NCT06510478

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 13, 2024

Last Update Submit

July 18, 2024

Conditions

Psychological DistressMental Health IssueQuality of LifeWell-Being, Psychological

Keywords

EfficacyGroup Life Skill InterventionPsychological DistressLife skillsQuality of LifeWell being

Outcome Measures

Primary Outcomes (1)

  • Well Being

    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 Outcomes (2)

  • Life Skills

    2 Months

  • Psychological Distress

    2 Months

Study Arms (3)

Intervention Group

EXPERIMENTAL

Who receives intervention. Life Skill intervention will be administered in 12 sessions.

Behavioral: Group Life Skill Intervention

Control Group

PLACEBO COMPARATOR

Who do not receive any intervention.

Behavioral: Treatment as Usual for Control Group

Waitlist Control Group

ACTIVE COMPARATOR

Who are on the waitlist and will receive intervention components if the intervention is proven to be effective.

Behavioral: Group Life Skill Intervention

Interventions

Group Life Skill InterventionBEHAVIORAL

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.

Intervention GroupWaitlist Control Group
Treatment as Usual for Control GroupBEHAVIORAL

Standard psychological interventions i.e. Debreathing, Meditation, supportive counseling, or psychoeducation.

Control Group

Eligibility Criteria

Age21 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Students of public sector university of Pakistan.
  • Students aged 21-30.
  • Students accessed with decreased psychological well-being.

You may not qualify if:

  • Students of private universities in Pakistan
  • Students with any physical disability.
  • Students having a prior history of psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sahiwal

Sahiwal, Punjab Province, 57000, Pakistan

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

TherapeuticsControl Groups

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Kiran Mushtaq, PhD Scholar

    Fatima Jinnah Women University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Efficacy of Group Life Skill Intervention to enhance Well-Being among Higher Education Students

Study Record Dates

First Submitted

July 13, 2024

First Posted

July 19, 2024

Study Start

February 1, 2024

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Locations

PA(1)