Mental HealthRTP-PlusNCT06777849
Mainstreaming a Life Skills Education Programme Right to Play- Plus to Reduce Violence Against Girls in Pakistan
A study testing Right to Play-Plus (RTP-Plus) in people with Mental Health and Gender Based Violence, run by Aga Khan University at 2 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Gender Based Violence, Resilience
- What is being tested?
- Right to Play-Plus (RTP-Plus)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 2 sitesPakistan
- Study dates
- 18 Dec 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Schools where Right to Play or Aahung have already implemented their play-based/other activities.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Korangi
Karachi, Sindh
Dr. Fouzia Khan, 922199213486, drfouziakhan@gmail.com
- Recruiting
Malir
Karachi, Sindh
Dr. Fouzia Khan, 922199213486, drfouziakhan@gmail.com
About this study
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:
Read more
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.
- Conditions
- Mental Health, Gender Based Violence, Resilience, Gender Equity, Sexual and Reproductive Health and Rights
- Being tested
- Right to Play-Plus (RTP-Plus), Control
- Keywords
- GBV, adolescent health, play-based life skills, what works
- Medical subject headings
- Psychological Well-Being, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right to Play-Plus (RTP-Plus)Behavioural
Also called What Works 2
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of intervention after 2 years.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of intervention after 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start18 Dec 2024
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University
- Responsible party
- Principal investigator, Dr Rozina Karmaliani, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777849
- Sponsor's protocol ID
- 2024-9681-30134
- Other IDs
- 22-SC35-INT
- Acronym
- RTP-Plus
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mainstreaming a Life Skills Education Programme Right to Play- Plus to Reduce Violence Against Girls in Pakistan
- ClinicalTrials.gov ID
- NCT06777849
- Acronym / sponsor ID
- RTP-Plus / 2024-9681-30134
- Conditions
- Mental Health, Gender Based Violence, Resilience, Gender Equity, Sexual and Reproductive Health and Rights
- Keywords
- GBV, adolescent health, play-based life skills, what works
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- George Washington University
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Right to Play-Plus (RTP-Plus)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. |
| Control | Other | Other: ControlThe 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. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Schools where Right to Play or Aahung have already implemented their play-based/other activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right to Play-Plus (RTP-Plus)Also: What Works 2The 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. | Behavioural | Intervention |
| ControlThere 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. | Other | Control |
Primary outcome
Change in physical, emotional, and sexual violence
Time frame: From enrollment to the end of intervention after 2 years.
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.
Change in cyber sexual harassment
Time frame: From enrollment to the end of the intervention after 2 years.
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.
Increased self-efficacy to respond to violence
Time frame: From enrollment to the end of intervention after 2 years.
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.
7 secondary outcomes
Change in attitudes towards gender equality
Time frame: From enrollment to the end of intervention after 2 years.
Change in acceptability of violence against women
Time frame: From enrollment to the end of intervention after 2 years.
Change in beliefs about child marriage
Time frame: From enrollment to the end of intervention after 2 years.
Change in peer violence perpetration
Time frame: From enrollment to the end of intervention after 2 years.
Increased resilience
Time frame: From enrollment to the end of intervention after 2 years.
Change in depression
Time frame: From enrollment to the end of intervention after 2 years.
Change in sexual health confidence
Time frame: From enrollment to the end of intervention after 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right to Play-Plus (RTP-Plus) in people with Mental Health and Gender Based Violence, run by Aga Khan University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rozina Karmaliani, PhD (923212557676, rozina.karmaliani@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical, emotional, and sexual violence (time frame: From enrollment to the end of intervention after 2 years.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.