Ignite Creation Date:
2024-05-06 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05072340
Status:
RECRUITING
Last Update Posted:
2023-08-30
First Post:
2021-08-11
Brief Title:
Evaluation of Resilience Skills Enhancement RISE Training Among University Students
Sponsor:
National University of Singapore
Organization:
National University of Singapore
Study Overview
Official Title:
Evaluation of Resilience Skills Enhancement RISE Training Among University Students A Sequential Mixed Methods Study
Status:
RECRUITING
Status Verified Date:
2023-08
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:
Background University students experience high levels of stress and this may negatively impact their mental health coping and academic outcomes Building resilience has been described as an ability to maintain mental well-being
Aims This study aims to 1 assess the feasibility of the Resilience Skills Enhancement RISE program 2 evaluate the effects of RISE on undergraduate students resilience coping emotion regulation positive emotions and stress and 3 explore students perception of RISE
Methods This study will be operationalized in three phases
Phase 1 - Feasibility A single-arm pre-post study will be used 10 students will be recruited to explore their acceptability perception and suggestions for improving RISE RISE comprises of six weekly sessions delivered via LumiNUS and Zoom The Wilcoxon signed rank test will be used to analyse the data
Phase 2 - Randomized controlled trial A prospective double blind randomized controlled trial and repeated post-tests will be used A total of 122 students will be recruited from LumiNUS and social media platforms Participants will receive a series of six weekly online sessions in both groups The primary outcome is resilience The secondary outcomes include coping emotion relation positive emotions stress Multivariate analysis of variance with repeated measures will be used to compare the mean difference of scores in the three time points through Wilkss lambda test The data will be analysed according to the intention-to-treat principle
Phase 3 - Process evaluation A qualitative study using an individual semi-structured interviews will be used to explore students perception of RISE Approximately 20 students will be recruited and the final sample size will be determined based on data saturation Thematic analyses will be used to analyse the data
Potential contributions This study will contribute by evaluating evidence-based user-friendly RISE that may be effective for enhancing university students resilience
Aims This study aims to 1 assess the feasibility of the Resilience Skills Enhancement RISE program 2 evaluate the effects of RISE on undergraduate students resilience coping emotion regulation positive emotions and stress and 3 explore students perception of RISE
Methods This study will be operationalized in three phases
Phase 1 - Feasibility A single-arm pre-post study will be used 10 students will be recruited to explore their acceptability perception and suggestions for improving RISE RISE comprises of six weekly sessions delivered via LumiNUS and Zoom The Wilcoxon signed rank test will be used to analyse the data
Phase 2 - Randomized controlled trial A prospective double blind randomized controlled trial and repeated post-tests will be used A total of 122 students will be recruited from LumiNUS and social media platforms Participants will receive a series of six weekly online sessions in both groups The primary outcome is resilience The secondary outcomes include coping emotion relation positive emotions stress Multivariate analysis of variance with repeated measures will be used to compare the mean difference of scores in the three time points through Wilkss lambda test The data will be analysed according to the intention-to-treat principle
Phase 3 - Process evaluation A qualitative study using an individual semi-structured interviews will be used to explore students perception of RISE Approximately 20 students will be recruited and the final sample size will be determined based on data saturation Thematic analyses will be used to analyse the data
Potential contributions This study will contribute by evaluating evidence-based user-friendly RISE that may be effective for enhancing university students resilience
Detailed Description:
None
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