Evaluation of Right To Play's Positive Child and Youth Development Program in Middle Schools in Hyderabad, Pakistan

February 28, 2018 updated by: Medical Research Council, South Africa

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

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.

Study Overview

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

Interventional

Enrollment (Actual)

1752

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
  1. Right To Play's Red Ball Child Play manual provided for 60 hours per annum for two years
  2. Training of junior leaders
  3. Related play-based activities such as sports days
  4. Quarterly awareness sessions with community groups and parents
  5. Summer camps for children
  6. training of teachers on Right To Play's foundational resources, positive disciplining, and gender and child protection
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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Anticipated)

March 9, 2018

Study Completion (Anticipated)

August 31, 2018

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

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)?

NO

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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