Mental HealthNCT07434531
Feasibility & Acceptability of a Culturally Adapted Socio Emotional Learning Intervention for Pakistani Adolescents
A study testing Magnificent Mei & Friends Comic Series in people with Mental Health, run by National University of Science and Technology, Pakistan at 1 site in Pakistan.
Trial summary
The aim of the study is to improve socioemotional learning skills of adolescents in public school settings of Rawalpindi, Pakistan. The objective of the present study is to evaluate the feasibility and acceptability of culturally adapted social and emotional learning intervention through feasibility cluster randomized… Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Magnificent Mei & Friends Comic Series
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2026to 20 Apr 2026
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students enrolled in Grade 6
- Present at school on the day of the baseline assessment, the endpoint outcome assessment, or both
Who cannot join
- The adolescents will be excluded if the they
- are at high risk of imminent suicide as reported by the students themselves or parents/primary caregivers, or identified by the trained assessment team during assessments.
- have acute medical conditions who require immediate or ongoing inpatient medical or psychiatric care, as reported by students themselves or parents/primary caregivers or identified by the trained assessment team during assessments.
- have deafness, blindness and speech difficulties or with severe mental, neurological or substance use disorders (e.g., psychosis, mutism, intellectual disability, autism or drug dependence) identified by the trained assessment team during assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility and Acceptability of Implementing and Scaling up a Culturally Adapted Universal Socio-emotional Intervention for School-going Adolescents in Rawalpindi, Pakistan: A Feasibility Cluster Randomized Controlled Trial (cRCT)
The aim of the study is to improve socioemotional learning skills of adolescents in public school settings of Rawalpindi, Pakistan. The objective of the present study is to evaluate the feasibility and acceptability of culturally adapted social and emotional learning intervention through feasibility cluster randomized controlled trial.
In the current study, 4 schools will be randomized to intervention and control arms, stratified by gender.
The study participants will be adolescents studying in government schools.
Read the detailed description
The current study is a two-arm, single-blinded, feasibility cluster randomized controlled trial that will be conducted in 4 middle and high schools in Rawalpindi, Pakistan. 4 schools, stratified by gender, will be randomized on a 1:1 allocation ratio into intervention (n = 2) and enhanced treatment-as-usual (n=2) arms. Approximately 120 adolescents of both genders, aged 10-14, studying in grade 6 of elementary public schools will be included in the study. A facilitator will deliver the intervention in the classrooms. The intervention components are empirically supported and include emotional regulation, stress management, problem solving, assertiveness, drug and alcohol knowledge, and interpersonal skills. The treatment as usual across both arms will be enhanced by conducting a 40-minute awareness-raising seminar on promoting mental health among adolescents through schools. The objective of the study is to evaluate the feasibility and acceptability of culturally adapted social and emotional learning intervention along with evaluating the preliminary impact of the culturally adapted intervention on the knowledge, attitude, and practice of Social and Emotional Abilities (SEA) in school-going adolescents in Rawalpindi, Pakistan.
- Conditions
- Mental Health
- Being tested
- Magnificent Mei & Friends Comic Series
- Keywords
- adolescent mental health, socioemotional skills, helping adolescent thrive, feasibility, acceptability, randomized controlled trial
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnificent Mei & Friends Comic SeriesBehavioural
It is a multicomponent universal intervention that has been designed to promote socioemotional life skills among adolescents 10-14. Based on evidence-based effective program components, the intervention has potential to improve adolescent mental health and reduce risky behavior. It is resource-effective where the facilitator learns skills through self-study and reflection. The intervention comprises empirically supported strategies, delivered via group sessions in classroom. Each session is further subdivided; the individual subdivided session lasts from 20 minutes to 30 minutes. The intervention material consists of 1. Magnificent Mei and Friends Comic Series 2. Facilitator's Guide to the Magnificent Mei \& Friends Comic Series. The comics represent life scenarios and situations young adolescents face in their daily lives. With the help of the comics, the facilitator teaches social and emotional skills to adolescents.
| Study group | Role | What they receive |
|---|---|---|
| Magnificent Mei & Friends Intervention | Experimental | It is a multicomponent universal intervention that has been designed to promote socioemotional life skills among adolescents 10-14. Based on evidence based effective program components, the intervention has potential to improve adolescent mental health and reduce risky behavior. It is resource-effective where the facilitator learns skills through self-study and reflection. The intervention comprises empirically supported strategies, delivered via group sessions in classroom. Each session is further subdivided; the individual subdivided session lasts from 20 minutes to 30 minutes. The intervention material consists of 1. Magnificent Mei and Friends Comic Series 2. Facilitator's Guide to the Magnificent Mei \& Friends Comic Series. The comics represent life scenarios and situations young adolescents face in their daily lives. With the help of the comics, the facilitator teaches social and emotional skills to adolescents. Receives: Behavioral: Magnificent Mei & Friends Comic Series |
| Enhanced Treatment-as-usual | No intervention | Mental health services are not available in public schools of Pakistan to promote mental health and wellbeing of children and adolescents; therefore, the treatment as usual across both arms will be enhanced by conducting a 40 minutes awareness raising seminar on promoting mental health among adolescents through schools. In these seminars the teachers and adolescents will receive mental health awareness information from the study lead. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Emotional Abilities and Learning (SEAL)
It is 36 items tool designed to measure socioemotional abilities of adolescents. The items are rated on three-point Likert scale, where yes has the highest score (2), No has the score of (1) and maybe has the lowest score of (0) (UNICEF, 2021).Higher scores indicate stronger socio-emotional knowledge, skills, and positive practices, while lower scores indicate poorer socio-emotional competencies and awareness.
Measured: From baseline to one day post-intervention
Secondary outcomes (6)
Pediatric Symptoms Checklist
It is a well established 35 items scale. It consists of three subscales: internalizing, externalizing and attention problems (Jellinek et al., 1988). The Urdu version has been previously adapted and used in Pakistan, showing satisfactory reliability and validity (Hamdani et al., 2024; 2022). Higher scores reflect greater levels of emotional and behavioral problems (internalizing, externalizing, and attention difficulties), while lower scores indicate fewer psychosocial problems.
Measured: from baseline to one day post-intervention
Revised Children's Anxiety and Depression Scale (RCADS)
RCADS is a 25-item instrument (on a 4-point Likert scale; transformed scores range 0-100) to measure levels of anxiety and low mood. It has two subscales (anxiety \& depression). This tool has also been translated into the Urdu language previously and used successfully in Pakistan (Hamdani et al., 2024). Higher scores indicate higher levels of anxiety and depressive symptoms, whereas lower scores indicate fewer symptoms of anxiety and low mood.
Measured: From baseline to one day post-intervention
Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWS)
it is a 7-item scale and assesses the mental wellbeing by evaluating the functioning of thoughts and feelings in the past two weeks. Items are rated on Likert scale that ranges from "none of the time" to "all of the time". The total score is calculated by summing the responses on all the items (Tennant et al., 2007). This tool has also been translated into the Urdu language and validated previously (Hamdani et al., 2022). Higher scores indicate better mental wellbeing and more positive functioning of thoughts and feelings, while lower scores indicate poorer mental wellbeing.
Measured: from baseline to one day post-intervention
Bullying Victimization Questionnaire
Experience of bullying in the past 30 days will be measured through the contextualized version of the Bullying Victimization Questionnaire. The total score can range from 0 to 12. Higher scores indicate more frequent experiences of bullying victimization, while lower scores indicate fewer or no experiences of being bullied by peers.
Measured: from baseline to one day post-intervention
Study Specific Feasibility Assessment Questionnaire
Quantitatively Feasibility assessment will be done in terms of rate of recruitment, number of sessions delivered to the study participants, number of participants in the sessions who received the intervention, duration of sessions delivered, and retention at follow-up assessment.
Qualitatively feasibility assessment will be done to explore the extent to which it was feasible to train non-specialist facilitators and delivery of the intervention in the school settings.
Measured: one day post intervention
Qualitative Evaluation of Intervention Acceptability
Acceptability will be assessed through qualitative assessments with the stakeholders in Semi Structured Interviews to assess acceptability, feasibility, facilitators, and barriers of the intervention strategies implemented, and challenges faced by the intervention facilitators during intervention delivery. The Focus Group Discussions with adolescents will explore the intervention strategies applied by the participants in the sessions, challenges faced in the application of the intervention strategies by the participants in real life, perceived usefulness, ease of use, comprehensibility for most/least helpful components, suggestions for improvement, and intent to continue behaviors/engagement with the intervention. The perception of the implementation in school settings will also be explored in terms of non-specialist as delivery agents, their training and supervision, the experience or perception of delivering the intervention.
Measured: one day post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Apr 2026
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Apr 2026 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study will be a feasibility cluster randomized controlled trial, in which 4 schools will be randomized to intervention and control arms, stratified by gender.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Science and Technology, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syeda Wajeeha Zafar, National University of Science and Technology, Pakistan
- Investigators
- Sitwat Usman Langrial, Study chair, National University of Sciences and Technology, PakistanJoanna Lai, Study director, United Nations International Children's Emergency Fund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434531
- Sponsor's protocol ID
- 0839/Ethic/07S3H/87/DBS
- Status last verified
- Apr 2026
- First submitted
- 8 Feb 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Implementing and Scaling up a Culturally Adapted Universal Socio-emotional Intervention for School-going Adolescents in Rawalpindi, Pakistan: A Feasibility Cluster Randomized Controlled Trial (cRCT)
- ClinicalTrials.gov ID
- NCT07434531
- Acronym / sponsor ID
- 0839/Ethic/07S3H/87/DBS
- Conditions
- Mental Health
- Keywords
- adolescent mental health, socioemotional skills, helping adolescent thrive, feasibility, acceptability, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National University of Science and Technology, PakistanUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 25 Feb 2026 (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.
The aim of the study is to improve socioemotional learning skills of adolescents in public school settings of Rawalpindi, Pakistan. The objective of the present study is to evaluate the feasibility and acceptability of culturally adapted social and emotional learning intervention through feasibility cluster randomized controlled trial.
In the current study, 4 schools will be randomized to intervention and control arms, stratified by gender.
The study participants will be adolescents studying in government schools.
Detailed description
The current study is a two-arm, single-blinded, feasibility cluster randomized controlled trial that will be conducted in 4 middle and high schools in Rawalpindi, Pakistan. 4 schools, stratified by gender, will be randomized on a 1:1 allocation ratio into intervention (n = 2) and enhanced treatment-as-usual (n=2) arms. Approximately 120 adolescents of both genders, aged 10-14, studying in grade 6 of elementary public schools will be included in the study. A facilitator will deliver the intervention in the classrooms. The intervention components are empirically supported and include emotional regulation, stress management, problem solving, assertiveness, drug and alcohol knowledge, and interpersonal skills. The treatment as usual across both arms will be enhanced by conducting a 40-minute awareness-raising seminar on promoting mental health among adolescents through schools. The objective of the study is to evaluate the feasibility and acceptability of culturally adapted social and emotional learning intervention along with evaluating the preliminary impact of the culturally adapted intervention on the knowledge, attitude, and practice of Social and Emotional Abilities (SEA) in school-going adolescents in Rawalpindi, Pakistan.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study will be a feasibility cluster randomized controlled trial, in which 4 schools will be randomized to intervention and control arms, stratified by gender.
| Arm | Type | Receives |
|---|---|---|
| Magnificent Mei & Friends Intervention | Experimental | Behavioral: Magnificent Mei & Friends Comic SeriesIt is a multicomponent universal intervention that has been designed to promote socioemotional life skills among adolescents 10-14. Based on evidence based effective program components, the intervention has potential to improve adolescent mental health and reduce risky behavior. It is resource-effective where the facilitator learns skills through self-study and reflection. The intervention comprises empirically supported strategies, delivered via group sessions in classroom. Each session is further subdivided; the individual subdivided session lasts from 20 minutes to 30 minutes. The intervention material consists of 1. Magnificent Mei and Friends Comic Series 2. Facilitator's Guide to the Magnificent Mei \& Friends Comic Series. The comics represent life scenarios and situations young adolescents face in their daily lives. With the help of the comics, the facilitator teaches social and emotional skills to adolescents. |
| Enhanced Treatment-as-usual | No intervention | –Mental health services are not available in public schools of Pakistan to promote mental health and wellbeing of children and adolescents; therefore, the treatment as usual across both arms will be enhanced by conducting a 40 minutes awareness raising seminar on promoting mental health among adolescents through schools. In these seminars the teachers and adolescents will receive mental health awareness information from the study lead. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Students enrolled in Grade 6
- Present at school on the day of the baseline assessment, the endpoint outcome assessment, or both
Key exclusion criteria (4 listed)
- The adolescents will be excluded if the they
- are at high risk of imminent suicide as reported by the students themselves or parents/primary caregivers, or identified by the trained assessment team during assessments.
- have acute medical conditions who require immediate or ongoing inpatient medical or psychiatric care, as reported by students themselves or parents/primary caregivers or identified by the trained assessment team during assessments.
- have deafness, blindness and speech difficulties or with severe mental, neurological or substance use disorders (e.g., psychosis, mutism, intellectual disability, autism or drug dependence) identified by the trained assessment team during assessments.
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 |
|---|---|---|
| Magnificent Mei & Friends Comic SeriesIt is a multicomponent universal intervention that has been designed to promote socioemotional life skills among adolescents 10-14. Based on evidence-based effective program components, the intervention has potential to improve adolescent mental health and reduce risky behavior. It is resource-effective where the facilitator learns skills through self-study and reflection. The intervention comprises empirically supported strategies, delivered via group sessions in classroom. Each session is further subdivided; the individual subdivided session lasts from 20 minutes to 30 minutes. The intervention material consists of 1. Magnificent Mei and Friends Comic Series 2. Facilitator's Guide to the Magnificent Mei \& Friends Comic Series. The comics represent life scenarios and situations young adolescents face in their daily lives. With the help of the comics, the facilitator teaches social and emotional skills to adolescents. | Behavioural | Magnificent Mei & Friends Intervention |
Primary outcome
Social Emotional Abilities and Learning (SEAL)
Time frame: From baseline to one day post-intervention
It is 36 items tool designed to measure socioemotional abilities of adolescents. The items are rated on three-point Likert scale, where yes has the highest score (2), No has the score of (1) and maybe has the lowest score of (0) (UNICEF, 2021).Higher scores indicate stronger socio-emotional knowledge, skills, and positive practices, while lower scores indicate poorer socio-emotional competencies and awareness.
6 secondary outcomes
Pediatric Symptoms Checklist
Time frame: from baseline to one day post-intervention
Revised Children's Anxiety and Depression Scale (RCADS)
Time frame: From baseline to one day post-intervention
Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWS)
Time frame: from baseline to one day post-intervention
Bullying Victimization Questionnaire
Time frame: from baseline to one day post-intervention
Study Specific Feasibility Assessment Questionnaire
Time frame: one day post intervention
Qualitative Evaluation of Intervention Acceptability
Time frame: one day post intervention
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 6 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Sitwat Usman Langrial study chair
National University of Sciences and Technology, Pakistan
Joanna Lai study director
United Nations International Children's Emergency Fund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnificent Mei & Friends Comic Series in people with Mental Health, run by National University of Science and Technology, Pakistan at 1 site 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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Emotional Abilities and Learning (SEAL) (time frame: From baseline to one day post-intervention). 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 6 Apr 2026.