Evaluation of Play and Care Together (PACT) Implementation

Resilience Clinical Trial

Official title:

Evaluation of Play & Care Together (PACT) Implementation for Improved Resilience, Life Skills, and Psychosocial Skills Among Participating Children and Peer Supporters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05590975
• Other study ID #: 2022-7690-22673
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Psychosocial Wellbeing
• Resilience

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)