Life Skills 101 Feasibility Study

NCT ID: NCT05525897

Last Updated: 2022-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-09-30

Brief Summary

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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

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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).

Conditions

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Soft Skills

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Life skills course

Participants will take part in the psychoeducational course

Group Type EXPERIMENTAL

Psychoeducational

Intervention Type OTHER

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.

Waitlist

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychoeducational

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- People who are enrolled as students in one of the four universities.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VU University of Amsterdam

OTHER

Sponsor Role collaborator

University of Crete

OTHER

Sponsor Role collaborator

University of Jaén

OTHER

Sponsor Role collaborator

University of Cyprus

OTHER

Sponsor Role lead

Responsible Party

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Prof. Georgia Panayiotou

Dr. Georgia Panayiotou, Professor of Clinical Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgia Panayiotou, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cyprus

Locations

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University of Cyprus

Nicosia, , Cyprus

Site Status RECRUITING

University of Crete

Rethymno, , Greece

Site Status NOT_YET_RECRUITING

Vrije Universiteit Amsterdam

Amsterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Universidad de Jaén

Jaén, , Spain

Site Status NOT_YET_RECRUITING

Countries

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Cyprus Greece Netherlands Spain

Central Contacts

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Marios Theodorou, PhD

Role: CONTACT

+35722892081

Georgia Panayiotou, PhD

Role: CONTACT

+35722892081

Facility Contacts

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Marios o Theodorou, PhD

Role: primary

+35722892081

Georgia Panayiotou, PhD

Role: backup

+35722892081

Panagiota Dimitropoulou, PhD

Role: primary

Alexios Arvanitis, PhD

Role: backup

Elke Vlemincx, PhD

Role: primary

Gabriela Cortez Vazquez

Role: backup

Luis Joaquin Garcia-Lopez, PhD

Role: primary

Manuel Vivas Fernández

Role: backup

Other Identifiers

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LEVELUP_Feasibility1

Identifier Type: -

Identifier Source: org_study_id

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