An interventional study of Right to Play-Plus (RTP-Plus) and Control in Mental Health, Gender Based Violence and Resilience, sponsored by Aga Khan University. Recruiting at 2 sites in Pakistan. Open to participants aged 10 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by Aga Khan University · Not applicable, Interventional, and Health services research
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.
Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
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)
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
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of intervention after 2 years.
Change in attitudes towards gender equality
A 5-item scale was adapted from Nancy Perrin, et al (2019) to measure the personal beliefs of children about gender equality. All items will be measured on a binary scale from 0 to 1 where 0 refers to disagree, and 1 refers to agree. Item 1 will be reverse coded. The results will reflect the proportion of having progressive gender beliefs.
Time frame: From enrollment to the end of intervention after 2 years.
Change in acceptability of violence against women
An adapted scale from Nancy Perrin, et al (2019) will be used to measure personal beliefs of justifying a man to hit his wife. All 6 items will be measured on a binary scale from 0 to 1 where 0 (no) refers to disagree, and 1 (yes) refers to agree. The results will reflect the proportion of respondents with conservative beliefs accepting domestic violence against women.
Time frame: From enrollment to the end of intervention after 2 years.
Change in beliefs about child marriage
An adapted 5-item scale from Perrin, N et al, 2019 to measure personal beliefs about girls being married at an early age. All items will be measured on a binary scale from 0 to 1 where 0 refers to disagree, and 1 refers to agree. Item 5 will be reverse-coded. The overall score ranges from 0 to 5, with higher scores reflecting conservative beliefs accepting child marriage.
Time frame: From enrollment to the end of intervention after 2 years.
Change in peer violence perpetration
A 10-item scale adapted from the peer perpetration scale from the Multidimensional Scale of Peer Violence is used to measure physical and emotional violence. All items will be measured on a binary scale from 0 to 1 where 0 (No) refers to did not do the act, and 1 (Yes) refers to did the act. The overall score ranges from 0 to 10, with higher scores reflecting the carrying out of the act of peer perpetration violence.
Time frame: From enrollment to the end of intervention after 2 years.
Increased resilience
The 10-item Connor-Davidson Resilience Scale (CD-RISC-10) was extracted from the original 25-item Connor-Davidson Resilience Scale (CD-RISC-25)(Campbell-Sills and Stein, 2007). Item responses range from 0 ("not true at all") to 4 ("true nearly all of the time"). The overall score ranges from 0 to 40, with higher scores reflecting a greater ability to cope with adversity.
Time frame: From enrollment to the end of intervention after 2 years.
Change in depression
The Patient Health Questionnaire 9 will be used to measure depression. All items will be measured on a binary scale from 0 to 1 where 0 refers to Not at All, and 1 refers to Yes (at least once or more). The results will reflect the proportion of symptoms of depression.
Time frame: From enrollment to the end of intervention after 2 years.
Change in sexual health confidence
This is a secondary outcome that the intervention partners will observe. This will be assessed with a self-developed tool with 5 items. It comprises of 5-point Likert scale to rate the individual's evaluation ranging from 1 (Strongly Disagree) to 5 (Strongly Agree), where higher scores mean more confident.
Time frame: From enrollment to the end of intervention after 2 years.
Plan to share: No — 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.
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