NCT03705208

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,762

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 4, 2021

Status Verified

July 1, 2021

Enrollment Period

3.2 years

First QC Date

October 10, 2018

Last Update Submit

July 28, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Number of student reporting being enrolled and regularly attending school

    Participants are enrolled in a grade-appropriate school at the end of the study period

    32 months

  • Substance use

    Self-reported use of tobacco, alcohol or drugs.

    32 months

  • Mental health

    Strengths and Difficulties Questionnaire, internalizing problems subscale: Sum of 10 items, score range of 0-20, with lower score indicating better outcomes. KIDSCREEN psychological wellbeing: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.

    32 months

  • Physical Health

    KIDSCREEN Physical wellbeing subscale: sum of 5 items, score range of 0-20 with higher score indicating better outcomes.

    32 months

Secondary Outcomes (4)

  • Gender equitable attitudes

    8, 20 and 32 months

  • Emotional Resilience

    8, 20 and 32 months

  • Self-efficacy

    8, 20 and 32 months

  • Social Wellbeing

    8, 20 and 32 months

Study Arms (2)

Youth First Curriculum

EXPERIMENTAL

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.

Other: Youth First Curriculum

School as usual

NO INTERVENTION

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

Interventions

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

Also known as: School-based emotional resilience and health curriculum
Youth First Curriculum

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CorStone India Foundation

New Delhi, India

Location

Study Officials

  • Catherine Elkins, PhD

    CorStone

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 15, 2018

Study Start

May 8, 2018

Primary Completion

August 1, 2021

Study Completion

December 1, 2021

Last Updated

August 4, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations