Clinical trial NCT05290142: Pre-and-post Study With a Nested Randomized Trial of Digital Training to Teach Problem-solving Counselling in India
Official title: A Pre-and-post Study With a Nested Randomised Controlled Trial of Coach Versus Self-guided Digital Training in a Youth-focused Problem-solving Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Keywords: digital training
mental health intervention
adolescent mental health
non-specialists
Lead sponsor: Sangath
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: London School of Hygiene and Tropical Medicine
First posted: 2022-03-22
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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. 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knowledge quiz
timeFrame: Change from Baseline Knowledge-based Competency at 6 weeks post randomisation
Secondary outcomes:
measure: MUSIC
timeFrame: 6 weeks post randomisation
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Al-Falah University
state: Delhi
city: New Delhi
country: India
facility: Agragami India
state: Delhi
city: New Delhi
country: India
facility: Youth for Mental Health
state: Delhi
city: Bangalore
country: India
facility: Acharya Institue
state: Karnataka
city: Mumbai
country: India
facility: Maniben Nanavati Women's College
state: Maharashtra
city: Mumbai
country: India
facility: Ballygunj Society for Children in Pain
state: Maharashtra
city: Ghaziabad
country: India
facility: Christ University
state: Uttar Pradesh
city: Noida
country: India
facility: YP Foundation
state: Uttar Pradesh
city: New Delhi
country: India
facility: World Health Partners
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Vikram Patel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.