Resilience, PsychologicalNCT05072340
Evaluation of Resilience Skills Enhancement (RISE) Training Among University Students
A study testing Resilience Skills Enhancement (RISE) in people with Resilience, Psychological and Adaptation, Psychological, run by National University of Singapore at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Resilience, Psychological, Adaptation, Psychological
- What is being tested?
- Resilience Skills Enhancement (RISE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Full undergraduate in NUS
- Above 18 years old
- Comprehend English language
- Have access to an electronic device (laptop, smartphone or tablet)
Who cannot join
- No self-reported history of mental health disorders
- Did not participate in any other form of resilience training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Resilience Skills Enhancement (RISE)
- Keywords
- Resilience training, Blended learning, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience Skills Enhancement (RISE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| RISE (Blended learning) | Experimental | 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. Receives: Behavioral: Resilience Skills Enhancement (RISE) |
| RISE (Asynchronous learning) | Active comparator | 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. Receives: Behavioral: Resilience Skills Enhancement (RISE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience
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).
Measured: Baseline
Resilience
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).
Measured: After training complete
Resilience
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).
Measured: Three months after training completes
Secondary outcomes (6)
Social support
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).
Measured: Baseline
Social support
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).
Measured: After training completes
Social support
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).
Measured: Three months after training completes
Learning
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.
Measured: Baseline
Learning
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.
Measured: After training completes
Learning
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.
Measured: Three months after training completes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start1 Dec 2021
- Primary completion31 Jan 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resilience, PsychologicalStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lau Ying, Chinese University of Hong Kong
- Investigators
- Ying Lau, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072340
- Sponsor's protocol ID
- TEG AY2021/22
- Status last verified
- Dec 2024
- First submitted
- 11 Aug 2021
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Resilience Skills Enhancement (RISE) Training Among University Students: A Sequential Mixed Methods Study
- ClinicalTrials.gov ID
- NCT05072340
- Acronym / sponsor ID
- TEG AY2021/22
- Keywords
- Resilience training, Blended learning, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RISE (Blended learning) | Experimental | Behavioral: Resilience Skills Enhancement (RISE)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. |
| RISE (Asynchronous learning) | Active comparator | Behavioral: Resilience Skills Enhancement (RISE)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Full undergraduate in NUS
- Above 18 years old
- Comprehend English language
- Have access to an electronic device (laptop, smartphone or tablet)
Key exclusion criteria (2 listed)
- No self-reported history of mental health disorders
- Did not participate in any other form of resilience training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilience Skills Enhancement (RISE)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. | Behavioural | RISE (Asynchronous learning), RISE (Blended learning) |
Primary outcome
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).
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).
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).
6 secondary outcomes
Social support
Time frame: Baseline
Social support
Time frame: After training completes
Social support
Time frame: Three months after training completes
Learning
Time frame: Baseline
Learning
Time frame: After training completes
Learning
Time frame: Three months after training completes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Lau, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience Skills Enhancement (RISE) in people with Resilience, Psychological and Adaptation, Psychological, run by National University of Singapore at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.