ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12622000858796

Ethics application status

Approved

Date submitted

10/05/2022

Date registered

17/06/2022

Date last updated

5/08/2022

Date data sharing statement initially provided

17/06/2022

Date results provided

17/06/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Process evaluation of a youth resilience intervention in urban North India during the COVID-19 pandemic – a mixed methods study

Scientific title

Process evaluation of a youth resilience intervention in urban North India during the COVID-19 pandemic – a mixed methods study

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

ND - COVID

Linked study record

Nil

Health condition

Health condition(s) or problem(s) studied:

youth mental distress

social exclusion

gender discrimination

poor mental health

Low resilience

Condition category

Condition code

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Nae Disha (New Pathways) is a four month long youth resilience and mental health intervention developed by Burans, a community mental health initiative of the Emmanuel Hospital Association, building on the Ottawa health promotion charter, positive psychology and youth development. It’s been previously implemented amongst out-of-school adolescents in Northern India and studies have demonstrated effectiveness in improving resilience, mental health and social inclusion. Modules covered include; character strengths, building self esteem, standing up to difficult behaviour, coping with tension, sexual and reproductive health, and gender and gender based violence. Each adolescent was given homework to do in the form of a workbook given at the beginning of the first group session. The topics of homework included practical use of the session content facilitated. The homework is completed weekly during the 18 week course and takes around 20-30 minutes to complete. The facilitator follows up on homework at the beginning of each session.

Each session lasts 1.5 hours and was facilitated face to face in groups of 8 to 10 adolescents, once a week over the course of 18 weeks. The intervention was delivered by community health workers trained to facilitate youth groups.

The intervention was monitored through attendance and homework completion registers as well as monitoring visits by coaches and/field supervisors of the intervention.

Intervention code [1]

Prevention

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

mental health scores (PHQ9 and GAD 7)

Timepoint [1]

18 weeks after starting the course (immediately after completion of the 18 modules of Nae Disha)

Primary outcome [2]

resilience scores (CD- RISC 10 )

Timepoint [2]

18 weeks after starting the course (immediately after completion of the 18 modules of Nae Disha)

Secondary outcome [1]

Gender attitudes (GEMS)

Timepoint [1]

18 weeks after starting the course (immediately after completion of the 18 modules of Nae Disha)

Secondary outcome [2]

Self efficacy (Schwarzer's General Self-Efficacy Scale)

Timepoint [2]

18 weeks after starting the course (immediately after completion of the 18 modules of Nae Disha)

Eligibility

Key inclusion criteria

Young people resident in target slums of Dehradun and Selaqui (Sahaspur, Selaqui, Brahmanwala, Kanwali Road, Patel Nagar)
Aged 13 - 18 years
Studying in specific government schools in the target area

Minimum age

13 Years

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Young people not residing in the area for the ensuing 15 weeks.
Young people not belonging to government schools in the target area

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Nil

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Nil

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Pre-post uncontrolled study

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Basic descriptive statistics and t test to determine significant change in mean scores
Qualitative data was analysed for meta-themes, and then inductively, using thematic analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

26/08/2020

Date of last participant enrolment

Anticipated

Actual

12/09/2020

Date of last data collection

Anticipated

Actual

28/02/2022

Sample size

Target

400

Accrual to date

Final

426

Recruitment outside Australia

Country [1]

India

State/province [1]

Uttarakhand

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Herbertpur Christian Hospital

Address [1]

Athan Bagh, Herbertpur, Uttarakhand 248142

Country [1]

India

Primary sponsor type

Individual

Name

Kaaren Mathias

Address

University of Canterbury

20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
NZ

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Pooja S Pillai

Address [1]

Herbertpur Christian Hospital, Athan Bagh, Herbertpur, Uttarakhand 248142

Country [1]

India

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Emmanuel Hospital Association Institutional Ethics Committee

Ethics committee address [1]

808/92 Deepali Building, Nehru place, New Delhi, 110019

Ethics committee country [1]

India

Date submitted for ethics approval [1]

16/03/2020

Approval date [1]

25/08/2020

Ethics approval number [1]

Protocol 224

Summary

Brief summary

Young people are among the groups identified to be at higher risk of anxiety, stress and distress in India, especially if they already experience structural disadvantage. The global COVID-19 pandemic has led to dramatic social restrictions that were introduced to limit spread of COVID-19. Young people confined to their households during lockdowns experience greater risk for mental ill-health during the pandemic with changes in daily routine, increased violence in families and lack of access to peers, teachers and physical activity. Many have lost family members and peers due to COVID-19 infection. Nae Disha (New Pathways – developed by Burans, a community mental health initiative) is a four month long community based youth resilience and mental health intervention evidenced to be effective in reducing anxiety and depression, and improving gender equality attitudes. This study’s aim was to evaluate the implementation processes in conducting Nae Disha in disadvantaged urban communities in North India during the COVID 19 pandemic, while limiting transmission of the SARS-Cov-2 respiratory virus. 
Nae Disha was implemented from September to December 2020, following the first wave of the Indian COVID-19 pandemic, in three urban and peri-urban sites in Uttarakhand, North India, among 426 school-going adolescents from the ages of 13 to 18. A total of 79 people contributed to this process evaluation through individual interviews or focus group discussions. Basic descriptive statistics was used to analyse socio-demographic data using Microsoft Excel.  Interviews and FGDs were recorded, transcribed and translated, and data analysed using thematic analysis. 
The mechanisms supporting implementation are; use of local facilitators, appropriate sequencing of modules and confronting content, and a dynamic and engaging format of session delivery (group sessions with games relevant to topic), specific to the context in the communities. The changing pandemic context required agile changes to implementation, that increased facilitator workload and fatigue. 
This study illustrates the value of psychosocial groups as a platform that is socially feasible, acceptable, and cost-effective, that can improve mental health outcomes through increased social networks, as well as through the opportunity to share strategies and approaches for improved mental health. This process evaluation indicates that the low cost Nae Disha intervention can be facilitated in restricted pandemic settings with dynamic changes to implementation strategy, to reduce virus transmission.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Pooja S Pillai

Address

Herbertpur christian Hospital,
Athan Bagh, Herbertpur, Dehradun, 248142

Country

India

Phone

+917300836960

Fax

[email protected]

Contact person for public queries

Name

Pooja S Pillai

Address

Herbertpur christian Hospital, Athan Bagh,
Herbertpur, Dehradun, 248142

Country

India

Phone

+917300836960

Fax

[email protected]

Contact person for scientific queries

Name

Kaaren Mathias

Address

University of Canterbury, School of health sciences, Arts road, 8041
Christchurch, New Zealand

Country

New Zealand

Phone

+642041497530

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Sensitive data pertaining to mental health status cannot be shared and needs to maintain confidentiality.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
15970	Ethical approval					384027-(Uploaded-08-05-2022-21-31-37)-Study-related document.pdf
16080	Other	Mathias K, Mathias J, Goicolea I, Kermode M. Strengthening community mental health competence—A realist informed case study from Dehradun, North India. Heal Soc Care Community. 2018;26(1):e179–90. Mathias K, Singh P, Butcher N, Grills N, Srinivasan V, Kermode M. Promoting social inclusion for young people affected by psycho-social disability in India – a realist evaluation of a pilot intervention. Glob Public Health [Internet]. 2019 Dec 2;14(12):1718–32. Available from: https://doi.org/10.1080/17441692.2019.1616798 Kermode M, Grills N, Singh P, Mathias K. Improving Social Inclusion for Young People Affected by Mental Illness in Uttarakhand, India. Community Ment Health J. 2020; Mathias K, Pandey A, Armstrong G, Diksha P, Kermode M. Outcomes of a brief mental health and resilience pilot intervention for young women in an urban slum in Dehradun , North India?: a quasi - experimental study. Int J Ment Health Syst [Internet]. 2018;1–8. Available from: https://doi.org/10.1186/s13033-018-0226-y			The Nae Disha III module is also uploaded for your... [More Details]	384027-(Uploaded-15-05-2022-18-30-22)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically