ResilienceNCT05590975
Evaluation of Play and Care Together (PACT) Implementation
A study testing PACT Intervention in people with Resilience and Psychosocial Wellbeing, run by Aga Khan University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Resilience, Psychosocial Wellbeing, Peer Problem
- What is being tested?
- PACT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 9Show fewer
- Children of grade 6 age 12-15 years
- Children who give assent to participate
- Parents who give consent to participate their children
Who cannot join
- Schools who does not give consent to participate
- Children who do not give assent
- Parents who do not give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Resilience, Psychosocial Wellbeing, Peer Problem
- Being tested
- PACT Intervention
- Keywords
- Resilience among children, Life skills, Peer social behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACT InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer Supporter and Adult coach intervention | Experimental | Intervention group will receive PACT module through peer supporters and adult coaches Receives: Behavioral: PACT Intervention |
| Adult coach intervention | Experimental | Intervention group will receive PACT module through adult coaches only Receives: Behavioral: PACT Intervention |
| Control Group | No intervention | Control group will receive PACT intervention after the completion of intervention and evaluation with 1st PACT intervention arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline ( at the time of enrolment), midline (after 5 weeks) and Endline (within two weeks of intervention)
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.
Measured: Baseline ( at the time of enrolment), midline (after 5 weeks) and Endline (within two weeks of intervention)
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.
Measured: Baseline ( at the time of enrolment), midline (after 5 weeks) and Endline (within two weeks of intervention)
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.
Measured: Baseline ( at the time of enrolment), midline (after 5 weeks) and Endline (within two weeks of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Oct 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResilienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The assessment will be carried out parallel in the intervention and the control arm.
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Right to Play
- Responsible party
- Principal investigator, Dr Rozina Karmaliani, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590975
- Sponsor's protocol ID
- 2022-7690-22673
- Status last verified
- Jul 2023
- First submitted
- 4 Oct 2022
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Play & Care Together (PACT) Implementation for Improved Resilience, Life Skills, and Psychosocial Skills Among Participating Children and Peer Supporters
- ClinicalTrials.gov ID
- NCT05590975
- Acronym / sponsor ID
- 2022-7690-22673
- Conditions
- Resilience, Psychosocial Wellbeing, Peer Problem
- Keywords
- Resilience among children, Life skills, Peer social behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Right to Play
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The assessment will be carried out parallel in the intervention and the control arm.
| Arm | Type | Receives |
|---|---|---|
| Peer Supporter and Adult coach intervention | Experimental | Behavioral: PACT InterventionIntervention group will receive PACT module through peer supporters and adult coaches |
| Adult coach intervention | Experimental | Behavioral: PACT InterventionIntervention group will receive PACT module through adult coaches only |
| Control Group | No intervention | –Control group will receive PACT intervention after the completion of intervention and evaluation with 1st PACT intervention arm. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Schools who does not give consent to participate
- Children who do not give assent
- Parents who do not give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACT InterventionPACT 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. | Behavioural | Adult coach intervention, Peer Supporter and Adult coach intervention |
Primary outcome
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACT Intervention in people with Resilience and Psychosocial Wellbeing, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Resilience (time frame: Baseline ( at the time of enrolment), midline (after 5 weeks) and Endline (within two weeks of intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023; AzTrials last refreshed its copy on 1 Nov 2026.