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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05590975
Other study ID # 2022-7690-22673
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date March 30, 2023

Study information

Verified date July 2023
Source Aga Khan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the effectiveness of PACT intervention in improving resilience, life skills, and psychosocial skills among children and peer supporters. The evaluation will be carried out in the Public Schools of Karachi, Sindh, Pakistan.


Description:

Right to Play is a non-governmental organization that offers play-based life skills education in public schools of Pakistan. This project aim to improve psychosocial wellbeing, resilience and social and emotional life skills of students enrolled in secondary schools of Lyari in Karachi South, Sindh, Pakistan through "Play and Act Together (PACT)" curriculum. The Aga Khan University will evaluate effectiveness of their intervention that will be offered in public schools of Karachi. Data will be collected from grade 6 students(children) and grade 7 or 8 peer supporters at baseline, midline and endline of the study. Moreover, throughout PACT intervention, fidelity monitoring would be ensured randomly for 3 sessions out of 10 through a checklist to evaluate accuracy of PACT intervention delivered. Furthermore, feasibility checklist would be filled by each participant at the end of the study to analyze the satisfaction, feasibility of PACT intervention and important learnings from PACT curriculum. After the intervention, focus group discussion will took place to learn about the experiences of children, peer supporters and adult coaches who received PACT intervention.


Recruitment information / eligibility

Status Completed
Enrollment 212
Est. completion date March 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 17 Years
Eligibility Inclusion Criteria: - Have not participated in previous Right to Play activities - Voluntarily agree to participate in this program in 2022-23 - More than 30 students in grades 6 enrolled - A safe playing area (either indoors or outdoors) - Only Boy or Only girl school - Sindh Literacy and Education Department direct administration - Children of grade 6 age 12-15 years - Children who give assent to participate - Parents who give consent to participate their children Exclusion Criteria: - Schools who does not give consent to participate - Children who do not give assent - Parents who do not give consent

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PACT Intervention
PACT Intervention is a group based session delivered by Peer supporters and adult coaches on PACT module. There will be 10 sessions, one per week for 90 to 120 minutes each.

Locations

Country Name City State
Pakistan Aga Khan University Karachi Sindh

Sponsors (2)

Lead Sponsor Collaborator
Aga Khan University Right to Play

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Resilience Tool: Child and Youth Resilience Measure 28: It is a 28 items scale. Point values are assigned to responses; Not at all=1; A little= 2; Somewhat= 3; Quite a bit= 4; A lot= 5. Sum of all items= Higher scores indicate higher levels of characteristics associated with resilience.
Cutoff: Scores below 65 indicate low resilience; between 65 and 81 show moderate resilience; above 81 will be interpreted as high levels of resilience 3 subscales: Individual, relationships with primary care-givers, and contextual factors that facilitate a sense of belonging
Baseline ( at the time of enrolment), midline (after 5 weeks) and Endline (within two weeks of intervention)
Primary Change in Resilience Tool: Resilience Scale 14: This is a 14-item scale in which point values are assigned to responses: strongly disagree=1-4; strongly agree= 5-7.
Validated scale in Pakistan Higher scores indicate higher levels of characteristics associated with resilience.
Its individual resilience scale.
Baseline ( at the time of enrolment), midline (after 5 weeks) and Endline (within two weeks of intervention)
Primary Change in social and emotional life skills Multidimensional Scale of Life Skills in Late Childhood: This is a 19 items scale use to assess the different life skills among children. Point values are assigned to responses; Never=1; Rarely= 2; Sometimes= 3; Very often= 4; Always= 5.
Lower score indicate no skills while higher score indicate good skills.
Baseline ( at the time of enrolment), midline (after 5 weeks) and Endline (within two weeks of intervention)
Primary Change in Peer social behaviour Tool: Strengths and Difficulties Questionnaire: Sub scales (Peer Problem Scale, Prosocial Scale) Score: 0-10 for each subscale Cutoff: Minimum score is positive change while maximum score is negative change. Baseline ( at the time of enrolment), midline (after 5 weeks) and Endline (within two weeks of intervention)
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