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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672486
• Other study ID #: PG_2020_69
• Secondary ID: 106919/Z/15/Z
• Status: Completed
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: April 2022
• Source: Sangath
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Mental Health Issue
• Stress

Intervention

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.

Locations

Country	Name	City	State
India	Sangath	Goa	DL

Sponsors (4)

Lead Sponsor	Collaborator
Sangath	Harvard Medical School (HMS and HSDM), London School of Hygiene and Tropical Medicine, University of Sussex

Country where clinical trial is conducted

India, 

References & Publications (6)

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. Erratum in: Lancet Child Adolesc Health. 2020 Jul 23;:. — View Citation

Piqueras JA, Martín-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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Revised Child Anxiety and Depression Scale - Short Version (RCADS-25)	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