Mental Health Clinical Trial
— LEVELUP2Official title:
A Multi-case Feasibility Study for "Life Skills Boot Camp": Mastering the Skills for Professional and Personal Success' Training Program
Verified date | March 2023 |
Source | University of Cyprus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In the present study, the investigators aim to examine a) the acceptability and feasibility of the "Life Skills Boot Camp", a series of soft skills trainings for students in higher education. The acceptability and feasibility will be explored from the perspective of stakeholders, including students participating in trainings and trainers who provide them; b) to evaluate potential effectiveness of the training by measuring students' acquired knowledge and improvement on self-insight.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - People who are enrolled as students in one of the four universities. Exclusion Criteria: - No specific exclusion criteria. |
Country | Name | City | State |
---|---|---|---|
Cyprus | University of Cyprus | Nicosia | |
Greece | University of Crete | Rethymno | |
Netherlands | Vrije Universiteit Amsterdam | Amsterdam | |
Spain | Universidad de Jaén | Jaén |
Lead Sponsor | Collaborator |
---|---|
University of Cyprus | University of Crete, University of Jaén, VU University of Amsterdam |
Cyprus, Greece, Netherlands, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of the program | At post-intervention, principal researchers involved in the development and delivery of the intervention in each site, will complete Structured Assessment of FEasibility (SAFE; Bird et al. 2014), a standardised measure of the feasibility of complex interventions (Bird et al. 2014). The SAFE measure comprises 16 items grouped into two sub-scales: Blocks (8 items) and Enablers (8 items). SAFE guidelines recommend that reviewers attend to the individual items of the scale, instead of using summary scores, since items have unequal weight.?he tool has shown excellent interrater reliability (k = 0.84, 95% CI 0.79-0.89) and test-retest reliability (k = 0.89, 95% CI 0.85-0.93). | up to 10 weeks | |
Primary | Acceptability | At post-intervention, all participants will complete a course satisfaction/acceptability questionnaire. The questionnaire will consist of two parts: In part A (quantitative) students will be asked several Likert-scale questions, while part B (qualitative) while contain open-ended response questions relating to their experience, satisfaction, and the challenges/enablers associated with design and implementation of the course. Qualitative data from open-ended questions will be considered alongside the quantitative measures to assess the feasibility of the intervention. The feasibility and acceptability of the intervention will be evaluated, using multiple primary endpoints such as:
Adherence (Total registrations, Attendance Rates, Homework Adherence, Dropouts, App Downloads, App use) Acceptability (Course acceptability, course satisfaction, perceptions measured by both Likert Scale Questionnaire and open-ended questions). |
up to 10 weeks | |
Primary | Instructors' perspectives | A brief post-questionnaire consisted of open-ended questions will explore instructors' experiences in terms of delivery of learning content and practical challenges faced during trainings. | up to 10 weeks | |
Secondary | Emotion regulation skills | Difficulties with Emotion regulation Scale (DERS-18; Victor, & Klonsky, 2016) consists of 18-items on a 5- point Likert scale (1 'never' to 5 'almost always') measuring emotion regulation problems. It measures six subscales: (1) Nonacceptance of emotional responses; (2) difficulty engaging in goal-directed behavior, (3) impulse control difficulties; (4) lack of emotional awareness, (5) limited access to emotion regulation strategies; and (6) lack of emotional clarity. Total internal reliability is excellent: Cronbach's a = .91; subscales internal consistency is good to excellent: Cronbach's a = .77 to .9. | up to 10 weeks | |
Secondary | Coping and resilience skills | The Connor-Davidson Resilience Scale (CD-RISC-10; Connor, & Davidson, 2003) measures resilience on a 5-point Liker scale (1 'not true at all'to 5 'true nearly all the time'). Internal consistency is good (Cronbach's a = .87). | up to 10 weeks | |
Secondary | Perceived stress | Perceived stress scale (PSS-10; Cohen, Kamarck, & Mermelstein, 1983) consists of 10-items measuring stress levels on a 4- point Likert scale (0 'never' to 4 'very often'). Internal consistency is good (Cronbach's a = .84 to .86) | up to 10 weeks | |
Secondary | Interpersonal skills | Interpersonal Competence Questionnaire (brief form - ICQ-15; Coroiu, et al. 2014) consists of 1-items on a 5-point Liker scale (1 'I am always poor at this to 5 'I am expremely good at this) measuring interpersonal skills. It measures: (1) initiation; (2) Negative assertion; (3) Emotional support; (4) Disclosure; and (5) conflict management. Internal consistency is good (Cronbach's a = .87). | up to 10 weeks | |
Secondary | Positive mental health | Mental health Continuum-Short Form (MHC-SF; Keyes, 2006) consists of 14-items on a 6- point Likert scale (0 'never' to 5 'everyday'). It measures (1) emotional wellbeing (happiness, interest, satisfaction); (2) psychological wellbeing (selfacceptance, mastery, positive relations, personal growth, autonomy, purpose in life), and (3) social wellbeing (social contribution, integration, actualization, acceptance, coherence). Higher scores indicate greater levels of positive wellbeing.
The instrument has shown good internal reliability for the total score (Cronbach's a = .89) and acceptable to good internal consistency for its subscales (Cronbach's a = .74 to 83). |
up to 10 weeks | |
Secondary | Depression, anxiety and stress | Depression Anxiety Stress Scales (DASS-21;Henry, & Crawford, 2005) consist of three scales (7 items per scale) measuring states of depression, anxiety and stress on a 4 point Likert scale (0 'almost always' to 4 'never'). higher scores indicating a greater number of symptoms. The DASS-21 subscales show good internal consistency (Cronbach's a = 0.81- 0.88). | up to 10 weeks |
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