NCT05590975

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

October 4, 2022

Last Update Submit

July 7, 2023

Conditions

Keywords

Resilience among childrenLife skillsPeer social behavior

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (3)

Peer Supporter and Adult coach intervention

EXPERIMENTAL

Intervention group will receive PACT module through peer supporters and adult coaches

Behavioral: PACT Intervention

Adult coach intervention

EXPERIMENTAL

Intervention group will receive PACT module through adult coaches only

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.

Interventions

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.

Adult coach interventionPeer Supporter and Adult coach intervention

Eligibility Criteria

Age8 Years - 17 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsGrade 6 children Grade 7 and 8 Peer supporters
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Schools who does not give consent to participate
  • Children who do not give assent
  • Parents who do not give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 75950, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The assessment will be carried out parallel in the intervention and the control arm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Dean

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 21, 2022

Study Start

October 1, 2022

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Locations