Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT07165704
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2025-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Community Galleries - Art and Children in Action: Study Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2025-09-03', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline on children´s use of societal resources', 'timeFrame': 'Baseline and 9 Months', 'description': 'A parent-reported resource use questionnaire will also be administered to collect information on children´s use of societal resources'}], 'primaryOutcomes': [{'measure': 'Change from baseline in the total difficulties as assessed by The Strengths and Difficulties Questionnaire.', 'timeFrame': 'Baseline and 9 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': 'Baseline and 9 months', 'description': '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.'}, {'measure': 'Quality-adjusted life years (QALY) gains from baseline as assed by the Child Health Utility 9 Dimensions.', 'timeFrame': 'Baseline and 9 months.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-concept', 'Health-related quality of life', 'Quality-adjusted life years', 'Psychological adjustment', 'Arts-based intervention', 'Visual arts', 'Cost-utility'], 'conditions': ['Self-concept', 'Psychological Adjustment', 'Health Related Quality of Life']}, 'descriptionModule': {'briefSummary': "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.\n\nThe main questions it aims to answer are:\n\n* Does the intervention improve children's psychological adjustment, as the primary outcome?\n* Does the intervention improve self-concept and health-related quality of life (HRQoL) as the secondary outcomes?\n* Is the intervention cost-effective compared to the waitlist control?\n\nResearchers 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.\n\nParticipants will:\n\n* Take part in one-hour weekly visual arts sessions for nine months, led by professional artists;\n* Participate in community art exhibitions at the end of the program;\n* Complete questionnaires on psychological adjustment, self-concept, HRQoL, and societal resource use at baseline and post-intervention;\n* Teachers/technicians will complete questionnaires on children's psychological adjustment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Cognitive deficit, neurological disease or global developmental disorder'}, 'identificationModule': {'nctId': 'NCT07165704', 'briefTitle': 'Community Galleries - Art and Children in Action: Study Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Associação para o Apoio à Integração Social e Comunitária'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ESPACOT1220425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Visual Art Intervention', 'description': "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.", 'interventionNames': ['Other: Visual arts']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control'}], 'interventions': [{'name': 'Visual arts', 'type': 'OTHER', 'otherNames': ['Community Galleries'], 'description': "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.", 'armGroupLabels': ['Visual Art Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000-527', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Associação de Solidariedade da Zona das Fontainhas', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4100-029', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Espaço Raíz', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4100-033', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Escola do Parque Centro de Bem-estar Social Nossa Senhora do Socorro', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4150-193', 'city': 'Porto', 'country': 'Portugal', 'facility': 'A Associação de Promoção Social da População do Bairro do Aleixo', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4250-323', 'city': 'Porto', 'country': 'Portugal', 'facility': 'ASAS (Associação de Solidariedade e Ação Social de Ramalde)', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4300-004', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Paróquia de Nossa Senhora da Ajuda - Pasteleira', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4300-178', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Escola Básica do Falcão', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4300-282', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Centro Social do Lagarteiro', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4350-280', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Escola Básica de Montebello', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4350-297', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Escola Básica de São Roque da Lameira', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'overallOfficials': [{'name': 'Sandra P Henriques, Mastre', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associação Para o Apoio e Integração Social e Comunitária'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Associação para o Apoio à Integração Social e Comunitária', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação Caloust Gulbenkian', 'class': 'UNKNOWN'}, {'name': 'Uppsala University', 'class': 'OTHER'}, {'name': 'Lusofona University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}