Viewing Study NCT05376007



Ignite Creation Date: 2024-05-06 @ 5:37 PM
Last Modification Date: 2024-10-26 @ 2:32 PM
Study NCT ID: NCT05376007
Status: COMPLETED
Last Update Posted: 2024-05-14
First Post: 2022-04-21

Brief Title: Effectiveness of the Serious Game Broodles for Siblings of Children With Visual Impairment andor Intellectual Disability
Sponsor: VU University of Amsterdam
Organization: VU University of Amsterdam

Study Overview

Official Title: The Effectiveness of the Serious Game Broodles in Improving Psychosocial Well-being of Siblings 6-9 Years Old of Children With Visual Impairment andor Intellectual Disability A Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2024-05
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 support for siblings of children with disabilities is scarce and fragmented even though studies have shown that these siblings can benefit from support Although some interventions for siblings have been developed these are costly and time-consuming and the effects have not been researched thoroughly with randomized controlled trials This study will investigate the effectiveness of the newly developed serious game Broodles in improving the quality of life and psychosocial well-being of healthy siblings aged 6-9 years of children with intellectual disability ID andor visual impairment VI The effectiveness of the serious game will be examined in a randomized controlled trial RCT with a pre-test T0 post-test T1 and follow-up T2 There will be two groups namely an experimental group playing the serious game and a waitlist control group Quantitative and qualitative measures will be used including questionnaires drawings and open-ended questions Both the sibling and one parent will complete the assessments

The serious game named Broodles is a psychological intervention that addresses how to handle thoughts and emotions concerning several important issues in the lives of siblings The game has 8 levels that take approximately 20 minutes to play In addition to the serious game children make offline worksheets and parents receive tips and information on how to support their child The primary study parameters are quality of life and sibling adjustment to and perceptions of the disability of the brother or sister Secondary study parameters are different aspects of psychosocial well-being including self-esteem experienced social support sibling relationship coping skills parent-child relationship and social validity It is expected that the participants in the experimental conditions will benefit from playing the game namely their quality of life and psychosocial well-being is expected to improve
Detailed Description: A detailed description can be found in the published protocol in Trials

Study Oversight

Has Oversight DMC: None
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?: None
Secondary IDs
Secondary ID Type Domain Link
NL7985202922 REGISTRY CCMO None