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

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ClinicalTrials.gov Identifier: NCT03633916
Recruitment Status : Completed
First Posted : August 16, 2018
Last Update Posted : July 19, 2019
Sponsor:
Collaborators:
Harvard Medical School
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Sangath

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.

Condition or disease Intervention/treatment Phase
Help-Seeking Behavior Behavioral: Classroom sensitization session Behavioral: School-level sensitization activities Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 835 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Stepped-wedge cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of a Classroom-based Sensitization Intervention on Demand for Mental Health Care Among School-going Adolescents in New Delhi, India: Study Protocol for a Stepped-wedge Cluster Randomized Controlled Trial
Actual Study Start Date : August 20, 2018
Actual Primary Completion Date : December 15, 2018
Actual Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Intervention
Classroom sensitization session (plus school-level sensitization activities)
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.

Active Comparator: Control
School-level sensitization activities only
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.




Primary Outcome Measures :
  1. Referral rate into the host trial [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Eligibility rate [ Time Frame: 4 weeks ]
    Eligibility rate is defined as the proportion of referred participants meeting eligibility criteria for the host trial, as a function of the number of referred adolescents in a given condition. Host trial eligibility criteria are as follows: (i) Total Difficulties score on the adolescent-reported Strengths and Difficulties Questionnaire (SDQ; Goodman et al, 2000) >/= 19 for boys & >/= 20 for girls; (ii) SDQ Impact Supplement score of >/=2; and (iii) chronicity of mental health problems for >/= 1 month. Referred students will complete the SDQ as part of the host trial's screening assessment, within 7 working days of the referral date. Eligibility rate will be calculated for each of the 4-week time periods and reported for the entire study duration of 12 weeks.

  2. Self-referral rate [ Time Frame: 4 weeks ]
    Self-referral rate is defined as the proportion of referrals which are self-initiated as a function of the number of referred adolescents in a given condition. Self-referral rate will be calculated for each of the 4-week time periods and reported for the entire study duration of 12 weeks, based on data from researchers' referral logs


Other Outcome Measures:
  1. Severity of mental health symptoms [ Time Frame: 4 weeks ]
    Severity of mental health symptoms will be assessed as an exploratory outcome for students referred across the control and intervention conditions. The SDQ total difficulties score will be used to assess the severity of mental health symptoms. It is calculated by adding the scores of all the SDQ sub-scales except the pro-social scale.

  2. Severity of symptom subtypes [ Time Frame: 4 weeks ]
    Internalizing and externalizing symptom subtypes will be assessed as an exploratory outcome for the students referred across the control and intervention conditions. The externalising symptoms score is calculated as the sum of the conduct and hyperactivity sub-scales. The internalising symptoms score is calculated as the sum of the emotional and peer relationship problem sub-scales.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

CLASSROOM CLUSTERS

Inclusion criteria:

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

Exclusion criteria:

  • Classes that have received classroom sensitization sessions during earlier pilot work.

ADOLESCENT PARTICIPANTS

Inclusion criteria:

  • 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

Exclusion criteria:

  • Adolescent not proficient in written and spoken Hindi, as needed to participate fully in study procedures
  • Adolescent needing urgent medical or mental health care

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): NCT03633916


Locations
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India
Sangath
New Delhi, Delhi, India, 110016
Sponsors and Collaborators
Sangath
Harvard Medical School
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Vikram Patel, MRCPsych PhD Harvard Medical School
  Study Documents (Full-Text)

Documents provided by Sangath:
Statistical Analysis Plan  [PDF] July 3, 2019


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sangath
ClinicalTrials.gov Identifier: NCT03633916     History of Changes
Other Study ID Numbers: SANPRIDE_003
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymised individual participant data along with data dictionaries will be shared with other researchers after 12 months of completion of the trial. Data pertaining to the interventions received and outcomes will be shared upon reasonable requests made to the PI and in accordance with the guidelines of the sponsor, collaborating institutions and funder of the study.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.
URL: http://datacompass.lshtm.ac.uk/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sangath:
adolescents
urban
school
demand for mental health care