- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05590975
Evaluation of Play and Care Together (PACT) Implementation
Evaluation of Play & Care Together (PACT) Implementation for Improved Resilience, Life Skills, and Psychosocial Skills Among Participating Children and Peer Supporters
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75950
- Aga Khan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer Supporter and Adult coach intervention
Intervention group will receive PACT module through peer supporters and adult coaches
|
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.
|
|
Experimental: Adult coach intervention
Intervention group will receive PACT module through adult coaches only
|
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.
|
|
No Intervention: Control Group
Control group will receive PACT intervention after the completion of intervention and evaluation with 1st PACT intervention arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Resilience
Time Frame: Baseline ( at the time of enrolment), midline (after 5 weeks) and Endline (within two weeks of intervention)
|
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)
|
|
Change in Resilience
Time Frame: Baseline ( at the time of enrolment), midline (after 5 weeks) and Endline (within two weeks of intervention)
|
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)
|
|
Change in social and emotional life skills
Time Frame: Baseline ( at the time of enrolment), midline (after 5 weeks) and Endline (within two weeks of intervention)
|
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)
|
|
Change in Peer social behaviour
Time Frame: Baseline ( at the time of enrolment), midline (after 5 weeks) and Endline (within two weeks of intervention)
|
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)
|
Collaborators and Investigators
Sponsor
Collaborators
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
Other Study ID Numbers
- 2022-7690-22673
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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