- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03448523
Evaluation of Right To Play's Positive Child and Youth Development Program in Middle Schools in Hyderabad, Pakistan
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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: Right To Play's Positive Child and Youth Development program
Behavioural intervention
|
|
No Intervention: Control
No intervention; intervention to be offered after end line assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peer violence victimisation in the past 4 weeks
Time Frame: assessment 2 years post-baseline
|
Mean score on the sixteen questions on peer violence victimisation
|
assessment 2 years post-baseline
|
Peer violence perpetration in the past 4 weeks
Time Frame: assessment 2 years post-baseline
|
Mean score on the sixteen questions on peer violence perpetration
|
assessment 2 years post-baseline
|
Depression
Time Frame: Over last 2 weeks
|
Score on the 28 items Children's Depression Inventory 2 (CDI 2)
|
Over last 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
School performance
Time Frame: 2 years post baseline
|
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
|
2 years post baseline
|
Days of school missed in last 4 weeks
Time Frame: 2 years post-baseline
|
Mean
|
2 years post-baseline
|
preparations for marriage
Time Frame: 2 years post baseline
|
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.
|
2 years post baseline
|
Corporal punishment in the past 4 weeks
Time Frame: 2 years post baseline
|
Mean score across the 6 questions
|
2 years post baseline
|
Physical punishment at home in past 4 weeks
Time Frame: 2 years post baseline
|
Based on two items with four response categories.
The mean score will be calculated.
|
2 years post baseline
|
Gender attitudes (13 items measuring acceptability of spousal violence, girls schooling, male respect for women in decision-making and appropriateness of women's participation)
Time Frame: 2 years post baseline
|
Mean score
|
2 years post baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC025-8/2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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