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

Depression Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03448523
• Other study ID #: EC025-8/2015
• Status: Active, not recruiting
• Phase: N/A
• First received: February 22, 2018
• Last updated: February 28, 2018
• Start date: December 1, 2015
• Est. completion date: August 31, 2018

Study information

• Verified date: February 2018
• Source: Medical Research Council, South Africa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1752
• Est. completion date: August 31, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Peer Violence

Intervention

Behavioral:
• Right To Play's Positive Child and Youth Development program
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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Medical Research Council, South Africa	Aga Khan University, Texas Woman's University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peer violence victimisation in the past 4 weeks	Mean score on the sixteen questions on peer violence victimisation	assessment 2 years post-baseline
Primary	Peer violence perpetration in the past 4 weeks	Mean score on the sixteen questions on peer violence perpetration	assessment 2 years post-baseline
Primary	Depression	Score on the 28 items Children's Depression Inventory 2 (CDI 2)	Over last 2 weeks
Secondary	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	2 years post baseline
Secondary	Days of school missed in last 4 weeks	Mean	2 years post-baseline
Secondary	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.	2 years post baseline
Secondary	Corporal punishment in the past 4 weeks	Mean score across the 6 questions	2 years post baseline
Secondary	Physical punishment at home in past 4 weeks	Based on two items with four response categories. The mean score will be calculated.	2 years post baseline
Secondary	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	2 years post baseline