Life Skills 101 Feasibility Study

NCT05525897 | Unknown

• 1 other identifier: LEVELUP_Feasibility1
• Study Type: interventional
• Target: 120
• Locations: 4 countries
• Sites: 4

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.

Conditions

Soft Skills

Keywords

Soft skills; transversal skills; life skills; 21st century skills

Outcome Measures

Primary Outcomes (2)

• 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: 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).

  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).

  up to 10 weeks

Secondary Outcomes (9)

• Knowledge

  up to 10 weeks

• Self-Reflection and Insight Scale- Short Form

  up to 10 weeks

• Private Self-Consciousness (PrSC) dimension of Self-Consciousness Scale

  up to 10 weeks

• Single-item self-assessment questions

  up to 10 weeks

• Psychological flexibility

  up to 10 weeks

Study Arms (2)

Life skills course

EXPERIMENTAL

Participants will take part in the psychoeducational course

Other: Psychoeducational

Waitlist

NO INTERVENTION

Interventions

Psychoeducational 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.

Life skills course

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Cyprus: lead
• VU University of Amsterdam: collaborator
• University of Crete: collaborator
• University of Jaén: collaborator

Study Sites (4)

University of Cyprus

Nicosia, 1678, Cyprus

RECRUITING

University of Crete

Rethymno, Greece

NOT YET RECRUITING

Vrije Universiteit Amsterdam

Amsterdam, Netherlands

NOT YET RECRUITING

Universidad de Jaén

Jaén, Spain

NOT YET RECRUITING

Study Officials

• Georgia Panayiotou, PhD

  University of Cyprus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marios Theodorou, PhD

CONTACT

+35722892081; theodorou.marios@ucy.ac.cy

Georgia Panayiotou, PhD

CONTACT

+35722892081; georgiap@ucy.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Georgia Panayiotou, Professor of Clinical Psychology

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: September 2, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: September 30, 2023
• Last Updated: September 2, 2022

Record last verified: 2022-08

Locations

NL (1); CY (1); GR (1); ES (1)