Pre-and-post Study With a Nested Randomized Trial of Digital Training to Teach Problem-solving Counselling in India

NCT ID: NCT05290142

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

277 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-06

Study Completion Date

2022-08-16

Brief Summary

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This study is part of a Wellcome Trust-funded research program in India called PRIDE (PRemIum for aDolEscents, 2016-2022) led by Principal Investigator Prof. Vikram Patel (Harvard Medical School). The goal of PRIDE is to establish a suite of scalable psychosocial interventions for common adolescent mental health problems in India.

Following on from earlier studies to develop and evaluate the various PRIDE interventions in school settings, the current study aims to generate evidence on methods to support implementation. We will undertake a pre-and-post study design with a nested randomized controlled trial with the specific aims to:

1. Evaluate the effects of digital training on non-specialists' competency to deliver an evidence-based problem-solving intervention for common adolescent mental health problems
2. Evaluate the incremental effect of digital training with coaching (DT-C) in comparison with self-guided digital training (DT) on non-specialists' competency to deliver an evidence-based problem-solving intervention for common adolescent mental health problems
3. Evaluate the processes affecting the implementation of training interventions in both arms

Detailed Description

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PRIDE has been implemented in India to address the scarcity of evidence- based interventions for common adolescent mental health problems nationally and in low-resource settings more widely (Michelson et al., 2020). The goal is to develop and evaluate a suite of scalable, transdiagnostic psychological interventions (i.e., suitable for a variety of mental health presentations) that can be delivered by non-specialist ('lay') counsellors in resource-poor school settings.

There is a major knowledge gap concerning how to build capacity outside of specialist health settings and how to motivate and support non-specialists through structured capacity building activities in absence of adequate specialist trainers.

Hence, the aim of the current study is to evaluate the effectiveness of a digital training for non-specialists to improve their competency in delivering an evidence-based adolescent mental health intervention.

SIGNIFICANCE:

The health care system in India faces a number of key challenges: (1) poor quality and inadequately resourced primary health care; (2) low numbers and unequally distributed skilled human resources; (3) a large, unregulated, private sector; (4) low public spending on health leading to high levels of out of pocket expenditure; (5) fragmented health information systems; (6) irrational use and spiralling costs of drugs and technology; and (7) weak governance and accountability.

The current study will address the dearth of evidence on workforce development strategies necessary to scale-up evidence-based adolescent mental health interventions in low-resource settings.

Conditions

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Depression, Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional Study Model: Digital training intervention: delivered to all participants (pre-and-post comparison) Additional coaching intervention: two-arm, individually randomized controlled trial with parallel assignment
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Double (Investigator, Outcomes Assessor). Participants will not be blinded.

Study Groups

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Self-Guided Digital Training (DT)

Participants will be enrolled in a digital training course that addresses non-specific counselling skills and skills specific to an evidence-based problem-solving intervention. The course will be available online on a smartphone app as well as a website that can be accessed through an internet-enabled device.

Participants will also have an option to message a centralized helpline for assistance with accessing and navigating the digital interface.

Group Type ACTIVE_COMPARATOR

Self-Guided Digital Training

Intervention Type OTHER

Participants will be enrolled in a digital training course that addresses non-specific counselling skills and skills specific to an evidence-based problem-solving intervention. The course will be available offline and online on a smartphone app (called 'Sangath Training') as well as a website (https://training.sangath.in/login/index.php) that can be accessed through an internet-enabled device. The training will be delivered through didactic lectures, role-play demonstrations, and recommended readings spread across 16 modules. Participants will be provided with automated feedback on their learning through self-assessment quizzes after each module. Modules will be available sequentially and unlocked after accessing all content in the preceding module, over a period of 4 weeks. Technical helpline: Participants will also have an option to message a centralized helpline for assistance with accessing and navigating the digital interface.

Digital Training with Coaching (DT-C)

In addition to receiving the same digital training resources as the DT group, participants in DT-C will receive weekly individualized telephone calls from a coach who will motivate them and troubleshoot towards course completion. Participants will also be able to send text messages to coaches.

Group Type EXPERIMENTAL

Digital Training with Coaching (DT-C)

Intervention Type OTHER

An identical digital training course and helpline will be available for the participants in this group. In addition to receiving the same digital training resources as the DT group, participants in DT-C will receive weekly individualized telephone calls from a coach who will motivate them and troubleshoot towards course completion. The focus will be on clarifying learning objectives and redirecting participants to relevant materials rather than providing new learning opportunities. Participants will also be able to send text messages to coaches with queries related to course content, progress and technical difficulties. Coaches will reply to participants' messages within one working day and send reminders about upcoming telephone sessions, as well as prompts if the participant has not logged into the course for 3 consecutive days.

Interventions

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Digital Training with Coaching (DT-C)

An identical digital training course and helpline will be available for the participants in this group. In addition to receiving the same digital training resources as the DT group, participants in DT-C will receive weekly individualized telephone calls from a coach who will motivate them and troubleshoot towards course completion. The focus will be on clarifying learning objectives and redirecting participants to relevant materials rather than providing new learning opportunities. Participants will also be able to send text messages to coaches with queries related to course content, progress and technical difficulties. Coaches will reply to participants' messages within one working day and send reminders about upcoming telephone sessions, as well as prompts if the participant has not logged into the course for 3 consecutive days.

Intervention Type OTHER

Self-Guided Digital Training

Participants will be enrolled in a digital training course that addresses non-specific counselling skills and skills specific to an evidence-based problem-solving intervention. The course will be available offline and online on a smartphone app (called 'Sangath Training') as well as a website (https://training.sangath.in/login/index.php) that can be accessed through an internet-enabled device. The training will be delivered through didactic lectures, role-play demonstrations, and recommended readings spread across 16 modules. Participants will be provided with automated feedback on their learning through self-assessment quizzes after each module. Modules will be available sequentially and unlocked after accessing all content in the preceding module, over a period of 4 weeks. Technical helpline: Participants will also have an option to message a centralized helpline for assistance with accessing and navigating the digital interface.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or above
* Associated with one of the partner organizations/institutes
* Access to an internet-enabled smartphone or computer device
* Provides consent to participate

Exclusion Criteria

* Prior practice-based education and/or training in psychotherapy or mental health interventions.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Sangath

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vikram Patel, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard Medical School (HMS and HSDM)

Locations

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Acharya Institue

Bangalore, Karnataka, India

Site Status

Maniben Nanavati Women's College

Mumbai, Maharashtra, India

Site Status

Ballygunj Society for Children in Pain

Mumbai, Maharashtra, India

Site Status

Al-Falah University

New Delhi, National Capital Territory of Delhi, India

Site Status

Agragami India

New Delhi, National Capital Territory of Delhi, India

Site Status

Youth for Mental Health

New Delhi, National Capital Territory of Delhi, India

Site Status

Christ University

Ghaziabad, Uttar Pradesh, India

Site Status

YP Foundation

Noida, Uttar Pradesh, India

Site Status

World Health Partners

New Delhi, , India

Site Status

Countries

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India

References

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Michelson D, Malik K, Parikh R, Weiss HA, Doyle AM, Bhat B, Sahu R, Chilhate B, Mathur S, Krishna M, Sharma R, Sudhir P, King M, Cuijpers P, Chorpita B, Fairburn CG, Patel V. Effectiveness of a brief lay counsellor-delivered, problem-solving intervention for adolescent mental health problems in urban, low-income schools in India: a randomised controlled trial. Lancet Child Adolesc Health. 2020 Aug;4(8):571-582. doi: 10.1016/S2352-4642(20)30173-5. Epub 2020 Jun 23.

Reference Type BACKGROUND
PMID: 32585185 (View on PubMed)

Asher L, Birhane R, Teferra S, Milkias B, Worku B, Habtamu A, Kohrt BA, Hanlon C. "Like a doctor, like a brother": Achieving competence amongst lay health workers delivering community-based rehabilitation for people with schizophrenia in Ethiopia. PLoS One. 2021 Feb 25;16(2):e0246158. doi: 10.1371/journal.pone.0246158. eCollection 2021.

Reference Type BACKGROUND
PMID: 33630893 (View on PubMed)

Ottman KE, Kohrt BA, Pedersen GA, Schafer A. Use of role plays to assess therapist competency and its association with client outcomes in psychological interventions: A scoping review and competency research agenda. Behav Res Ther. 2020 Jul;130:103531. doi: 10.1016/j.brat.2019.103531. Epub 2019 Dec 14.

Reference Type BACKGROUND
PMID: 31902517 (View on PubMed)

Pedersen, G. A., Gebrekristos, F., Eloul, L., Golden, S., Hemmo, M., Akhtar, A., ... & Kohrt, B. A. (2021). Development of a Tool to Assess Competencies of Problem Management Plus Facilitators Using Observed Standardised Role Plays: The EQUIP Competency Rating Scale for Problem Management Plus. Intervention, 19(1), 107.

Reference Type BACKGROUND

Kohrt BA, Jordans MJ, Rai S, Shrestha P, Luitel NP, Ramaiya MK, Singla DR, Patel V. Therapist competence in global mental health: Development of the ENhancing Assessment of Common Therapeutic factors (ENACT) rating scale. Behav Res Ther. 2015 Jun;69:11-21. doi: 10.1016/j.brat.2015.03.009. Epub 2015 Mar 24.

Reference Type BACKGROUND
PMID: 25847276 (View on PubMed)

Kohrt BA, Ramaiya MK, Rai S, Bhardwaj A, Jordans MJD. Development of a scoring system for non-specialist ratings of clinical competence in global mental health: a qualitative process evaluation of the Enhancing Assessment of Common Therapeutic Factors (ENACT) scale. Glob Ment Health (Camb). 2015;2:e23. doi: 10.1017/gmh.2015.21. Epub 2015 Dec 9.

Reference Type BACKGROUND
PMID: 28593049 (View on PubMed)

Kohrt BA, Schafer A, Willhoite A, Van't Hof E, Pedersen GA, Watts S, Ottman K, Carswell K, van Ommeren M. Ensuring Quality in Psychological Support (WHO EQUIP): developing a competent global workforce. World Psychiatry. 2020 Feb;19(1):115-116. doi: 10.1002/wps.20704. No abstract available.

Reference Type BACKGROUND
PMID: 31922690 (View on PubMed)

Jones, B. D., Li, M., & Cruz, J. M. (2017). A cross-cultural validation of the MUSICĀ® Model of Academic Motivation Inventory: Evidence from Chinese-and Spanish-speaking university students. International Journal of Educational Psychology, 6(1), 25-44.

Reference Type BACKGROUND

Mathur S, Weiss HA, Neuman M, Field AP, Leurent B, Shetty T, J JE, Nair P, Mathews R, Malik K, Michelson D, Patel V. Coach-Supported Versus Self-guided Digital Training Course for a Problem-solving Psychological Intervention for Nonspecialists: Protocol for a Pre-Post Nested Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 13;12:e41981. doi: 10.2196/41981.

Reference Type DERIVED
PMID: 37310781 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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106919/Z/15/Z

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VP_2015_017

Identifier Type: -

Identifier Source: org_study_id

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