Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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 information initially 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] 307076 0
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 326235 0
social exclusion 326236 0
gender discrimination 326237 0
poor mental health 326238 0
Low resilience 326315 0
Condition category
Condition code
Mental Health 323539 323539 0 0
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] 323529 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331294 0
mental health scores (PHQ9 and GAD 7)
Timepoint [1] 331294 0
18 weeks after starting the course (immediately after completion of the 18 modules of Nae Disha)
Primary outcome [2] 331381 0
resilience scores (CD- RISC 10 )
Timepoint [2] 331381 0
18 weeks after starting the course (immediately after completion of the 18 modules of Nae Disha)
Secondary outcome [1] 409455 0
Gender attitudes (GEMS)
Timepoint [1] 409455 0
18 weeks after starting the course (immediately after completion of the 18 modules of Nae Disha)
Secondary outcome [2] 409456 0
Self efficacy (Schwarzer's General Self-Efficacy Scale)
Timepoint [2] 409456 0
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] 24754 0
India
State/province [1] 24754 0
Uttarakhand

Funding & Sponsors
Funding source category [1] 311386 0
Hospital
Name [1] 311386 0
Herbertpur Christian Hospital
Country [1] 311386 0
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] 312777 0
Individual
Name [1] 312777 0
Pooja S Pillai
Address [1] 312777 0
Herbertpur Christian Hospital, Athan Bagh, Herbertpur, Uttarakhand 248142
Country [1] 312777 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310870 0
Emmanuel Hospital Association Institutional Ethics Committee
Ethics committee address [1] 310870 0
808/92 Deepali Building, Nehru place, New Delhi, 110019
Ethics committee country [1] 310870 0
India
Date submitted for ethics approval [1] 310870 0
16/03/2020
Approval date [1] 310870 0
25/08/2020
Ethics approval number [1] 310870 0
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 119166 0
Mrs Pooja S Pillai
Address 119166 0
Herbertpur christian Hospital,
Athan Bagh, Herbertpur, Dehradun, 248142
Country 119166 0
India
Phone 119166 0
+917300836960
Fax 119166 0
Email 119166 0
poojas.burans@gmail.com
Contact person for public queries
Name 119167 0
Mrs Pooja S Pillai
Address 119167 0
Herbertpur christian Hospital, Athan Bagh,
Herbertpur, Dehradun, 248142
Country 119167 0
India
Phone 119167 0
+917300836960
Fax 119167 0
Email 119167 0
poojas.burans@gmail.com
Contact person for scientific queries
Name 119168 0
Dr Kaaren Mathias
Address 119168 0
University of Canterbury, School of health sciences, Arts road, 8041
Christchurch, New Zealand
Country 119168 0
New Zealand
Phone 119168 0
+642041497530
Fax 119168 0
Email 119168 0
kaaren.mathias@canterbury.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
15970Ethical approval    384027-(Uploaded-08-05-2022-21-31-37)-Study-related document.pdf
16080OtherMathias 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 384027-(Uploaded-08-05-2022-22-24-51)-Basic results summary.docx
Plain language summaryNo Context Implementation was responsive to socio-e... [More Details]

Documents added automatically
No additional documents have been identified.