Evaluation of School-based Health Promotion Programmes in Bihar, India

NCT02484014 | Completed DMC

• 1 other identifier: SANSEHER2015_0001
• Study Type: interventional
• Target: 14,000
• Locations: 1 country
• Sites: 1

Brief Summary

SEHER- Strengthening Evidence base on scHool-based intErventions for pRomoting adolescent health, seeks to develop and 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 will implement a three armed clustered randomised trial (CRT) 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 hypothesis is that both interventions, compared to the control arm, will lead to a greater impact on school climate (school connectedness and relationship with teachers and fellow students). In addition, the interventions will 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. It is hypothesized that the addition of more resource intensive component (the SM arm) will be associated with the best outcomes.

Conditions

Health Promotion

Outcome Measures

Primary Outcomes (1)

• School Climate

  The school climate will be measured through Beyond Blue School Climate Scale (28 items)

  Up to 7 months

Secondary Outcomes (5)

• Bully behaviour

  Up to 7 months

• Violence

  Up to 7 months

• Attitude towards gender equity

  Up to 7 months

• Knowledge and attitude towards Reproductive and Sexual Health

  Up to 7 months

• Depression

  Up to 7 months

Other Outcomes (3)

• Substance use

  Up to 7 months

• Sexual behaviour

  Up to 7 months

• Suicide (thoughts and attempts)

  Up to 7 months

Study Arms (3)

TSM Arm

EXPERIMENTAL

Tarang Adolescence Education Programme + SEHER Intervention (delivered by teachers as SEHER Mitra)

Other: Tarang Adolescence Education programme; Other: SEHER Intervention

SM Arm

EXPERIMENTAL

Tarang Adolescence Education Programme + SEHER Intervention (delivered by SEHER Mitra)

Other: Tarang Adolescence Education programme; Other: SEHER Intervention

Comparison Arm

OTHER

Tarang Adolescence Education Programme

Other: Tarang Adolescence Education programme

Interventions

Tarang Adolescence Education programme OTHER

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.

Also known as: TARANG-AEP

Comparison Arm; SM Arm; TSM Arm

SEHER Intervention OTHER

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 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 standard IX * Workshops and talks for all the students from standard IX, and for teachers * Counselling and referral services for all the students in the school This intervention will be delivered in each school over the academic year.

SM Arm; TSM Arm

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Secondary and higher secondary schools
• Implementation of Tarang-Adolescence Education Programme
• or more students enrolled in Grade IX

You may not qualify if:

• Upgraded schools (Grade I-XII)
• Tarang-Adolescence Education Programme not being implemented
• Less than 100 students enrolled in Grade IX

Sponsors & Collaborators

• Sangath: lead
• London School of Hygiene and Tropical Medicine: collaborator
• Public Health Foundation of India: collaborator

Study Sites (1)

Sangath

Bardez, Goa, 403501, India

Location

Related Publications (2)

• Singla DR, Shinde S, Patton G, Patel V. The Mediating Effect of School Climate on Adolescent Mental Health: Findings From a Randomized Controlled Trial of a School-Wide Intervention. J Adolesc Health. 2021 Jul;69(1):90-99. doi: 10.1016/j.jadohealth.2020.09.030. Epub 2020 Oct 28.

  PMID: 33127241 DERIVED

• Shinde S, Weiss HA, Varghese B, Khandeparkar P, Pereira B, Sharma A, Gupta R, Ross DA, Patton G, Patel V. Promoting school climate and health outcomes with the SEHER multi-component secondary school intervention in Bihar, India: a cluster-randomised controlled trial. Lancet. 2018 Dec 8;392(10163):2465-2477. doi: 10.1016/S0140-6736(18)31615-5. Epub 2018 Nov 22.

  PMID: 30473365 DERIVED

Study Officials

• Vikram Patel, FMedSci

  London School of Hygiene and Tropical Medicine, UK; and Sangath

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 29, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 11, 2020

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)