An interventional study of Digital Training with Coaching (DT-C) and Self-Guided Digital Training in Depression, Anxiety, sponsored by Sangath. Completed at 9 sites in India. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Sangath · Not applicable, Interventional, and Other
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:
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.
Exclusion Criteria:
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
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)
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.
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.
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.
Time frame: Change from Baseline Knowledge-based Competency at 6 weeks post randomisation
MUSIC
This will be assessed post-training only. We will use a 26-item questionnaire adapted from MUSIC (eMpowerment, Usefulness, Success, Interest, Caring), an established measure of satisfaction with educational programs that has previously been used in the study setting (Jones, 2017). Items on the questionnaire cover the feasibility, acceptability, adoption and appropriateness of the training program. These are rated on 6 point likert scale ranging from Strongly Agree to Strongly Disagree. The purpose is to identify strengths and weaknesses related to course content that may influence participants' engagement and thus to inform improvements.
Time frame: 6 weeks post randomisation
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Plan to Share IPD: Anonymised participant data, data dictionary and case report forms will be made available 12 months after study completion. Data will be shared after approval by the corresponding author, following a reasonable submitted request. The study protocol and statistical analysis plan are publicly available.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sangath