Evaluation of Play and Care Together (PACT) Implementation

July 7, 2023 updated by: Dr Rozina Karmaliani, Aga Khan University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75950
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Peer Supporter and Adult coach intervention
Intervention group will receive PACT module through peer supporters and adult coaches
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.
Experimental: Adult coach intervention
Intervention group will receive PACT module through adult coaches only
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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aga Khan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Right to Play

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-7690-22673

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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