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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
Medical Research Council, South Africa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peer Violence

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 22, 2018
    Last Updated
    February 28, 2018
    Sponsor
    Medical Research Council, South Africa
    Collaborators
    Aga Khan University, Texas Woman's University
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    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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