Mental Health IssueNCT04672486
PRIDE - Pilot Trial of an Online Digital Problem-solving Intervention for School-going Adolescents in Goa, India
A study testing POD Adventures in people with Mental Health Issue and Depression, Anxiety, run by Sangath at 1 site in India.
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). Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Depression, Anxiety, Stress
- What is being tested?
- POD Adventures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIndia
- Study dates
- 28 Jan 2021to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Unable to understand intervention materials (for example, due to a reading or hearing disability or inability to comprehend Hindi, Konkani, or English).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mental Health Issue, Depression, Anxiety, Stress
- Being tested
- POD Adventures
- Keywords
- digital mental health intervention, adolescent mental health
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POD AdventuresBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (1)
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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start28 Jan 2021
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm, individually randomized controlled trial with equal allocation of participants between arms.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sangath
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), University of Sussex, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Vikram Patel, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)Daniel Michelson, PhD, Study director, University of Sussex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672486
- Sponsor's protocol ID
- PG_2020_69
- Other IDs
- 106919/Z/15/Z
- Status last verified
- Apr 2022
- First submitted
- 9 Dec 2020
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: See below.
Publications
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.
PubMed 31466693Gonsalves 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.
PubMed 31508404Gonsalves 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.
PubMed 33208507Michelson 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.
PubMed 32585185Piqueras 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.
PubMed 28475961Haldar, 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.
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.
PubMed 34586075
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIDE - Pilot Trial of an Online Digital Problem-solving Intervention for School-going Adolescents in Goa, India
- ClinicalTrials.gov ID
- NCT04672486
- Acronym / sponsor ID
- PG_2020_69
- Conditions
- Mental Health Issue, Depression, Anxiety, Stress
- Keywords
- digital mental health intervention, adolescent mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- SangathUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), University of Sussex, London School of Hygiene and Tropical Medicine
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A two-arm, individually randomized controlled trial with equal allocation of participants between arms.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: POD AdventuresParticipants 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. |
| 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. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Unable to understand intervention materials (for example, due to a reading or hearing disability or inability to comprehend Hindi, Konkani, or English).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POD AdventuresParticipants 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. | Behavioural | Intervention Arm |
Primary outcome
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).
1 secondary outcome
Revised Child Anxiety and Depression Scale - Short Version (RCADS-25)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Background: PubMed 31466693Michelson 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.
- Background: PubMed 31508404Gonsalves 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.
- Background: PubMed 33208507Gonsalves 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.
- Background: PubMed 32585185Michelson 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.
- Background: PubMed 28475961Piqueras 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.
- BackgroundHaldar, 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.
- Derived from this study: PubMed 34586075Gonsalves 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.
- Individual participant dataSharing planned: Yes. See below.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikram Patel, PhD principal investigator
Harvard Medical School (HMS and HSDM)
Daniel Michelson, PhD study director
University of Sussex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POD Adventures in people with Mental Health Issue and Depression, Anxiety, run by Sangath at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth Top Problems (YTP) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04672486, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.