Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
8200

Summary

Conditions
  • Mental Health Wellness 1
  • Resilience, Psychological
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Younger than 18 years
Gender
Both males and females

Description

This protocol is designed to answer key questions about the effects of Youth First on mental and sexual reproductive health, educational wellbeing and substance use. A mixed-methods, cluster randomized trial will assess the impact of the Youth First program over time. This component of the Youth Fir...

This protocol is designed to answer key questions about the effects of Youth First on mental and sexual reproductive health, educational wellbeing and substance use. A mixed-methods, cluster randomized trial will assess the impact of the Youth First program over time. This component of the Youth First impact evaluation will take place across 70 schools (40 schools that are new to the Youth First intervention, 30 control schools) with 7th and 8th Standard students located within two districts in the state of Bihar, India, specifically Patna and Darbhanga. This study will follow two cohorts of students: one of 8th Standard students and the other 7th Standard. This will include surveys conducted at baseline and at three follow-up time periods across a period of 32 months post-baseline (follow-up data collection at 8 (T1), 20 (T2), 32 (T3) months) to determine the short and long-term impact and additive effects of multiple years of Youth First. Eighth standard students will be followed through the end of 10th standard; the 7th standard cohort will be followed through the end of 9th. Both students who stay in school and those who leave will be followed up. Quantitative data will be collected from 7th Standard (n=4500) and 8th Standard (n=3690) boys and girls across 100 schools in the two sub-studies, for a total study population of N=8190 students. Monitoring data from schools (e.g. number of sessions implemented, adherence to curriculum, etc.) collected as part of program implementation will inform a process evaluation of program quality and fidelity. Qualitative data will be collected from students after the completion of the Youth First program at the end of 8th Standard and at the end of T3. Findings from this program are expected to provide much-needed evidence about the long-term effects of programs to address the psychosocial needs of youths in India, as well as information on the scalability of such a program within the school setting. It is expected that the findings from this study will be used by policy makers to inform decision making around the implementation of Youth First or similar programs within the state of Bihar and nationwide.

Tracking Information

NCT #
NCT03705208
Collaborators
David and Lucile Packard Foundation
Investigators
Principal Investigator: Catherine Elkins, PhD CorStone