Clinical trial NCT05525897: Life Skills 101 Feasibility Study
Official title: A Multi-case Feasibility Study for an Introductory Psychoeducational Course (Life Skills 101) for Students in Higher Education
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Soft Skills
Keywords: Soft skills
transversal skills
life skills
21st century skills
Lead sponsor: University of Cyprus
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
name: University of Crete
name: University of Jaén
First posted: 2022-09-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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 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:

1. Determine feasibility and acceptability of the psychoeducational soft skills intervention.

   1. To estimate feasible recruitment and refusal rates.
   2. To measure key outcome domains such as completion rates, missing data, students-reported measures of social satisfaction.
   3. To determine the acceptability of course resources and factors influencing this.
   4. To measure participants' willingness to participate in highly specialized soft skills training.
2. Estimate effectiveness in terms of changes over time in knowledge, improvement in self-insight and psychological flexibility.
3. Use findings to refine the program and inform the development of a future large-scale randomised control trial (RCT).
4. Explore associated changes in mental health (only RCT pilot).

Eligibility criteria: Inclusion Criteria

- People who are enrolled as students in one of the four universities.

Exclusion criteria

- No specific exclusion criteria.

Primary outcomes:
measure: Feasibility and Acceptability
timeFrame: up to 10 weeks
measure: Self-efficacy
timeFrame: up to 10 weeks
Secondary outcomes:
measure: Knowledge
timeFrame: up to 10 weeks
measure: Self-Reflection and Insight Scale- Short Form
timeFrame: up to 10 weeks
measure: Private Self-Consciousness (PrSC) dimension of Self-Consciousness Scale
timeFrame: up to 10 weeks
measure: Single-item self-assessment questions
timeFrame: up to 10 weeks
measure: Psychological flexibility
timeFrame: up to 10 weeks
measure: Positive mental health
timeFrame: up to 10 weeks
measure: Depression, anxiety and stress
timeFrame: up to 10 weeks
measure: Trait worry
timeFrame: up to 10 weeks
measure: Personal growth mindset
timeFrame: up to 10 weeks
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: University of Cyprus
city: Rethymno
country: Greece
facility: University of Crete
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Amsterdam
city: Jaén
country: Spain
facility: Universidad de Jaén
Study officials:
affiliation: University of Cyprus
name: Georgia Panayiotou, PhD
role: PRINCIPAL_INVESTIGATOR
References: