- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05072340
Evaluation of Resilience Skills Enhancement (RISE) Training Among University Students
Evaluation of Resilience Skills Enhancement (RISE) Training Among University Students: A Sequential Mixed Methods Study
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 Wilks's 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hong Kong, Hong Kong
- The Chinese University of Hong Kong
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Full undergraduate in NUS
- Above 18 years old
- Comprehend English language
- Have access to an electronic device (laptop, smartphone or tablet)
Exclusion Criteria:
- No self-reported history of mental health disorders
- Did not participate in any other form of resilience training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RISE (Blended learning)
Students will undergo a training that comprises of six sessions: (1) introducing resilience, (2) coping strategies, (3) creating positivity, (4) shifting mindsets, (5) building social competency and (6) preparing for the future. RISE training will be hosted via the NUS' online learning platform, LumiNUS and virtual face-to-face platform, Zoom. Each session will take approximately one to two hours per week. One session is made available each week to encourage completion before moving onto the next session. Students will be provided with materials in the form of interactive videos. Virtual face-to-face sessions, online forum, quizzes and homework will be additionally available to students. |
The RISE training was developed according to theory, empirical evidence and contextual information.
The contents, components, pedagogy, and technical elements of RISE is established based on the resilience theory (Szanton & Gill, 2010) systematic review and meta-analysis, meta-synthesis, and qualitative study (Ang et al., 2021).
Ethical and quality standards was assessed using the Health on the Net code of conduct and the Health-Related Website Evaluation Form respectively.
The overall rating of the designed RISE is more than 75% of the total possible points to ensure quality of website by three research team members.
|
|
Active Comparator: RISE (Asynchronous learning)
Students will also undergo a six-session training comprising of: (1) introducing resilience, (2) coping strategies, (3) creating positivity, (4) shifting mindsets, (5) building social competency and (6) preparing for the future. RISE training will be hosted via the NUS' online learning platform, LumiNUS. One session is made available each week to encourage completion before moving onto the next session. Participants will be reminded via emails and short message service (SMS) to complete the intervention. Students will be provided with materials in the form of interactive videos in LumiNUS. |
The RISE training was developed according to theory, empirical evidence and contextual information.
The contents, components, pedagogy, and technical elements of RISE is established based on the resilience theory (Szanton & Gill, 2010) systematic review and meta-analysis, meta-synthesis, and qualitative study (Ang et al., 2021).
Ethical and quality standards was assessed using the Health on the Net code of conduct and the Health-Related Website Evaluation Form respectively.
The overall rating of the designed RISE is more than 75% of the total possible points to ensure quality of website by three research team members.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resilience
Time Frame: Baseline
|
Resilience will be measured using the 25-item Connor-Davidson Resilience Scale (CD-RISC, Connor & Davidson 2003).
Items are rated on a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all the time), with higher scores indicating higher resilience.
The CD-RISC has good psychometric properties (Windle et al., 2011) and validated among Singapore students (Chue & Cheung, 2021).
|
Baseline
|
|
Resilience
Time Frame: After training complete
|
Resilience will be measured using the 25-item Connor-Davidson Resilience Scale (CD-RISC, Connor & Davidson 2003).
Items are rated on a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all the time), with higher scores indicating higher resilience.
The CD-RISC has good psychometric properties (Windle et al., 2011) and validated among Singapore students (Chue & Cheung, 2021).
|
After training complete
|
|
Resilience
Time Frame: Three months after training completes
|
Resilience will be measured using the 25-item Connor-Davidson Resilience Scale (CD-RISC, Connor & Davidson 2003).
Items are rated on a 5-point Likert scale ranging from 0 (not true at all) to 4 (true nearly all the time), with higher scores indicating higher resilience.
The CD-RISC has good psychometric properties (Windle et al., 2011) and validated among Singapore students (Chue & Cheung, 2021).
|
Three months after training completes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social support
Time Frame: Baseline
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Social support will be measured using the Multidimensional Scale of Perceived Social Support Scale (MSPSS, Zimet et al., 1988).
Items are rated on a 7-point Likert scale ranging from 1 (very strongly disagree) to 7 (very strongly agree), with higher scores indicating better social support.
The MSPSS has good psychometric properties and used among students (Dambi et al., 2018).
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Baseline
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|
Social support
Time Frame: After training completes
|
Social support will be measured using the Multidimensional Scale of Perceived Social Support Scale (MSPSS, Zimet et al., 1988).
Items are rated on a 7-point Likert scale ranging from 1 (very strongly disagree) to 7 (very strongly agree), with higher scores indicating better social support.
The MSPSS has good psychometric properties and used among students (Dambi et al., 2018).
|
After training completes
|
|
Social support
Time Frame: Three months after training completes
|
Social support will be measured using the Multidimensional Scale of Perceived Social Support Scale (MSPSS, Zimet et al., 1988).
Items are rated on a 7-point Likert scale ranging from 1 (very strongly disagree) to 7 (very strongly agree), with higher scores indicating better social support.
The MSPSS has good psychometric properties and used among students (Dambi et al., 2018).
|
Three months after training completes
|
|
Learning
Time Frame: Baseline
|
Students' learning will be measured during the Motivated Strategies for Learning Questionnaire (MSLQ, Pintrich et al., 1991).
The following subscales from MSLQ will be used: (1) Control of learning beliefs, (2) self-efficacy, (3) test anxiety, (4) meta-cognitive self-regulation, (5) time and study environment and (6) effort regulation.
Items are rated on a 7-point Likert scale ranging from 1 (Not true at all of me) to 7 (very true of me), with higher scores indicating better learning strategies.
|
Baseline
|
|
Learning
Time Frame: After training completes
|
Students' learning will be measured during the Motivated Strategies for Learning Questionnaire (MSLQ, Pintrich et al., 1991).
The following subscales from MSLQ will be used: (1) Control of learning beliefs, (2) self-efficacy, (3) test anxiety, (4) meta-cognitive self-regulation, (5) time and study environment and (6) effort regulation.
Items are rated on a 7-point Likert scale ranging from 1 (Not true at all of me) to 7 (very true of me), with higher scores indicating better learning strategies.
|
After training completes
|
|
Learning
Time Frame: Three months after training completes
|
Students' learning will be measured during the Motivated Strategies for Learning Questionnaire (MSLQ, Pintrich et al., 1991).
The following subscales from MSLQ will be used: (1) Control of learning beliefs, (2) self-efficacy, (3) test anxiety, (4) meta-cognitive self-regulation, (5) time and study environment and (6) effort regulation.
Items are rated on a 7-point Likert scale ranging from 1 (Not true at all of me) to 7 (very true of me), with higher scores indicating better learning strategies.
|
Three months after training completes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ying Lau, PhD, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TEG AY2021/22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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