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

NCT02907125 | Completed DMC

• 1 other identifier: SANSEHER2016_0001
• Study Type: interventional
• Target: 29,527
• Locations: 1 country
• Sites: 1

Brief Summary

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).

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)

• Self-reported bully behaviour

  Up to 7 months

• self-reported 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)

• Self-reported substance use

  Up to 7 months

• Self-reported sexual behaviour

  Up to 7 months

• Self-reported suicide attempts

  Up to 7 months

Study Arms (3)

TSM arm

EXPERIMENTAL

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; Behavioral: Tarang AEP

SM arm

EXPERIMENTAL

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; Behavioral: Tarang AEP

Comparison arm Tarang AEP

ACTIVE COMPARATOR

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

Interventions

SEHER Intervention delivered by TSM BEHAVIORAL

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.

Also known as: TSM Arm

TSM arm

SEHER Intervention delivered by SM BEHAVIORAL

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.

Also known as: SM arm

SM arm

Tarang AEP BEHAVIORAL

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: Comparison arm

Comparison arm Tarang AEP; 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:

• 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.

You may not qualify if:

• None

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 (1)

• Shinde S, Weiss HA, Khandeparkar P, Pereira B, Sharma A, Gupta R, Ross DA, Patton G, Patel V. A multicomponent secondary school health promotion intervention and adolescent health: An extension of the SEHER cluster randomised controlled trial in Bihar, India. PLoS Med. 2020 Feb 11;17(2):e1003021. doi: 10.1371/journal.pmed.1003021. eCollection 2020 Feb.

  PMID: 32045409 DERIVED

Study Officials

• Vikram Patel, FMedSci

  London School of Hygiene and Tropical Medicine

  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: September 15, 2016
• First Posted: September 20, 2016
• Study Start: June 15, 2016
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: December 10, 2020

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)