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Extended Evaluation of School-based Health Promotion Programmes in Bihar, India (SEHER+)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907125
First Posted: September 20, 2016
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
London School of Hygiene and Tropical Medicine
Public Health Foundation of India
Information provided by (Responsible Party):
Sangath
  Purpose

SEHER Plus- Strengthening Evidence base on scHool-based intErventions for pRomoting adolescent health, seeks to evaluate a school based adolescent health promotion intervention delivered by two different delivery agents viz. teacher-as-SEHER Mitra (TSM) and lay school counsellor called as SEHER Mitra (SM) in government- run secondary schools in Bihar, India. SEHER Plus will be implemented in the same randomly assigned 74 schools wherein, the SEHER trial (ClinicalTrials.gov ID: NCT02484014)-a three armed clustered randomised trial (CRT) was implemented to evaluate the effectiveness and cost-effectiveness of these two models compared with the Tarang-Adolescence Education Programme (usual care) implemented by the State Government of Bihar.

The SEHER trial hypothesised that both interventions, compared to the control arm, would lead to a greater impact on school climate (school connectedness and relationship with teachers and fellow students). In addition, the interventions would increase the knowledge, attitude and awareness, and promoting healthy behaviours in youth on reproductive and sexual health outcomes, mental health and substance use, and gender related attitudes and violence. The SEHER trial also hypothesized that the addition of more resource intensive component (the SM arm) would be associated with the best outcomes. The hypothesis for the SEHER Plus is that students who will have exposure to the SEHER intervention activities in two academic years (Class IX and X) will show greater benefits on the primary, secondary and exploratory outcomes than students who have exposure to the SEHER intervention activities in one academic year (Class IX).


Condition Intervention
Health Promotion Behavioral: SEHER Intervention delivered by TSM Behavioral: SEHER Intervention delivered by SM Behavioral: Tarang AEP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Strengthening the Evidence Base on Effective scHool Based intErventions for pRomoting Adolescent Health (SEHER)

Further study details as provided by Sangath:

Primary Outcome Measures:
  • School Climate [ Time Frame: Up to 7 months ]
    The school climate will be measured through Beyond Blue School Climate Scale (28 items)


Secondary Outcome Measures:
  • Self-reported bully behaviour [ Time Frame: Up to 7 months ]
    The bully behaviour will be measured through adapted version of Illinois Bullying Scale (4 items)

  • self-reported violence [ Time Frame: Up to 7 months ]
    This outcome measure will be assessed through adapted version of Global School-based student Health Survey (4 items)

  • Attitude towards gender equity [ Time Frame: Up to 7 months ]
    This outcome measure will be assessed through adapted version of Gender Equitable Men Survey (GEMS) 10 items.

  • Knowledge and attitude towards Reproductive and Sexual Health [ Time Frame: Up to 7 months ]
    This outcome measure will be assessed through 10 self-reported items based on the WHO's illustrative questionnaire for interview/survey with young people

  • Depression [ Time Frame: Up to 7 months ]
    This outcome will be assessed through the Patient Health Questionnaire-9


Other Outcome Measures:
  • Self-reported substance use [ Time Frame: Up to 7 months ]
    This outcome will be assessed through adapted version of Global School-based student Health Survey

  • Self-reported sexual behaviour [ Time Frame: Up to 7 months ]
    This outcome will be assessed through adapted version of Global School-based student Health Survey

  • Self-reported suicide attempts [ Time Frame: Up to 7 months ]
    This outcome will be assessed through adapted version of Global School-based student Health Survey


Enrollment: 29527
Study Start Date: June 15, 2016
Study Completion Date: March 30, 2017
Primary Completion Date: March 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TSM arm

The SEHER intervention will be delivered by a trained teacher, called as Teacher-as-SEHER Mitra (Mitra meaning friend) or lay health worker called as SEHER Mitra being trained to facilitate following activitiesAwareness generation activities for all stakeholders in school; Wall-magazine, Speak-out box, Competitions, School Health Promotion Committee, School health policies, Peer groups of students of class IX and X students, Workshops and talks for all the students from standard IX, and for teachers, and Counselling and referral services for all the students in the school.

This intervention will be delivered in each school over the academic year.

Behavioral: SEHER Intervention delivered by TSM

SEHER Intervention The SEHER intervention will be delivered by a trained teacher, called as Teacher-as-SEHER Mitra (Mitra meaning friend) or lay health worker called as SEHER Mitra being trained to facilitate following activitiesAwareness generation activities for all stakeholders in school; Wall-magazine, Speak-out box, Competitions, School Health Promotion Committee, School health policies, Peer groups of students of class IX and X students, Workshops and talks for all the students from standard IX, and for teachers, and Counselling and referral services for all the students in the school.

This intervention will be delivered in each school over the academic year.

Other Name: TSM Arm
Behavioral: Tarang AEP
The comparison arm involves 'usual care' which in the study setting is the Tarang: Adolescence Education Programme comprising of 16 classroom sessions on process of growing-up, prevention of HIV/AIDS and other Sexually Transmitted Diseases (STDs), and prevention of substance and other drug abuse. This programme is delivered by a trained nodal teacher in the school over the academic year.
Other Name: Comparison arm
Experimental: SM arm

The SEHER intervention will be delivered by a lay health worker called as SEHER Mitra being trained to facilitate following activities: Awareness generation activities for all stakeholders in school; Wall-magazine, Speak-out box, Competitions, School Health Promotion Committee, School health policies, Peer groups of students of class IX and X students, Workshops and talks for all the students from standard IX, and for teachers, and Counselling and referral services for all the students in the school.

This intervention will be delivered in each school over the academic year.

Behavioral: SEHER Intervention delivered by SM

The SEHER intervention will be delivered by a lay health worker called as SEHER Mitra being trained to facilitate following activities: Awareness generation activities for all stakeholders in school; Wall-magazine, Speak-out box, Competitions, School Health Promotion Committee, School health policies, Peer groups of students of class IX and X students, Workshops and talks for all the students from standard IX, and for teachers, and Counselling and referral services for all the students in the school.

This intervention will be delivered in each school over the academic year.

Other Name: SM arm
Behavioral: Tarang AEP
The comparison arm involves 'usual care' which in the study setting is the Tarang: Adolescence Education Programme comprising of 16 classroom sessions on process of growing-up, prevention of HIV/AIDS and other Sexually Transmitted Diseases (STDs), and prevention of substance and other drug abuse. This programme is delivered by a trained nodal teacher in the school over the academic year.
Other Name: Comparison arm
Active Comparator: Comparison arm Tarang AEP
The comparison arm involves 'usual care' which in the study setting is the Tarang: Adolescence Education Programme comprising of 16 classroom sessions on process of growing-up, prevention of HIV/AIDS and other Sexually Transmitted Diseases (STDs), and prevention of substance and other drug abuse. This programme is delivered by a trained nodal teacher in the school over the academic year.
Behavioral: Tarang AEP
The comparison arm involves 'usual care' which in the study setting is the Tarang: Adolescence Education Programme comprising of 16 classroom sessions on process of growing-up, prevention of HIV/AIDS and other Sexually Transmitted Diseases (STDs), and prevention of substance and other drug abuse. This programme is delivered by a trained nodal teacher in the school over the academic year.
Other Name: Comparison arm

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All the students enrolled in class IX in academic year March 2015- April 2016 and enrolled in class IX in academic year March 2016- April 2017 in all the randomly assigned 74 schools will be invited to participate in the study.

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907125


Locations
India
Sangath
Bardez, Goa, India, 403501
Sponsors and Collaborators
Sangath
London School of Hygiene and Tropical Medicine
Public Health Foundation of India
Investigators
Principal Investigator: Vikram Patel, FMedSci Professor of International Mental Health and Wellcome Trust Senior Research Fellow in Clinical Science; Centre for Global Mental Health, London School of Hygiene and Tropical Medicine, UK; and Sangath
  More Information

Responsible Party: Sangath
ClinicalTrials.gov Identifier: NCT02907125     History of Changes
Other Study ID Numbers: SANSEHER2016_0001
First Submitted: September 15, 2016
First Posted: September 20, 2016
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes