Evaluation of Right To Play's Positive Child and Youth Development Program in Middle Schools in Hyderabad, Pakistan
Primary Purpose
Peer Violence, Depression
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Right To Play's Positive Child and Youth Development program
Sponsored by

About this trial
This is an interventional prevention trial for Peer Violence
Eligibility Criteria
Inclusion Criteria:
- Schools: single sex, public middle schools in Hyderabad; willing to participate and commit time during the school day, twice a week, to the intervention sessions; having an outside playground or indoor space in which games could be played, and 35 or more students in the grade-6 class
School student participants: enrolled in grade 6 in one of the study schools; informed consent from parent and child; able to read the national language Urdu or provincial language Sindhi
Exclusion Criteria:
- None
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Right To Play's Positive Child and Youth Development program
Control
Arm Description
Behavioural intervention
No intervention; intervention to be offered after end line assessment
Outcomes
Primary Outcome Measures
Peer violence victimisation in the past 4 weeks
Mean score on the sixteen questions on peer violence victimisation
Peer violence perpetration in the past 4 weeks
Mean score on the sixteen questions on peer violence perpetration
Depression
Score on the 28 items Children's Depression Inventory 2 (CDI 2)
Secondary Outcome Measures
School performance
Mean score on four items asking about performance in reading, writing, maths and Pakistan studies . Responses per item are 1=fail, 2=average, 3=excellent
Days of school missed in last 4 weeks
Mean
preparations for marriage
Based on two questions "have you been promised for marriage' and (if so) 'has your family started other preparation for your marriage?' An affirmative response to the latter will be compared to a negative response combined with the category of students who have not been promised in marriage.
Corporal punishment in the past 4 weeks
Mean score across the 6 questions
Physical punishment at home in past 4 weeks
Based on two items with four response categories. The mean score will be calculated.
Gender attitudes (13 items measuring acceptability of spousal violence, girls schooling, male respect for women in decision-making and appropriateness of women's participation)
Mean score
Full Information
NCT ID
NCT03448523
First Posted
February 22, 2018
Last Updated
February 28, 2018
Sponsor
Medical Research Council, South Africa
Collaborators
Aga Khan University, Texas Woman's University
1. Study Identification
Unique Protocol Identification Number
NCT03448523
Brief Title
Evaluation of Right To Play's Positive Child and Youth Development Program in Middle Schools in Hyderabad, Pakistan
Official Title
Evaluation of Right To Play's Positive Child and Youth Development Program: A Cluster Randomised Controlled Trial of a School Play-based Intervention to Prevent Peer Violence and Depression in Hyderabad, Pakistan
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
March 9, 2018 (Anticipated)
Study Completion Date
August 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Research Council, South Africa
Collaborators
Aga Khan University, Texas Woman's University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a RCT conducted with 1752 children in 40 public middle schools in Hyderabad Pakistan with the goal of evaluating the effectiveness of the international non-governmental organisation Right To Play's Positive Child and Youth Development program on reducing peer violence perpetration and victimisation and child depression in a two arm trial where this intervention is compared to a no intervention arm.
Detailed Description
Peer violence is an important violence exposure for young adolescents and has been linked to later perpetration or experience of violence in intimate relationships. It is an obstacle to learning and may impact school students' mental health. Prevention of peer violence requires an intervention that empowers youth and teaches them empathy and stronger social skills. The non-governmental organisation Right To Play operates in 18 countries and has a flagship programme that is used in all countries that has never been subject to most rigorous evaluation. It is a multi-faceted programme that has at its heart an intervention that is delivered throughout the school year in two 35 minute sessions games following activities from the manual Red Ball Child Play that focus on 4 areas of youth development: physical, cognitive, social, and emotional components. These structural activities are designed to improve critical thinking, confidence and resilience. They are complimented by a range of additional activities including junior leader training for selected promising young leaders, week long summary camps, sports days and activities to engage parents and members of the community. The main intervention is delivered by coaches employed by Right To Play and given a 3 week training initially, with subsequent regular refresher engagement. They are supported by junior leaders in the games after junior leader training. Training to teachers on the intervention is also provided.
A two-arm, cluster randomised controlled trial based in middle schools in Hyderabad, Sindh province, Pakistan is evaluating this intervention. It is being conducted in 40 schools, half are boys schools (20) and half (20) girls'. Twenty of the schools have been randomised to the intervention arm and twenty to the control (delayed intervention) arm. The outcomes will be addressed using quantitative methods with data collected from students in Grade 6 at the start of the trial. These measures will be conducted pre-intervention and 12, and 24 month follow up periods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peer Violence, Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
open label, randomised, efficacy study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1752 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Right To Play's Positive Child and Youth Development program
Arm Type
Experimental
Arm Description
Behavioural intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention; intervention to be offered after end line assessment
Intervention Type
Behavioral
Intervention Name(s)
Right To Play's Positive Child and Youth Development program
Intervention Description
Right To Play's Red Ball Child Play manual provided for 60 hours per annum for two years
Training of junior leaders
Related play-based activities such as sports days
Quarterly awareness sessions with community groups and parents
Summer camps for children
training of teachers on Right To Play's foundational resources, positive disciplining, and gender and child protection
Primary Outcome Measure Information:
Title
Peer violence victimisation in the past 4 weeks
Description
Mean score on the sixteen questions on peer violence victimisation
Time Frame
assessment 2 years post-baseline
Title
Peer violence perpetration in the past 4 weeks
Description
Mean score on the sixteen questions on peer violence perpetration
Time Frame
assessment 2 years post-baseline
Title
Depression
Description
Score on the 28 items Children's Depression Inventory 2 (CDI 2)
Time Frame
Over last 2 weeks
Secondary Outcome Measure Information:
Title
School performance
Description
Mean score on four items asking about performance in reading, writing, maths and Pakistan studies . Responses per item are 1=fail, 2=average, 3=excellent
Time Frame
2 years post baseline
Title
Days of school missed in last 4 weeks
Description
Mean
Time Frame
2 years post-baseline
Title
preparations for marriage
Description
Based on two questions "have you been promised for marriage' and (if so) 'has your family started other preparation for your marriage?' An affirmative response to the latter will be compared to a negative response combined with the category of students who have not been promised in marriage.
Time Frame
2 years post baseline
Title
Corporal punishment in the past 4 weeks
Description
Mean score across the 6 questions
Time Frame
2 years post baseline
Title
Physical punishment at home in past 4 weeks
Description
Based on two items with four response categories. The mean score will be calculated.
Time Frame
2 years post baseline
Title
Gender attitudes (13 items measuring acceptability of spousal violence, girls schooling, male respect for women in decision-making and appropriateness of women's participation)
Description
Mean score
Time Frame
2 years post baseline
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Schools: single sex, public middle schools in Hyderabad; willing to participate and commit time during the school day, twice a week, to the intervention sessions; having an outside playground or indoor space in which games could be played, and 35 or more students in the grade-6 class
School student participants: enrolled in grade 6 in one of the study schools; informed consent from parent and child; able to read the national language Urdu or provincial language Sindhi
Exclusion Criteria:
None
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data will me made available open access but it will not be individual participant data. The details are still being worked out
Learn more about this trial
Evaluation of Right To Play's Positive Child and Youth Development Program in Middle Schools in Hyderabad, Pakistan
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