PRIDE - Pilot Trial of an Online Digital Problem-solving Intervention for School-going Adolescents in Goa, India

Sangath

Status: Completed

Conditions: Depression, Anxiety; Mental Health Issue; Stress

Treatments: Behavioral: POD Adventures

Study type: Interventional

Funder types: Other

Identifiers

NCT04672486

PG_2020_69

106919/Z/15/Z (Other Grant/Funding Number)

Details and patient eligibility

About

This study is part of a Wellcome Trust-funded research programme in India called PRIDE (PRemIum for aDolEscents, 2016-2022) led by Principal Investigator Prof. Vikram Patel (Harvard Medical School). The programme aims to develop and evaluate a trans-diagnostic, stepped-care intervention targeting common mental health problems in school-going adolescents in India.

The study is planned in the context of school closures and other COVID-19 mitigation strategies in India. We will undertake a pilot randomized controlled trial with the specific aims to

• assess the acceptability and feasibility of an online problem-solving intervention
• obtain effect size estimates for the online problem-solving intervention when compared to a usual care control condition
• assess process variables related to intervention and research procedures and thereby assist with planning for a future large-scale trial.

Full description

BACKGROUND:

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. 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. It builds upon India's national initiative for adolescent health, launched in 2014, which emphasises mental health as a public health priority and schools as an important platform for youth-focused treatment delivery.

The development of the PRIDE school-based intervention model has been founded on the principle of stepped care which reserves increasingly specialised, resource-intensive interventions for individuals who do not respond to simpler first-line treatments. Previous PRIDE studies (Parikh 2019, Michelson 2019, Michelson 2020) revealed a high demand for school-based psychological support among socially disadvantaged adolescents. A majority of these adolescents do not meet conventional clinical thresholds for mental disorder, but may still benefit from early intervention to mitigate risks for developing more severe and socially disabling mental health problems in the longer-term.

Hence, the aim of the current study is to evaluate the effectiveness of an online 'open-access' digital intervention for adolescents who have a felt need for psychological support irrespective of assessed psychopathology. Online delivery is necessary due to prevailing COVID-19 restrictions that include school closures and a shift to online schooling for the remainder of the academic year.

SIGNIFICANCE:

This study comprises one of the first online adolescent mental health trials in the context of the COVID-19 outbreak in India. The study will take an existing digital mental health intervention developed and evaluated by our group in India and repurpose this platform for online delivery.

Problem solving was selected as the core intervention component based on global evidence for its generalised (i.e., transdiagnostic) benefits across diverse mental health presentations and its specific relevance to common stressors observed in the target population.

The findings are likely to be generalisable to routine settings since the research will be implemented in government-aided secondary schools which cater to low-income communities. External validity will be further strengthened through idiographic outcome assessment alongside standardised assessment instruments, and broad eligibility criteria which do not exclude any specific mental health presentations.

Enrollment: 11 patients

Sex: All

Ages: 13 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Enrolled as a student in grades 9-12 (ages 13-19 years) at one of the collaborating schools;
• Able to access an Android smartphone with internet and a valid phone number for the six-week duration of the study;
• Wanting psychological help for managing stressful situations or internal states;
• Proficient in written and spoken English, as needed to participate fully in study procedures;
• For adolescents under 18 years of age, provides informed assent to participate, supported by parental consent;
• For adolescents 18 years of age or over, provides informed consent to participate.

Exclusion criteria

• Unable to understand intervention materials (for example, due to a reading or hearing disability or inability to comprehend Hindi, Konkani, or English).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Participants will be offered an online problem-solving intervention that is delivered through a smartphone app (called POD Adventures) with telephone-based guidance from a lay counsellor. The app teaches problem-solving skills through interactive animated vignettes and personalized action plans, with encouraging prompts and feedback offered through an in-app guide character. In addition, methods of gamification are used to model and practice complementary coping strategies (e.g., relaxation) and enhance engagement. Participants will use the app remotely (i.e., from their home) in their own time.

Treatment:

Behavioral: POD Adventures

Usual Care

No Intervention group

Description:

Participants randomized to the control arm will be provided with usual care. This will consist of information and contact details about local mental health service providers and two recently established government provided/affiliated helplines: (i) Manodarpan, a student mental health helpline supported by the Ministry of Human Resource Development; and (ii) a 24/7 mental health helpline (KIRAN) supported by the Social Justice and Empowerment Ministry. The same information will be provided to participants in the intervention arm.