Youth First: A Longitudinal Impact Evaluation

NCT ID: NCT03705208

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 7762 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-08
• Study Completion Date: 2021-12-31

Brief Summary

This trial will assess the effect of school-based emotional resilience and health curriculum, called Youth First, on middle school students who receive the curriculum in 7th and 8th grades. Key psychosocial wellbeing, mental health, educational wellbeing and substance use measures, will be assessed longitudinally over a three year period using a cluster randomized control design.

Detailed 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 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.

Conditions

Resilience, Psychological; Mental Health Wellness 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Youth First Curriculum

The full Youth First curriculum provides holistic training of both emotional resilience and adolescent health concepts. The curriculum is comprised of a 15-session emotional resilience curriculum and a 10-session adolescent health program. The resilience curriculum aims to increase both internal assets (such as self-esteem, coping skills, health knowledge, and conflict-resolution skills) and external assets (such as positive bonds with peers and family).

The adolescent health curriculum provides in-depth training in physical health and wellness topics such as sexual and reproductive health, common diseases, nutrition, gender equality, and substance use.

The curriculum is imparted by school teachers are trained and certified by CorStone.

Group Type: EXPERIMENTAL

Youth First Curriculum

Intervention Type: OTHER

A 25 session emotional resilience and health curriculum designed for 7th and 8th grade students.

School as usual

This arm is comprised of students attending school as usual and receiving the established government-designed curriculum.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Youth First Curriculum

A 25 session emotional resilience and health curriculum designed for 7th and 8th grade students.

Intervention Type: OTHER

Other Intervention Names

School-based emotional resilience and health curriculum

Eligibility Criteria

Inclusion Criteria

• All students enrolled in 7th or 8th grades at one of the schools selected for the study.

School Selection Criteria are:

• Government-run schools classified as rural and located in Darbhanga or Patna districts
• Have a minimum of 30 students enrolled in each of 7th and 8th Standards
• Have a high level of commitment from the principal to implement Youth First in both 7th and 8th grades, including willingness to have their teachers attend the training sessions and take the time to carry out the weekly sessions with the students.
• Have a high level commitment from the teachers of 7th and 8th Standards to participate in Youth First sessions, which includes taking part in all 3 trainings and holding weekly Youth First sessions.
• Have a physical space regularly available in which sessions could be held (relatively private and quiet, clean and uncluttered)
• Have a regular student teacher ratio of 50:1 or below (based on data reported in U-DISE)
• Accessible by a bus or taxi ride not greater than 3 hours from the nearest urban center.
• Classified as rural school by the Bihar Education Program Council

Exclusion Criteria

• Have experienced a delay in starting the school year in AY2017/18.
• Have experienced extensive flooding in AY2017/18.
• Currently implementing a similar emotional resilience or life skills program in the middle school levels.
• Located in Naxal-affected area

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

David and Lucile Packard Foundation

OTHER

Sponsor Role: collaborator

CorStone

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Elkins, PhD

Role: PRINCIPAL_INVESTIGATOR

CorStone

Locations

CorStone India Foundation

New Delhi, , India

Countries

India

Other Identifiers

01-YF-IN-2018-V1

Identifier Type: -

Identifier Source: org_study_id