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

April 19, 2022 updated by: Sangath

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • DL
      • Goa, DL, India, 110067
        • Sangath

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
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.
Behavioral: POD Adventures

Participants in the intervention arm will receive information about local services/national helplines and a brief problem-solving intervention that is delivered through a smartphone app with telephone guidance from a lay counsellor. The intervention is grounded in stress-coping theory, with a technical focus on practical problem solving. The emphasis on problem solving reflects the primacy of psychosocial stressors in adolescent help-seeking. Moreover, problem-solving is among the most commonly used practice elements in evidence-based psychological interventions for children and adolescents globally.

The content of the app comprises two sections: 'Adventures' which teaches problem-solving concepts and methods through contextually-appropriate games; and 'My POD' which scaffolds the student through the application of step-by-step problem-solving procedures to their own prioritized problems.
No Intervention: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Youth Top Problems (YTP)
Time Frame: 6 weeks
The Youth Top Problems (YTP) is a youth-reported idiographic measure of psychosocial problems that identifies, prioritizes and scores adolescents' three main concerns. Each of the nominated concerns is scored from 0 (not a problem) to 10 (huge problem). A mean severity score can be calculated across the nominated problems. It has been translated and used in previous PRIDE studies in consultation with one of the original developers of the measure (Prof. Bruce Chorpita, UCLA).
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revised Child Anxiety and Depression Scale - Short Version (RCADS-25)
Time Frame: 6 weeks
This is a 25-item questionnaire that assesses for DSM-IV (APA, 2000) related anxiety and depression dimensions in children and adolescents. The measure asks youth to rate how often they experience each item (e.g. "worries that something bad will happen to me") on a 4-point Likert scale ranging from 0 (never) to 3 (always). The RCADS produces a Total Anxiety Scale, which is a sum of five subscales: Generalized Anxiety Disorder, Separation Anxiety Disorder, Social Phobia, Panic Disorder, and Obsessive-Compulsive Disorder. A sixth subscale, Major Depressive Disorder, asks about depressive symptoms. The measure has been used with adolescents in a large number of international studies, including in India (Piqueras 2017, Haldar 2016).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sangath

Collaborators

Harvard Medical School (HMS and HSDM)
London School of Hygiene and Tropical Medicine
University of Sussex

Investigators

  • Study Director: Daniel Michelson, PhD, University of Sussex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2021

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

December 9, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PG_2020_69
  • 106919/Z/15/Z (Other Grant/Funding Number: Wellcome Trust)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

See below.

IPD Sharing Time Frame

12 months after completion of the study

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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