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

NCT05290142 | Completed DMC

• 2 other identifiers: VP_2015_017106919/Z/15/Z
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 9

Brief Summary

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. 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. 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. 3.Evaluate the processes affecting the implementation of training interventions in both arms

Conditions

Depression, Anxiety

Keywords

digital training; mental health intervention; adolescent mental health; non-specialists

Outcome Measures

Primary Outcomes (1)

• Knowledge quiz

  The primary outcome is a knowledge-based competency measure that incorporates an 17-item multiple-choice quiz (MCQ), with questions related to case-based vignettes that will be administered through the REDCap platform. Parallel forms of the quiz will be used at baseline and endline assessments, the sequencing of which will be determined at random. The assessment format and topic domains have been informed by previous research on competency assessments for nonspecialists (Asher et al., 2021; Ottman, Kohrt, Pedersen \& Schafer, 2020; Pedersen et al., 2021; Kohrt et al. 2015a; Kohrt et al. 2015b, Kohrt et al. 2020). The measure includes questions related to psychotherapies generally as well as specific problem-solving competencies.). Prior to unblinding the dataset, we will carry out a psychometric analysis of MCQ item scores across the entire sample. Poorly performing items may be removed and the primary outcome analysis will be conducted using retained items.

  Change from Baseline Knowledge-based Competency at 6 weeks post randomisation

Secondary Outcomes (1)

• MUSIC

  6 weeks post randomisation

Study Arms (2)

Self-Guided Digital Training (DT)

ACTIVE COMPARATOR

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.

Other: Self-Guided Digital Training

Digital Training with Coaching (DT-C)

EXPERIMENTAL

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.

Other: Digital Training with Coaching (DT-C)

Interventions

Digital Training with Coaching (DT-C) 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.

Digital Training with Coaching (DT-C)

Self-Guided Digital Training 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.

Self-Guided Digital Training (DT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior practice-based education and/or training in psychotherapy or mental health interventions.

Sponsors & Collaborators

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

Study Sites (9)

Acharya Institue

Bangalore, Karnataka, 560107, India

Location

Maniben Nanavati Women's College

Mumbai, Maharashtra, 110024, India

Location

Ballygunj Society for Children in Pain

Mumbai, Maharashtra, 400104, India

Location

Al-Falah University

New Delhi, National Capital Territory of Delhi, 110025, India

Location

Agragami India

New Delhi, National Capital Territory of Delhi, 110076, India

Location

Youth for Mental Health

New Delhi, National Capital Territory of Delhi, 110092, India

Location

Christ University

Ghaziabad, Uttar Pradesh, 201003, India

Location

YP Foundation

Noida, Uttar Pradesh, 201301, India

Location

World Health Partners

New Delhi, 110074, India

Location

Related Publications (9)

• 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.

  PMID: 32585185 BACKGROUND

• 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.

  PMID: 33630893 BACKGROUND

• 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.

  PMID: 31902517 BACKGROUND

• 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.

  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.

  PMID: 25847276 BACKGROUND

• 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.

  PMID: 28593049 BACKGROUND

• 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.

  PMID: 31922690 BACKGROUND

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

  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.

  PMID: 37310781 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Vikram Patel, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Investigator, Outcomes Assessor). Participants will not be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 22, 2022
• Study Start: April 6, 2022
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-05

Data Sharing

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

Locations

IN (9)