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Trial record 55 of 89 for:    emotional | Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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 : Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Collaborators:
Harvard Medical School
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Vikram Patel, Sangath

Brief Summary:

The trial will evaluate the impact of a one-off classroom-level information and engagement session conducted by a 'lay' counselor as compared to school-level sensitization activities on the demand for school counselling program among adolescents in government-run secondary schools in New Delhi, India. In addition, proportion of such referrals eligible to receive counselling, range in the severity of total symptoms and symptom sub-types would be assessed.

The primary hypothesis is that as compared to school-level sensitization activities, the addition of a one-off classroom-level information and engagement session conducted by a counselor will significantly increase the incidence of referred adolescents to a school counselling service in 4 weeks after the sensitization.

The secondary hypotheses are:

  • Proportion of referrals eligible to receive counselling will be greater in the classes which have received the classroom sensitization component.
  • There will be a greater range in the severity of total symptoms and symptom sub-types among referred students who have been exposed to the classroom sensitization session.
  • A greater number of referrals will be self-referrals from the classrooms that have received the sensitization session.

The trial design is stepped wedge cluster randomized controlled trial with classrooms as clusters. One hundred classrooms would be randomized to receive the classroom session in one of the two specific time periods. Data would be collected on incidence of referrals and on symptom severity as measured by Strengths and Difficulties Questionnaire.

Intention to treat analysis would be conducted using both cluster-level summaries and individual-level data and using generalized estimating equations to account for the effect of clustering and time during analysis. Secondary analysis for 'as treated' and sub-group analysis for self-referred cases would also be conducted.

This trial is a part of a large research program - Premium for adolescents and nested within the recruitment period of a larger trial to evaluate school-based problem solving counseling intervention for addressing common mental health problems among adolescents.


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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Stepped Wedge Cluster Randomised Controlled Trial (SW-CRCT), complete design.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluating Classroom-based Sensitization Intervention on Increasing the Demand for Mental Health Care Among School-going Adolescents in New Delhi, India: Study Protocol for a Stepped-wedge Cluster Randomized Controlled Trial
Estimated Study Start Date : August 20, 2018
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Classroom sensitization session

The experimental intervention is a one-off classroom information and engagement session delivered in addition to school-level sensitization activities. Individual classroom sessions will be conducted by a 'lay' counselor with facilitatory support from a researcher.

Each session will be conducted with the aid of a video with an aim of providing information to adolescents about common mental health problems, self-care and availability of a school counselling service. The session will be conducted during a class period lasting about 30 minutes. A brief self-screening form will be further distributed in the class for the use of the students and encourage the self-referral to the school counselling program.

This will be implemented in the classes from the same schools already receiving the school level sensitization activities.

Other: Classroom information and engagement session
The classroom information and engagement session will be conducted to provide age-appropriate information about the causes, impacts and ways of coping with common mental health difficulties, during a class period lasting about 30 minutes. In order to make the session more engaging for students, a video was developed. A short video intervention is accessible, easy to disseminate and appealing to students. The purposes of the video are as following: advertising the availability of support, eliciting eligible referrals, and increasing mental health literacy among the student population. The video includes common mental health messages given to students during school programs and is tailored to the student population that we are working with. The video is 2.5 minutes long and is intended for use with students in classes 8-12, aged 14-19 years. A Flipchart was also developed for those cases, where due to logistical constraints, the video cannot be screened.

Other: School level sensitization activities
The school level sensitization activities will be implemented for the entire school. The posters would target student and parents with information about the school counselling program and referral pathways in an easy and readable format. The drop-box for student self-referral slips, set up in a prominent place with a poster/ short instruction to use the drop-box. A series of meetings with teachers teaching the 9th, 10th, 11th and 12th classes will be conducted in groups of 8-12. Each meeting will last for 30-40 minutes, focusing on common mental health problems among adolescents and the objectives, eligibility criteria, delivery methods and referral process of the school counselling service. Finally, support of the school Principal would be sought through a separate meeting.

Active Comparator: School level sensitization activities

The control arm intervention will comprise sensitization activities conducted at the whole school level. These activities will include:

  1. Display of posters targeting student and parents with information about the school counselling program and referral pathways in an easy and readable format.
  2. A drop-box for student self-referral slips, set up in a prominent place (Preferably outside the counsellor's room or in a main hallway).
  3. A series of meetings with school teachers will be conducted by the counsellor at the beginning of the trial.
  4. A meeting with the school principal will be conducted by the Intervention Coordinators at the beginning of the trial.
Other: School level sensitization activities
The school level sensitization activities will be implemented for the entire school. The posters would target student and parents with information about the school counselling program and referral pathways in an easy and readable format. The drop-box for student self-referral slips, set up in a prominent place with a poster/ short instruction to use the drop-box. A series of meetings with teachers teaching the 9th, 10th, 11th and 12th classes will be conducted in groups of 8-12. Each meeting will last for 30-40 minutes, focusing on common mental health problems among adolescents and the objectives, eligibility criteria, delivery methods and referral process of the school counselling service. Finally, support of the school Principal would be sought through a separate meeting.




Primary Outcome Measures :
  1. Incidence of referrals [ Time Frame: For 4 weeks; up to 12 weeks ]
    The incidence of referred adolescents for the PRIDE counselling service collected for every 4 week time period across the two arms for the entire duration of the trial. The referrals are recorded in the referral process log.


Secondary Outcome Measures :
  1. Case rate [ Time Frame: For 4 weeks; up to 12 weeks ]

    The Strengths and Difficulties Questionnaire (SDQ) is a 25-item self-report measure of youth mental health difficulties (Goodman et al., 2000). A Total Difficulties score is derived by summing items from four problem subscales (Emotional, Conduct, hyperactivity/inattention, and Peer problems). The measure is the most widely used clinical and research instrument in the field of child and adolescent mental health globally. The Hindi version will be used in complementary forms for self-report by adolescents and parents. The adolescent-reported Total Difficulties score will be a co-primary outcome, while the parent-reported Total Difficulties score will be a secondary outcome.

    Cases are defined as individuals meeting all the following eligibility criteria 1) Strengths and Difficulties Questionnaire (SDQ) >/= 19 for boys & >/= 20 for girls, SDQ impact supplement score of >/=2, 3) chronicity of mental health problems for >/= 1 month.


  2. Severity of mental health symptoms [ Time Frame: For 4 weeks; up to 12 weeks ]
    Total score obtained by the referred students on the Strengths and Difficulties Questionnaire and compared across the two arms.

  3. Severity of symptom types [ Time Frame: For 4 weeks; up to 12 weeks ]
    Severity of symptom types would be based on the actual scores of the sub-scales of the Strength and Difficulties Questionnaire obtained by the referred students across the two arms

  4. Referral patterns [ Time Frame: For 4 weeks; up to 12 weeks ]
    Proportion of all referrals which are self-initiated or parent- or teacher-initiated; and proportion of the self-initiated referrals that are made through the drop-box and using the self-screening form across the two arms



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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:

    1. Classes across the class standards of 9th, 10th, 11th and 12th in the six participating schools.

  • Exclusion criteria:

    1. Classes that have received information and engagement session in the pilot work in July 2018.

Adolescent participants:

  • Inclusion criteria:

    1. Enrolled as a student in Class 9-12 (ages 13-20 years) at one of the collaborating secondary schools
    2. Adolescents willing and able to consent for participation in the research and specifically for using the process data and the scores of the Strengths and Difficulties Questionnaire administered to determine eligibility for analysis.
  • Exclusion criteria:

    1. Adolescents are not proficient in written and spoken Hindi, as needed to participate fully in study procedure.
    2. Adolescents needing urgent medical attention.

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


Contacts
Contact: Rachana Parikh, MPH +91 9210773724 rachana.parikh@sangath.in

Sponsors and Collaborators
Sangath
Harvard Medical School
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Vikram Patel, MRCPsych PhD Harvard Medical School

Publications:

Responsible Party: Vikram Patel, Professor, Harvard T.H. Chan School of Public Health, USA, 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: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vikram Patel, Sangath:
adolescents
urban
school
demand for mental health care