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

NCT03633916 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 835

Last updated 2019-07-19

No results posted yet for this study

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

Interventions

BEHAVIORAL

Classroom sensitization session

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.

BEHAVIORAL

School-level sensitization activities

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.

Sponsors & Collaborators

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER
  • London School of Hygiene and Tropical Medicine

    collaborator OTHER
  • Sangath

    lead OTHER

Principal Investigators

  • Vikram Patel, MRCPsych PhD · Harvard Medical School (HMS and HSDM)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
13 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2018-12-15
Completion
2018-12-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03633916 on ClinicalTrials.gov