Early Adolescent Skills for Emotions (EASE)-Pilot Cluster Randomized Controlled Trial (cRCT) in Public Schools of Rural Pakistan
Launched by HUMAN DEVELOPMENT RESEARCH FOUNDATION, PAKISTAN · Feb 1, 2020
Trial Information
Current as of June 02, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • The study participants will be 60 adolescents (aged 13-15), at-risk of psycho-social distress as assessed by self-reported Pediatric Symptoms Check list (score ≥ 28); studying in public schools of rural Rawalpindi, Pakistan and their primary caregivers. To estimate the magnitude of treatment effect and its variation for a sample size calculation in the definitive trial, a pilot study sample size of 24 - 50 has been recommended (Browne, 1995; Julious 2005). With a sample size of 60 (30 per arm), we aim to generate some reliable estimate of treatment effect as well as recruitment and attrition rates.
- • Adolescents in need of acute protection (at high risk of abuse or harm to self or others) and who require immediate or ongoing medical or psychiatric care reported by parents will be excluded from the study.
About Human Development Research Foundation, Pakistan
The Human Development Research Foundation (HDRF) in Pakistan is a prominent clinical trial sponsor dedicated to advancing health and well-being through innovative research. Focused on addressing critical health issues in the region, HDRF collaborates with local and international partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory guidelines. By leveraging its expertise in public health, epidemiology, and community engagement, HDRF aims to generate robust evidence that informs healthcare practices and policies, ultimately contributing to improved health outcomes for diverse populations in Pakistan and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Islamabad, , Pakistan
Patients applied
Trial Officials
Atif Rahman, PhD
Principal Investigator
University of Liverpool
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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