Impact of a Classroom-based Sensitization Intervention on Demand for Mental Health Care Among Adolescents in India

NCT03633916 | Completed DMC

• 1 other identifier: SANPRIDE_003
• Study Type: interventional
• Target: 835
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this embedded stepped-wedge, cluster randomized controlled trial is to evaluate the impact of a classroom sensitization (intervention condition), over and above the school-level sensitization activities (control condition), on referrals to a host trial (examining the effectiveness of a problem-solving intervention delivered by lay counsellors). The primary hypothesis is that the classroom-level sensitization intervention will be associated with a higher overall referral rate into the host trial (i.e. the proportion of adolescents referred as a function of the total sampling frame in each condition). The secondary hypotheses are that, compared with the control condition, the intervention condition will be associated with a greater proportion of referred students who meet eligibility criteria for inclusion in the host trial and a greater proportion of students who self-refer. We will also explore whether there are any differences between conditions in terms of the severity of total symptoms and symptom subtypes presented by referred adolescents.

Conditions

Help-Seeking Behavior

Keywords

adolescents; urban; school; demand for mental health care

Outcome Measures

Primary Outcomes (1)

• Referral rate into the host trial

  The referral rate will be calculated as the number of referred students from a given condition divided by the total number of students in corresponding classes. This will be calculated from researchers' referral logs. Referrals will be recorded continuously and reported for each 4 weeks' time period, for the total study duration of 12 weeks.

  4 weeks

Secondary Outcomes (2)

• Eligibility rate

  4 weeks

• Self-referral rate

  4 weeks

Other Outcomes (2)

• Severity of mental health symptoms

  4 weeks

• Severity of symptom subtypes

  4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Classroom sensitization session (plus school-level sensitization activities)

Behavioral: Classroom sensitization session; Behavioral: School-level sensitization activities

Control

ACTIVE COMPARATOR

School-level sensitization activities only

Behavioral: School-level sensitization activities

Interventions

Classroom sensitization session BEHAVIORAL

A one-off classroom information and engagement session will be delivered in addition to school-level sensitization activities. Individual classroom sessions will be conducted by a 'lay' counsellor with support from a researcher. The classroom session will start with a short animated video which provides age-appropriate information about types, causes, impacts and ways of coping with common mental health problems. The video will be followed by a guided group discussion, structured around a standardized script that builds on the topics covered in the video. In case of technical difficulties that may prevent the video from being shown, a flipchart based on still illustrations from the video will be used. At the end of the session, students will be handed a self-referral form which includes normalizing information and question-based prompts to assist with self-identification of mental health problems.

Intervention

School-level sensitization activities BEHAVIORAL

The control condition intervention will comprise sensitization activities conducted at the whole school level. These activities will include: 1. Posters containing information about the school counselling program and referral pathways will be displayed in prominent locations at each school. 2. A drop-box for student self-referral slips will be set up in a prominent location at each school. 3. Information meetings with teachers and the principal will be conducted at each school from the beginning of the trial.

Control; Intervention

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Classes from grades 9-12 in the six collaborating schools.

You may not qualify if:

• Classes that have received classroom sensitization sessions during earlier pilot work.
• ADOLESCENT PARTICIPANTS
• Enrolled as a student in grades 9-12 (aged 13-20 years) at one of the collaborating schools
• Adolescent willing and able to consent for participation in the research
• Adolescent not proficient in written and spoken Hindi, as needed to participate fully in study procedures
• Adolescent needing urgent medical or mental health care

Sponsors & Collaborators

• Sangath: lead
• Harvard Medical School (HMS and HSDM): collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Sangath

New Delhi, National Capital Territory of Delhi, 110016, India

Location

Related Publications (10)

• Patton GC, Sawyer SM, Santelli JS, Ross DA, Afifi R, Allen NB, Arora M, Azzopardi P, Baldwin W, Bonell C, Kakuma R, Kennedy E, Mahon J, McGovern T, Mokdad AH, Patel V, Petroni S, Reavley N, Taiwo K, Waldfogel J, Wickremarathne D, Barroso C, Bhutta Z, Fatusi AO, Mattoo A, Diers J, Fang J, Ferguson J, Ssewamala F, Viner RM. Our future: a Lancet commission on adolescent health and wellbeing. Lancet. 2016 Jun 11;387(10036):2423-78. doi: 10.1016/S0140-6736(16)00579-1. Epub 2016 May 9. No abstract available.

  PMID: 27174304 BACKGROUND

• Wei Y, McGrath PJ, Hayden J, Kutcher S. Mental health literacy measures evaluating knowledge, attitudes and help-seeking: a scoping review. BMC Psychiatry. 2015 Nov 17;15:291. doi: 10.1186/s12888-015-0681-9.

  PMID: 26576680 BACKGROUND

• Kutcher S, Wei Y, Costa S, Gusmao R, Skokauskas N, Sourander A. Enhancing mental health literacy in young people. Eur Child Adolesc Psychiatry. 2016 Jun;25(6):567-9. doi: 10.1007/s00787-016-0867-9. No abstract available.

  PMID: 27236662 BACKGROUND

• Wei Y, Hayden JA, Kutcher S, Zygmunt A, McGrath P. The effectiveness of school mental health literacy programs to address knowledge, attitudes and help seeking among youth. Early Interv Psychiatry. 2013 May;7(2):109-21. doi: 10.1111/eip.12010. Epub 2013 Jan 24.

  PMID: 23343220 BACKGROUND

• Goodman R, Ford T, Simmons H, Gatward R, Meltzer H. Using the Strengths and Difficulties Questionnaire (SDQ) to screen for child psychiatric disorders in a community sample. Br J Psychiatry. 2000 Dec;177:534-9. doi: 10.1192/bjp.177.6.534.

  PMID: 11102329 BACKGROUND

• Thompson JA, Davey C, Fielding K, Hargreaves JR, Hayes RJ. Robust analysis of stepped wedge trials using cluster-level summaries within periods. Stat Med. 2018 Jul 20;37(16):2487-2500. doi: 10.1002/sim.7668. Epub 2018 Apr 10.

  PMID: 29635789 BACKGROUND

• Barker D, McElduff P, D'Este C, Campbell MJ. Stepped wedge cluster randomised trials: a review of the statistical methodology used and available. BMC Med Res Methodol. 2016 Jun 6;16:69. doi: 10.1186/s12874-016-0176-5.

  PMID: 27267471 BACKGROUND

• Liang K-Y, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika. 1986;73(1):13-22.

  BACKGROUND

• Parikh R, Hoogendoorn A, Michelson D, Ruwaard J, Sharma R, Bhat B, Malik K, Sahu R, Cuijpers P, Patel V. Increasing demand for school counselling through a lay counsellor-delivered classroom sensitisation intervention: a stepped-wedge cluster randomised controlled trial in New Delhi, India. BMJ Glob Health. 2021 Jun;6(6):e003902. doi: 10.1136/bmjgh-2020-003902.

  PMID: 34172486 DERIVED

• Parikh R, Michelson D, Malik K, Shinde S, Weiss HA, Hoogendoorn A, Ruwaard J, Krishna M, Sharma R, Bhat B, Sahu R, Mathur S, Sudhir P, King M, Cuijpers P, Chorpita BF, Fairburn CG, Patel V. The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial. Trials. 2019 Sep 18;20(1):568. doi: 10.1186/s13063-019-3573-3.

  PMID: 31533783 DERIVED

MeSH Terms

Conditions

Help-Seeking Behavior

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Vikram Patel, MRCPsych PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped-wedge cluster randomized controlled trial

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 16, 2018
• Study Start: August 20, 2018
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after completion of trial.
• Access Criteria: Access to data will be granted to researchers after review of requests by PI and in accordance with the guidelines of the sponsor, collaborating institutions and funder of the study.

Locations

IN (1)