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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05072340
Other study ID # TEG AY2021/22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 8, 2021
Est. completion date December 31, 2023

Study information

Verified date August 2023
Source National University of Singapore
Contact Ying Lau, PhD
Phone (852)59180547
Email yinglau@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: 1. Full undergraduate in NUS 2. Above 18 years old 3. Comprehend English language 4. Have access to an electronic device (laptop, smartphone or tablet) Exclusion Criteria: 1. No self-reported history of mental health disorders 2. Did not participate in any other form of resilience training

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Hong Kong The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
National University of Singapore

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Baseline
Primary 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). After training complete
Primary 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). Three months after training completes
Secondary 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). Baseline
Secondary 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). After training completes
Secondary 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). Three months after training completes
Secondary 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. Baseline
Secondary 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. After training completes
Secondary 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. Three months after training completes
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