NCT07165704

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 3, 2025

Last Update Submit

September 9, 2025

Conditions

Keywords

Self-conceptHealth-related quality of lifeQuality-adjusted life yearsPsychological adjustmentArts-based interventionVisual artsCost-utility

Outcome Measures

Primary Outcomes (1)

  • 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).

    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.

    Baseline and 9 months

  • Quality-adjusted life years (QALY) gains from baseline as assed by the Child Health Utility 9 Dimensions.

    Baseline and 9 months.

Other Outcomes (1)

  • Change from baseline on children´s use of societal resources

    Baseline and 9 Months

Study Arms (2)

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.

Other: Visual arts

Waitlist Control

NO INTERVENTION

Interventions

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.

Also known as: Community Galleries
Visual Art Intervention

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Cognitive deficit, neurological disease or global developmental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Associação de Solidariedade da Zona das Fontainhas

Porto, 4000-527, Portugal

Location

Espaço Raíz

Porto, 4100-029, Portugal

Location

Escola do Parque Centro de Bem-estar Social Nossa Senhora do Socorro

Porto, 4100-033, Portugal

Location

A Associação de Promoção Social da População do Bairro do Aleixo

Porto, 4150-193, Portugal

Location

ASAS (Associação de Solidariedade e Ação Social de Ramalde)

Porto, 4250-323, Portugal

Location

Paróquia de Nossa Senhora da Ajuda - Pasteleira

Porto, 4300-004, Portugal

Location

Escola Básica do Falcão

Porto, 4300-178, Portugal

Location

Centro Social do Lagarteiro

Porto, 4300-282, Portugal

Location

Escola Básica de Montebello

Porto, 4350-280, Portugal

Location

Escola Básica de São Roque da Lameira

Porto, 4350-297, Portugal

Location

Study Officials

  • Sandra P Henriques, Mastre

    Associação Para o Apoio e Integração Social e Comunitária

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 10, 2025

Study Start

February 26, 2024

Primary Completion

February 28, 2025

Study Completion

July 2, 2025

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations