- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06510478
Efficacy of Group Life Skill Intervention to Enhance Well-Being Among Higher Education Students
Study Overview
Status
Intervention / Treatment
Detailed Description
The primary aim of this study is to investigate the Efficacy of Group life skills intervention designed to improve the well-being, Life skills, and Quality of life of higher education students. The study also identifies the feasibility of the Life skill intervention in the context of Pakistan. We will also compare these outcomes between two groups: one receiving the intervention and the other not receiving any treatment.
Study Tasks:
Participants, who are University Students aged 21-30 years, were asked to provide informed consent to participate in the study. They completed questionnaires to assess their Life skills, Psychological distress, Well-being, and Quality of life as a pre-assessment.
Participants in the intervention group undergo the Life Skill Intervention, which includes activities like Team building skills, Leadership Skills, Self-respect and appreciation, Effective Communication Skills, Dealing with stress, Positive Thinking, Enhancing confidence, Volunteering, Decision Taking, Problem Solving, Conflict Resolution, Negotiating.
After the intervention, participants completed a post-assessment questionnaires to measure changes in Life skills, Psychological distress, Well-being, and Quality of life.
There will be a control group that does not receive any treatment.
Comparison Group:
Researchers compared the outcomes between the intervention group, who received the Life Skill Intervention and the control group, who did not receive any treatment. This will help us determine if the intervention had a significant impact on Life skills, Psychological distress, Well-being, and Quality of life outcomes for University students.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Sahiwal, Punjab, Pakistan, 57000
- University of Sahiwal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Students of public sector university of Pakistan.
- Students aged 21-30.
- Students accessed with decreased psychological well-being.
Exclusion Criteria:
- Students of private universities in Pakistan
- Students with any physical disability.
- Students having a prior history of psychiatric illness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Who receives intervention.
Life Skill intervention will be administered in 12 sessions.
|
This 13-session life skills program covers essential topics in one-hour sessions.
It starts with introductions and team building, then progresses through leadership, self-esteem, communication, stress management, positive thinking, confidence building, volunteering, decision-making, problem-solving, conflict resolution, and negotiation.
Each session includes ice-breakers, discussions, and targeted exercises.
Each session incorporates ice-breakers, open discussions, and targeted exercises to ensure active learning and skill internalization.
Duration of each session was 1 hour.
|
|
Placebo Comparator: Control Group
Who do not receive any intervention.
|
Standard psychological interventions i.e.
Debreathing, Meditation, supportive counseling, or psychoeducation.
|
|
Active Comparator: Waitlist Control Group
Who are on the waitlist and will receive intervention components if the intervention is proven to be effective.
|
This 13-session life skills program covers essential topics in one-hour sessions.
It starts with introductions and team building, then progresses through leadership, self-esteem, communication, stress management, positive thinking, confidence building, volunteering, decision-making, problem-solving, conflict resolution, and negotiation.
Each session includes ice-breakers, discussions, and targeted exercises.
Each session incorporates ice-breakers, open discussions, and targeted exercises to ensure active learning and skill internalization.
Duration of each session was 1 hour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Well Being
Time Frame: 2 Months
|
14-item scale 'Warwick-Edinburgh Mental Well-being Scale' used to measure.
Minimum score on this scale is 0 and maximum score is 30.Higher score would indicate higher level of well being.
|
2 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Life Skills
Time Frame: 2 Months
|
14-item scale- Life skills questionnaire used to measure.
The minimum score on this scale is 14 and the maximum score is 70.
Scoring higher on this scale indicates higher life skills in individuals.
|
2 Months
|
|
Psychological Distress
Time Frame: 2 Months
|
Depression, Anxiety, and Stress Scale used to measure.
The minimum score on this scale is 0 and the maximum score is 63.
Higher scores on all subscales indicate a higher level of psychological distress.
|
2 Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kiran Mushtaq, PhD Scholar, Fatima Jinnah Women University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FJWU/EC/2023/66
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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