Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464627
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
Physical Activity Reduces Anxiety and Depression in Youth Affected by Displacement a Randomized Controlled Trial of the Game Connect Program in Uganda
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
Official Title:
Physical Activity Reduces Anxiety and Depression in Youth Affected by Displacement a Randomized Controlled Trial of the Game Connect Program in Uganda
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Game Connect
Brief Summary:
This randomized controlled trial investigated 12 weeks of physical activity or to 12 weeks in a waiting control condition in youth aged 15 to 24 years old affected by displacement
Detailed Description:
In 2020 the Olympic Refuge Foundation ORF initiated Game Connect a sport-for-protection project in Uganda The current study lasted from September 2022 to August 2023 The project was executed by a consortium led by non-governmental organizations including AVSI Foundation Right to Play Youth Sport Uganda the Uganda Olympic Committee and the United Nations High Commissioner for Refugees Included districts were Kampala Rwamwanja Palabek Adjumani and Kyangwali as they host the largest refugee settlements Also the surrounding host communities were included A total of 1912 potential villages that could be targeted were identified some of which were grouped in clusters The decision to cluster villages was influenced by factors such as the limited number of young people in some villages and proximity of households to each other despite living in different villages In total 869 villages out of the 1912 were at random selected for inclusion in the program Block randomization was applied to ensure equal representation across the targeted districts Following selection of the villages all youth in selected villages were identified Eligible participants in the selected 869 villages of the five catchment areas were a young displaced or host-community adolescents and young adults aged 15 to 24 years and b at least mild symptoms of anxiety and or depression defined as a Patient Health Questionnaire -9 adolescent version PHQ-9-A Spitzer et al 1999 and or the Generalized Anxiety Disorder-7 GAD-7 Spitzer et al 2006 score of 5 or higher Those with severe depression PHQ-9-A20 and or anxiety GAD-715 were eligible to participate but additionally referred to local services for specialized support Eligible young people were at random allocated to either 12 weeks of physical activity or to 12 weeks in a waiting control condition All participants completed at baseline and immediately post-intervention the interviewer-administered PHQ-9-A Spitzer et al 1999 and GAD-7 Spitzer et al 2006 An independent team of well-trained research assistants performed the interviews to minimize potential bias The research assistants were recruited locally from refugee settlements and surrounding host communities Data collection tools were pretested to ensure coherence and understandability of questions before the actual data collection commenced Ethical approval was obtained from the Makerere University School of Social Sciences Research Ethics Committee and the Uganda National Council for Science and Technology Informed written assent was obtained from all participants Consent was secured from the current caregivers of youths aged 15-17 years
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