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

NCT04672486 | Completed DMC

• 2 other identifiers: PG_2020_69106919/Z/15/Z
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

digital mental health intervention; adolescent mental health

Outcome Measures

Primary Outcomes (1)

• Youth Top Problems (YTP)

  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 Outcomes (1)

• Revised Child Anxiety and Depression Scale - Short Version (RCADS-25)

  6 weeks

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

POD Adventures BEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

• Age: 13 Years - 19 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sangath: lead
• Harvard Medical School (HMS and HSDM): collaborator
• University of Sussex: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

Sangath

Goa, National Capital Territory of Delhi, 110067, India

Location

Related Publications (7)

• Michelson D, Malik K, Krishna M, Sharma R, Mathur S, Bhat B, Parikh R, Roy K, Joshi A, Sahu R, Chilhate B, Boustani M, Cuijpers P, Chorpita B, Fairburn CG, Patel V. Development of a transdiagnostic, low-intensity, psychological intervention for common adolescent mental health problems in Indian secondary schools. Behav Res Ther. 2020 Jul;130:103439. doi: 10.1016/j.brat.2019.103439. Epub 2019 Jul 30.

  PMID: 31466693 BACKGROUND

• Gonsalves PP, Hodgson ES, Kumar A, Aurora T, Chandak Y, Sharma R, Michelson D, Patel V. Design and Development of the "POD Adventures" Smartphone Game: A Blended Problem-Solving Intervention for Adolescent Mental Health in India. Front Public Health. 2019 Aug 23;7:238. doi: 10.3389/fpubh.2019.00238. eCollection 2019.

  PMID: 31508404 BACKGROUND

• Gonsalves PP, Hodgson ES, Bhat B, Sharma R, Jambhale A, Michelson D, Patel V. App-based guided problem-solving intervention for adolescent mental health: a pilot cohort study in Indian schools. Evid Based Ment Health. 2021 Feb;24(1):11-18. doi: 10.1136/ebmental-2020-300194. Epub 2020 Nov 18.

  PMID: 33208507 BACKGROUND

• 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.

  PMID: 32585185 BACKGROUND

• Piqueras JA, Martin-Vivar M, Sandin B, San Luis C, Pineda D. The Revised Child Anxiety and Depression Scale: A systematic review and reliability generalization meta-analysis. J Affect Disord. 2017 Aug 15;218:153-169. doi: 10.1016/j.jad.2017.04.022. Epub 2017 Apr 20.

  PMID: 28475961 BACKGROUND

• Haldar, Kasturi. (2016). Adapting a Revised Child Anxiety and Depression Scale for rural India: a pilot, amenable to scale up. DoI: 10.31234/osf.io/25pnr.

  BACKGROUND

• Gonsalves PP, Sharma R, Hodgson E, Bhat B, Jambhale A, Weiss HA, Fairburn CG, Cavanagh K, Cuijpers P, Michelson D, Patel V. A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2021 Oct 6;10(10):e30339. doi: 10.2196/30339.

  PMID: 34586075 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Vikram Patel, PhD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

• Daniel Michelson, PhD

  University of Sussex

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-arm, individually randomized controlled trial with equal allocation of participants between arms.

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: January 28, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after completion of the study
• 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.

Locations

IN (1)