- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07434531
Feasibility & Acceptability of a Culturally Adapted Socio Emotional Learning Intervention for Pakistani Adolescents
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Islamabad, Pakistan, 540007
- NUST
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Students enrolled in Grade 6
- Present at school on the day of the baseline assessment, the endpoint outcome assessment, or both
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Magnificent Mei & Friends Intervention
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.
|
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.
|
|
No Intervention: Enhanced Treatment-as-usual
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From baseline to one day post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Symptoms Checklist
Time Frame: from baseline to one day post-intervention
|
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.
|
from baseline to one day post-intervention
|
|
Revised Children's Anxiety and Depression Scale (RCADS)
Time Frame: From baseline to one day post-intervention
|
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.
|
From baseline to one day post-intervention
|
|
Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWS)
Time Frame: from baseline to one day post-intervention
|
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.
|
from baseline to one day post-intervention
|
|
Bullying Victimization Questionnaire
Time Frame: from baseline to one day post-intervention
|
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.
|
from baseline to one day post-intervention
|
|
Study Specific Feasibility Assessment Questionnaire
Time Frame: one day post intervention
|
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. |
one day post intervention
|
|
Qualitative Evaluation of Intervention Acceptability
Time Frame: one day post intervention
|
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.
|
one day post intervention
|
Collaborators and Investigators
Investigators
- Study Chair: Sitwat Usman Langrial, National University of Sciences and Technology, Pakistan
- Study Director: Joanna Lai, United Nations International Children's Emergency Fund
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0839/Ethic/07S3H/87/DBS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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