Clinical trial NCT03705208: Youth First: A Longitudinal Impact Evaluation
Official title: Long-term Evaluation of the Effects of Youth First on Social and Emotional Development, Gender Equity, and Health of Adolescents in Rural Bihar, India
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Resilience, Psychological
Mental Health Wellness 1
Lead sponsor: CorStone
Sponsor class: OTHER
Collaborators: name: David and Lucile Packard Foundation
First posted: 2018-10-15
Enrollment: 7762
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

* No exclusion criteria for students.

School exclusion criteria are:

* 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

Primary outcomes:
measure: Number of student reporting being enrolled and regularly attending school
timeFrame: 32 months
measure: Substance use
timeFrame: 32 months
measure: Mental health
timeFrame: 32 months
measure: Physical Health
timeFrame: 32 months
Secondary outcomes:
measure: Gender equitable attitudes
timeFrame: 8, 20 and 32 months
measure: Emotional Resilience
timeFrame: 8, 20 and 32 months
measure: Self-efficacy
timeFrame: 8, 20 and 32 months
measure: Social Wellbeing
timeFrame: 8, 20 and 32 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: CorStone India Foundation
Study officials:
affiliation: CorStone
name: Catherine Elkins, PhD
role: PRINCIPAL_INVESTIGATOR
References: