayed in Community Galleries in their neighbourhood in an opening ceremony. | Other | Visual Art Intervention |
Primary outcome
Change from baseline in the total difficulties as assessed by The Strengths and Difficulties Questionnaire.
Time frame: Baseline and 9 months
The Strengths and Difficulties Questionnaire (SDQ) produces a total difficulties score ranging from 0 to 40, with higher scores indicating greater difficulties. It also comprises five subscales, each scored from 0 to 10: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Relationship Problems, and Prosocial Behaviour (for which higher scores indicate more prosocial behaviours).
2 secondary outcomes
Change from baseline of Self-concept as assed by The Self-Perception Profile for Children and the The Pictorial Scale of Perceived Competence and Social Acceptance for Young Children.
Time frame: Baseline and 9 months
Quality-adjusted life years (QALY) gains from baseline as assed by the Child Health Utility 9 Dimensions.
Time frame: Baseline and 9 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 42585664Henriques S, Pinto R, Oliveira J, Sampaio F. Art-Based Intervention to Promote Psychological Adjustment, Self-Concept, and Quality of Life in Children: Protocol for a Cluster Nonrandomized Controlled Trial. JMIR Res Protoc. 2026 Aug 12;15:e84994. doi: 10.2196/84994.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra P Henriques, Mastre principal investigator
Associação Para o Apoio e Integração Social e Comunitária
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual arts in people with Self-concept and Psychological Adjustment, run by Associação para o Apoio à Integração Social e Comunitária at 10 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the total difficulties as assessed by The Strengths and Difficulties Questionnaire. (time frame: Baseline and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07165704, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.