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:
Associação para o Apoio à Integração Social e Comunitária
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: