Soft SkillsLEVELUP1NCT05525897
Life Skills 101 Feasibility Study
A study testing Psychoeducational in people with Soft Skills, run by University of Cyprus at 4 sites in 4 countries.
Trial summary
In the present study, the investigators aim to examine the feasibility of embedding a classroom-based soft skills intervention within a tertiary curriculum. The primary objective of this study is to assess the acceptability and feasibility of the "Life Skills 101", a novel psychoeducational course for students in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Soft Skills
- What is being tested?
- Psychoeducational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 1 Jul 2022to 30 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People who are enrolled as students in one of the four universities.
Who cannot join
- No specific exclusion criteria.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Cyprus1 site, 1 recruiting
- Recruiting
University of Cyprus
Nicosia, 1678
Marios o Theodorou, PhD, +35722892081, theodorou.marios@ucy.ac.cy
Georgia Panayiotou, PhD, +35722892081, georgiap@ucy.ac.cy
Greece1 site, 1 recruiting
- Not yet recruiting
University of Crete
Rethymno
Panagiota Dimitropoulou, PhD, p.dimitropoulou@uoc.gr
Alexios Arvanitis, PhD, a.arvanitis@uoc.gr
Netherlands1 site, 1 recruiting
- Not yet recruiting
Vrije Universiteit Amsterdam
Amsterdam
Elke Vlemincx, PhD, e.vlemincx@vu.nl
Gabriela Cortez Vazquez, g.g.cortezvazquez@vu.nl
Spain1 site, 1 recruiting
- Not yet recruiting
Universidad de Jaén
Jaén
Luis Joaquin Garcia-Lopez, PhD, ljgarlo@cop.es
Manuel Vivas Fernández, manuel.vivasfernandez@gmail.com
About this study
Official title: A Multi-case Feasibility Study for an Introductory Psychoeducational Course (Life Skills 101) for Students in Higher Education
In the present study, the investigators aim to examine the feasibility of embedding a classroom-based soft skills intervention within a tertiary curriculum.
The primary objective of this study is to assess the acceptability and feasibility of the "Life Skills 101", a novel psychoeducational course for students in higher education.
Read more
The secondary objective of this study is to evaluate potential effectiveness of the course by measuring students' acquired knowledge and improvement on self-insight.
Different methodologies will be used as part of the stage model for behavioral intervention development. In specific, three universities (CY, GR, SP) will run a single-arm study, while the fourth university (NL) will run an RCT pilot study.
Read the detailed description
Background/Rationale The role of Higher Education in sustained economic growth, and social progress is critical. HE institutions (HEIs) as key 'future shaper' settings, host a significant proportion of talented youth, future workforce, and leaders. Entering university marks a turning point for youth, since HEIs can empower young people to transform and expand skills to manage complex and global environmental and societal challenges.
Soft skills, such as the ability to set goals and achieve them, to regulate emotions, to demonstrate agility and adaptability, and manage interpersonal relationships, are now an emerging trend for tackling global economic and societal challenges. Despite soft skills importance, evidence confirms a "skills gap", meaning that youth lack soft skills that are highly important in the workplace. In addition, soft skills related to mental and physical health, wellbeing and adjustment, have received growing interest over recent years, and have become even more critical in the context of emerging needs to build resilience in the face of the Covid-19 pandemic and in preparation for future crises.
Given these challenges to individuals' academic performance, work achievement, mental health, it would be advisable to equip students with the resources required for life success. As these skills become increasingly of central interest to communities, it becomes a pertinent question on how to expand them within the academic context by learning relevant information and practicing skills in a way that is responsive to the needs of the wider student community. A key priority for HEIs is to promote a comprehensive approach to education, by putting students' transversal skills on an equal footing with profession-specific knowledge and skills. One efficient way to address this, in a way that can reach as many interested students as possible, is through incorporating the necessary material in existing, popular and frequently offered elective or mandatory courses, in which training these skills is suitable.
In the present study, the investigators aim to examine the feasibility of embedding a classroom-based soft skills intervention within a tertiary curriculum. This course covers cutting-edge research on how people acquire self-regulatory skills enabling them to achieve personal, academic, and professional goals. Students will learn through instruction and experiential methods, how these discoveries relate to needs, cognitions, emotions, and behaviors, and what tools can be used to achieve their goals.
Study aims/Objectives
The primary objective of this study is to assess the acceptability and feasibility of the "Life Skills 101", a novel psychoeducational course for students in higher education. The secondary objective of this study is to evaluate potential effectiveness of the course by measuring students' acquired knowledge and improvement on self-insight. The specific objectives of the study are to:
- Determine feasibility and acceptability of the psychoeducational soft skills intervention.
- To estimate feasible recruitment and refusal rates.
- To measure key outcome domains such as completion rates, missing data, students-reported measures of social satisfaction.
- To determine the acceptability of course resources and factors influencing this.
- To measure participants' willingness to participate in highly specialized soft skills training.
- Estimate effectiveness in terms of changes over time in knowledge, improvement in self-insight and psychological flexibility.
- Use findings to refine the program and inform the development of a future large-scale randomised control trial (RCT).
- Explore associated changes in mental health (only RCT pilot).
- Conditions
- Soft Skills
- Being tested
- Psychoeducational
- Keywords
- Soft skills, transversal skills, life skills, 21st century skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationalOther
The focus of the course is to teach students the fundamental theories, and practices of soft skills, as well as providing cases and material that give students the opportunity to learn from real life experiences.
| Study group | Role | What they receive |
|---|---|---|
| Life skills course | Experimental | Participants will take part in the psychoeducational course Receives: Other: Psychoeducational |
| Waitlist | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and 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).
Measured: up to 10 weeks
Self-efficacy
The General self-efficacy scale (GSE) consists of 10-items on a 4-point Likert scale (1 'not at all true' to 4 'exactly true'). A total score, on a scale of 10 to 40 can be calculated. Higher scores indicate higher perceived general self-efficacy. Its internal consistency is good (Cronbach α = .85).
Measured: up to 10 weeks
Secondary outcomes (9)
Knowledge
The research team will develop a 10-item multiple choice quiz to assess students' knowledge on fundamental concepts of the course content.
Measured: up to 10 weeks
Self-Reflection and Insight Scale- Short Form
Self-Reflection and Insight Scale- Short Form (SRIS-SF) to assess students' changes in the clarity of understanding their thoughts, feelings and behavior (Self-Reflection Cronbach's α = .87 and Insight Scale Cronbach's α = .83). Higher total score mean more perceived levels of self-awareness.
Measured: up to 10 weeks
Private Self-Consciousness (PrSC) dimension of Self-Consciousness Scale
Private Self-Consciousness (PrSC) dimension of Self-Consciousness Scale (SCS; Cronbach's α = .79), measures internal state awareness, the tendency to cover aspects of self, such as values, beliefs, feelings etc. Higher score refers to higher levels of self-consciousness.
Measured: up to 10 weeks
Single-item self-assessment questions
Single-item self-assessment questions (about students' perceived competency on the skill taught) will be filled (pre-post session) via a digital learning tool (app). The question will be posed as follows: "Imagine a ladder (see picture), which represents how competent a person is according to a skill. The top of the ladder reflects the mastery of skill, while the bottom reflects significant deficiencies in that skill. At what point on the ladder would you place yourself in Self-regulation skills? Choose the number that best represents you where you place yourself: 1-10".
Measured: up to 10 weeks
Psychological flexibility
The Acceptance and Action Questionnaire-II is a 7-item measure of psychological flexibility rated on a 7-point scale (Cronbach's α = 0.84). It assesses the ability to be fully present in the moment and adjusting behaviors based on the situational demands, personal values and goals. Higher total score mean less flexibility.
Measured: up to 10 weeks
Positive mental health
Mental health Continuum-Short Form (MHC-SF) 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 (self-acceptance, 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 well-being. The instrument has shown good internal reliability for the total score (Cronbach's α = .89) and acceptable to good internal consistency for its subscales (Cronbach's α = .74 to 83).
Measured: up to 10 weeks
Depression, anxiety and stress
Depression Anxiety Stress Scales (DASS-21) 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 α = 0.81- 0.88).
Measured: up to 10 weeks
Trait worry
Penn state Worry Questionnaire (PSWQ) is a self-report questionnaire measuring frequent negative thoughts. The scale has 14 items and have to be scored on a 4 point scale with 0=not true and 4=very true. Higher scores are indicative of higher levels of trait worry. The instrument shows excellent internal consistency (Cronbach α = .91).
Measured: up to 10 weeks
Personal growth mindset
The Personal Growth Initiative Scale - II © (PGIS-II) measures the active and intentional involvement in personal change and development in terms of readiness to change, planfulness, using resources, and intentional behavior. Higher scores are indicative of greater Personal Growth Initiative. The instrument's internal consistency is excellent (Cronbach's α = .90 to .94).
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Jul 2022
- Primary completionJul 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft SkillsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will use a pre-post design with a multi-case study approach to evaluate the feasibility and implementation of the psycho-educational intervention in four university settings. In specific, three universities (CY, GR, SP) will run a single-arm study, while the fourth university (NL) will run an RCT pilot study (see RCT pilot study methods for details). A mixed-methods design will be used to determine the feasibility and acceptability of a novel soft-skills psychoeducational course.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cyprus
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam, University of Crete, University of Jaén
- Responsible party
- Principal investigator, Prof. Georgia Panayiotou, University of Cyprus
- Investigators
- Georgia Panayiotou, PhD, Principal investigator, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525897
- Sponsor's protocol ID
- LEVELUP_Feasibility1
- Acronym
- LEVELUP1
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-case Feasibility Study for an Introductory Psychoeducational Course (Life Skills 101) for Students in Higher Education
- ClinicalTrials.gov ID
- NCT05525897
- Acronym / sponsor ID
- LEVELUP1 / LEVELUP_Feasibility1
- Conditions
- Soft Skills
- Keywords
- Soft skills, transversal skills, life skills, 21st century skills
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Collaborators
- VU University of Amsterdam, University of Crete, University of Jaén
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 2 Sep 2022 (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.
In the present study, the investigators aim to examine the feasibility of embedding a classroom-based soft skills intervention within a tertiary curriculum.
The primary objective of this study is to assess the acceptability and feasibility of the "Life Skills 101", a novel psychoeducational course for students in higher education.
The secondary objective of this study is to evaluate potential effectiveness of the course by measuring students' acquired knowledge and improvement on self-insight.
Different methodologies will be used as part of the stage model for behavioral intervention development. In specific, three universities (CY, GR, SP) will run a single-arm study, while the fourth university (NL) will run an RCT pilot study.
Detailed description
Background/Rationale The role of Higher Education in sustained economic growth, and social progress is critical. HE institutions (HEIs) as key 'future shaper' settings, host a significant proportion of talented youth, future workforce, and leaders. Entering university marks a turning point for youth, since HEIs can empower young people to transform and expand skills to manage complex and global environmental and societal challenges.
Soft skills, such as the ability to set goals and achieve them, to regulate emotions, to demonstrate agility and adaptability, and manage interpersonal relationships, are now an emerging trend for tackling global economic and societal challenges. Despite soft skills importance, evidence confirms a "skills gap", meaning that youth lack soft skills that are highly important in the workplace. In addition, soft skills related to mental and physical health, wellbeing and adjustment, have received growing interest over recent years, and have become even more critical in the context of emerging needs to build resilience in the face of the Covid-19 pandemic and in preparation for future crises.
Given these challenges to individuals' academic performance, work achievement, mental health, it would be advisable to equip students with the resources required for life success. As these skills become increasingly of central interest to communities, it becomes a pertinent question on how to expand them within the academic context by learning relevant information and practicing skills in a way that is responsive to the needs of the wider student community. A key priority for HEIs is to promote a comprehensive approach to education, by putting students' transversal skills on an equal footing with profession-specific knowledge and skills. One efficient way to address this, in a way that can reach as many interested students as possible, is through incorporating the necessary material in existing, popular and frequently offered elective or mandatory courses, in which training these skills is suitable.
In the present study, the investigators aim to examine the feasibility of embedding a classroom-based soft skills intervention within a tertiary curriculum. This course covers cutting-edge research on how people acquire self-regulatory skills enabling them to achieve personal, academic, and professional goals. Students will learn through instruction and experiential methods, how these discoveries relate to needs, cognitions, emotions, and behaviors, and what tools can be used to achieve their goals.
Study aims/Objectives
The primary objective of this study is to assess the acceptability and feasibility of the "Life Skills 101", a novel psychoeducational course for students in higher education. The secondary objective of this study is to evaluate potential effectiveness of the course by measuring students' acquired knowledge and improvement on self-insight. The specific objectives of the study are to:
- Determine feasibility and acceptability of the psychoeducational soft skills intervention.
- To estimate feasible recruitment and refusal rates.
- To measure key outcome domains such as completion rates, missing data, students-reported measures of social satisfaction.
- To determine the acceptability of course resources and factors influencing this.
- To measure participants' willingness to participate in highly specialized soft skills training.
- Estimate effectiveness in terms of changes over time in knowledge, improvement in self-insight and psychological flexibility.
- Use findings to refine the program and inform the development of a future large-scale randomised control trial (RCT).
- Explore associated changes in mental health (only RCT pilot).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will use a pre-post design with a multi-case study approach to evaluate the feasibility and implementation of the psycho-educational intervention in four university settings. In specific, three universities (CY, GR, SP) will run a single-arm study, while the fourth university (NL) will run an RCT pilot study (see RCT pilot study methods for details). A mixed-methods design will be used to determine the feasibility and acceptability of a novel soft-skills psychoeducational course.
| Arm | Type | Receives |
|---|---|---|
| Life skills course | Experimental | Other: PsychoeducationalParticipants will take part in the psychoeducational course |
| Waitlist | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People who are enrolled as students in one of the four universities.
Key exclusion criteria (1 listed)
- No specific exclusion criteria.
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 |
|---|---|---|
| PsychoeducationalThe focus of the course is to teach students the fundamental theories, and practices of soft skills, as well as providing cases and material that give students the opportunity to learn from real life experiences. | Other | Life skills course |
Primary outcome
Feasibility and Acceptability
Time frame: up to 10 weeks
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: 1. Adherence (Total registrations, Attendance Rates, Homework Adherence, Dropouts, App Downloads, App use) 2. Acceptability (Course acceptability, course satisfaction, perceptions measured by both Likert Scale Questionnaire and open-ended questions).
Self-efficacy
Time frame: up to 10 weeks
The General self-efficacy scale (GSE) consists of 10-items on a 4-point Likert scale (1 'not at all true' to 4 'exactly true'). A total score, on a scale of 10 to 40 can be calculated. Higher scores indicate higher perceived general self-efficacy. Its internal consistency is good (Cronbach α = .85).
9 secondary outcomes
Knowledge
Time frame: up to 10 weeks
Self-Reflection and Insight Scale- Short Form
Time frame: up to 10 weeks
Private Self-Consciousness (PrSC) dimension of Self-Consciousness Scale
Time frame: up to 10 weeks
Single-item self-assessment questions
Time frame: up to 10 weeks
Psychological flexibility
Time frame: up to 10 weeks
Positive mental health
Time frame: up to 10 weeks
Depression, anxiety and stress
Time frame: up to 10 weeks
Trait worry
Time frame: up to 10 weeks
Personal growth mindset
Time frame: up to 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Soft Skills
Recruiting
Internet Assisted Career-Oriented Soft-skills Training for Transition Age Youth with Mental Health Conditions
Mental Health Wellness 1, Mental Health Wellness 2
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.
Georgia Panayiotou, PhD principal investigator
University of Cyprus
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational in people with Soft Skills, run by University of Cyprus at 4 sites in 4 countries.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Cyprus, Greece, Netherlands, Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marios Theodorou, PhD (+35722892081, theodorou.marios@ucy.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability (time frame: up to 10 weeks). The study lists 2 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 2 Sep 2022.