Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06464627 |
| Other study ID # |
10.05.2024 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
August 31, 2023 |
Study information
| Verified date |
June 2024 |
| Source |
KU Leuven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 1,912 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 1,912 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-A≥20) and / or
anxiety (GAD-7≥15) 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.
