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

NCT04672486 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-04-20

No results posted yet for this study

Summary

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.

Conditions

  • Mental Health Issue
  • Depression, Anxiety
  • Stress

Interventions

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.

Sponsors & Collaborators

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER
  • University of Sussex

    collaborator OTHER
  • London School of Hygiene and Tropical Medicine

    collaborator OTHER
  • Sangath

    lead OTHER

Principal Investigators

  • Vikram Patel, PhD · Harvard Medical School (HMS and HSDM)

  • Daniel Michelson, PhD · University of Sussex

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-28
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • India

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04672486 on ClinicalTrials.gov