Clinical trial NCT03448523: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Peer Violence
Depression
Lead sponsor: Medical Research Council, South Africa
Sponsor class: OTHER
Collaborators: name: Aga Khan University
name: Texas Woman's University
First posted: 2018-02-28
Enrollment: 1752
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label, randomised, efficacy study
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Peer violence victimisation in the past 4 weeks
timeFrame: assessment 2 years post-baseline
measure: Peer violence perpetration in the past 4 weeks
timeFrame: assessment 2 years post-baseline
measure: Depression
timeFrame: Over last 2 weeks
Secondary outcomes:
measure: School performance
timeFrame: 2 years post baseline
measure: Days of school missed in last 4 weeks
timeFrame: 2 years post-baseline
measure: preparations for marriage
timeFrame: 2 years post baseline
measure: Corporal punishment in the past 4 weeks
timeFrame: 2 years post baseline
measure: Physical punishment at home in past 4 weeks
timeFrame: 2 years post baseline
measure: Gender attitudes (13 items measuring acceptability of spousal violence, girls schooling, male respect for women in decision-making and appropriateness of women's participation)
timeFrame: 2 years post baseline
Other outcomes:
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