NCT06777849

Brief Summary

Right to Play-Plus (RTP-Plus) aims to address violence against women and girls by promoting changes in social norms among young people within the school environment. The project focuses on building the capacity of young people to identify harmful gender norms and prevent violence against girls and boys by incorporating Right to Play's play-based learning methodology and Aahung's Life Skills Based Education curriculum. The strategies employed include interactive, learner-centered methodologies, curricular activities, and the development of peer educators and junior leaders. Teachers play a crucial role as key influencers and delivery agents of the curricular content. The project emphasizes capacity development for teachers, challenging their social norms, strengthening their play-based methodologies, and improving their sexual and reproductive health and rights knowledge (SRHR). The ultimate goal is to equip teachers to effectively deliver a gender transformative curriculum, empowering young people to respond to and prevent violence. The research question for this study is: What is the effectiveness of an adapted play-based life skills education that incorporates a "whole school" approach in reducing sexual harassment and abuse, peer violence experiences, mental illness (including suicidal ideation), improving resilience, and promoting gender equity, SRHR knowledge in both home and public settings? The research objective will be achieved through two-arm cluster randomized controlled trial (for girls-only, co-ed, and boys-only schools). The intervention arm participants will be able to participate in the adapted play-based life skills education intervention, which the Right to Play and Aahung will deliver. It will be provided to all eligible school children in grade 6. Moreover, a delayed intervention will be offered to the control arm upon completion of endline data collection after the comprehensive intervention is delivered in the intervention arm.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Dec 2024May 2027

Study Start

First participant enrolled

December 18, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 2, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 17, 2025

Status Verified

December 1, 2024

Enrollment Period

2.1 years

First QC Date

January 2, 2025

Last Update Submit

January 15, 2025

Conditions

Keywords

GBVadolescent healthplay-based life skillswhat works

Outcome Measures

Primary Outcomes (3)

  • Change in physical, emotional, and sexual violence

    International Society for Prevention of Child Abuse and Neglect (ISPCAN)-Child Abuse Screening Tool for children (ICAST-C) is used to measure physical, emotional and sexual violence at home among children aged 11 to 18 years. It has been adapted for use in school settings in previous studies to measure child abuse at school. 12 items related to physical and emotional violence, and 9 items related to sexual violence will be used in the current study to measure physical, emotional and sexual violence at home, school, and community. Each item is measured if this incident happened with the child or not. If yes, then next column measures whether it happened in the past 4 weeks or not. Moreover, there are questions about the location of such an incident and the person who perpetrated it. These questions will yield data on the proportion of children affected by physical, emotional, and sexual violence, the location of perpetration, and the characteristics of perpetrators.

    From enrollment to the end of intervention after 2 years.

  • Change in cyber sexual harassment

    Following the same pattern of International Society for Prevention of Child Abuse and Neglect (ISPCAN)-Child Abuse Screening Tool for Children (ICAST-C) questions to measure physical, emotional, and sexual violence, a self-developed 6-item scale will be used to measure the prevalence (with answers yes (1), no (0), or don't know (-99)) of cyber sexual violence, its frequency in the past 4 weeks and the information on location and perpetrators. These questions will yield data on the proportion of children affected by cyber sexual violence, the location of perpetration, and the characteristics of perpetrators.

    From enrollment to the end of the intervention after 2 years.

  • Increased self-efficacy to respond to violence

    A self-developed 2-item scale adapted from the Self-Efficacy to Deal with Violence Scale to measure confidence in responding to an act of violence. All items will be measured on a binary scale from 0 to 1 where 0 (No) refers to not confident, and 1 (Yes) refers to confident. The results will reflect the proportion of having confidence in responding to violence.

    From enrollment to the end of intervention after 2 years.

Secondary Outcomes (7)

  • Change in attitudes towards gender equality

    From enrollment to the end of intervention after 2 years.

  • Change in acceptability of violence against women

    From enrollment to the end of intervention after 2 years.

  • Change in beliefs about child marriage

    From enrollment to the end of intervention after 2 years.

  • Change in peer violence perpetration

    From enrollment to the end of intervention after 2 years.

  • Increased resilience

    From enrollment to the end of intervention after 2 years.

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention arm participants will receive the adapted play-based life skills education intervention from teachers, which the Right to Play and Aahung will deliver.

Behavioral: Right to Play-Plus (RTP-Plus)

Control

OTHER

The control arm will not receive the intervention during the two years of cluster randomised control trial (cRCT). However, a delayed intervention will be offered to the control arm upon completion of endline data collection after the comprehensive intervention is delivered in the intervention arm.

Other: Control

Interventions

The comprehensive curriculum comprises of themes: "Social and Emotional Development" and "Sexual and Reproductive Health" will be delivered by school teachers who will receive training from Right to Play and Aahung. There will be 60 sessions for two years.

Also known as: What Works 2
Intervention
ControlOTHER

There will be no intervention given to control arm during two years of cluster randomised control trial (cRCT). However, a delayed intervention having teachers' training, will be provided to the control arm after the completion of endline for the duration of 3-4 months.

Control

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Schools will be chosen from District Malir and adjacent areas, including Korangi and East Karachi. Among the 100 selected schools, the following distribution will be maintained: 40 girls-only schools (public), 40 co-ed schools (private), and 20 boys-only schools (public).
  • Schools having a minimum of 30 students enrolled in grade 6
  • Private schools with low to medium fees, with monthly amounts ranging from PKR 2000 to 3500.
  • Factors such as teacher availability, school management support, accessibility to research and intervention partners, and school clustering will also be considered for the selection of these hundred schools.
  • Schools' willingness to adapt child protection and safeguarding/anti-harassment administrative measures and policies to improve school safety, reduce the use of corporal punishment, enhance school performance, and increase girls' retention rates, primarily apply to private schools.

You may not qualify if:

  • Schools where Right to Play or Aahung have already implemented their play-based/other activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Korangi

Karachi, Sindh, Pakistan

RECRUITING

Malir

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Psychological Well-BeingCoitus

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorSexual Behavior

Central Study Contacts

Rozina Karmaliani, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Associate Director

Study Record Dates

First Submitted

January 2, 2025

First Posted

January 16, 2025

Study Start

December 18, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

January 17, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

The personal identification of participants will not be disclosed to anyone, and identifiers will not be included in the dataset. Data analysis will be done using unique codes assigned to participants per their categories. All research findings will be written up so the identity of participants will be concealed.

Locations