Plain English Summary
Background and study aims
Each year, one in five adolescents aged 10-19 experiences a mental disorder like depression or anxiety, and the rate is rising. In Nepal, there is a large population of adolescents at risk of mental disorders but a lack of mental health care. An intervention is needed that can protect adolescents from mental disorders, is accessible, cheap and easy to sustain. One such intervention is mental health promotion, which focuses on improving positive behaviours and characteristics that protect mental health.
This study aims to pilot a mental health promotion intervention that uses sport to engage and improve the mental health of adolescents in Nepal. The focus is on sports because there is evidence that sports activities improve mental health, adolescent participation in sports is supported by national and global adolescent policy, and adolescents across Nepal are already playing sports through a national network of sports clubs.
Who can participate?
Adolescents aged between 12-19 years old who are living in the study area
What does the study involve?
The intervention will be implemented over about 10 months in rural Nepal. It involves sports coaching and adolescent clubs and will be open to all adolescents in the study area. The intervention was informed by qualitative research with key stakeholders, the global literature, and the mapping of local resources and interventions. Data on wellbeing and mental health will be collected from adolescents aged 12-19 living in the study clusters whether or not they chose to participate in the intervention. Data will mainly be collected through surveys before and after the intervention and will be used to assess the feasibility and acceptability of the intervention. Data will also give an initial indication of whether the intervention improves adolescents' wellbeing and mental health.
What are the possible benefits and risks of participating?
Adolescents living in the intervention clusters will benefit from access to sports coaching. There are few risks associated with taking part. Survey participants will be asked questions about their mental health which they may find uncomfortable or upsetting. Some minor injuries may happen during the sports activities so coaches will be trained in first aid and familiar with local services to refer adolescents if needed.
Where is the study run from?
1. Transcultural Psychosocial Organization Nepal (Nepal)
2. King’s College London (United Kingdom)
When is the study starting and how long is it expected to run for?
November 2021 to December 2023
Who is funding the study?
UK Research and Innovation (UKRI) (United Kingdom)
Who is the main contact?
1. Dr Nagendra Luitel, npluitel@tponepal.org.np (Nepal)
2. Dr Kelly Rose-Clarke, kelly.rose-clarke@kcl.ac.uk (United Kingdom)
Study website
Contact information
Type
Principal Investigator
Contact name
Dr Kelly Rose-Clarke
ORCID ID
Contact details
Bush House North East Wing
30 Aldwych
London
WC2B 4BG
United Kingdom
+44 (0)20 7848 8811
kelly.rose-clarke@kcl.ac.uk
Type
Principal Investigator
Contact name
Dr Nagendra Luitel
ORCID ID
Contact details
TPO Nepal
Baluwatar
Kathmandu
G.P.O Box 8974/C.P.C. Box 612
Nepal
+977 01 4431717/4437124/4424082
luitelnp@gmail.com
Type
Principal Investigator
Contact name
Dr Nagendra Luitel
ORCID ID
Contact details
TPO Nepal
Baluwatar
Kathmandu
G.P.O Box 8974/C.P.C. Box 612
Nepal
+977 01 4431717/4437124/4424082
npluitel@tponepal.org.np
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
NCT05394311
Protocol/serial number
MR/T040181/1
Study information
Scientific title
Sports coaching and clubs to promote adolescent mental wellbeing in rural Nepal: A pilot cluster-randomised controlled trial - Sports-based Mental heAlth pRomotion for adolescenTs in Nepal (SMART)
Acronym
SMART
Study hypothesis
Sports coaching and adolescent clubs will improve mental wellbeing among adolescents aged 12-19 in rural Nepal
Ethics approval(s)
1. Approved 17/05/2022, Nepal Health Research Council (Ramshah Path, PO Box 7626, Kathmandu, Nepal; +977 1 4254220; nhrc@nhrc.gov.np), ref: 3088
2. Approved 22/04/2022, King’s College London Research Ethics Committee (Franklin Wilkins Building, 5.9 Waterloo Bridge Wing, Waterloo Road, London, SE1 9NH, United Kingdom; +44 (0)20 7848 4020; rec@kcl.ac.uk), ref: HR/DP-21/22-27152
Study design
Community-based pilot cluster-randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Study setting(s)
Community
Study type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Mental wellbeing
Intervention
Randomisation and allocation to the intervention
Four communities of approximately 1000 population (~160 adolescents aged 12-19) will be randomised to the intervention or control arm.
Intervention clusters
The intervention aims to improve adolescent mental wellbeing through:
1. Sports coaching
2. Adolescent clubs
Sports coaching: This will involve weekly sessions for around 90 min, facilitated by a sports coach, teacher, and a youth community mobiliser. Sessions will take place in schools or community sports facilities. Adolescents will be offered coaching in different sports such as football, dance and martial arts/self-defence. Each session will begin with an activity focused on promoting adolescents’ mental wellbeing by building self-esteem, self-efficacy and skills including team building, communication, and interpersonal skills. The activities will include games, role-play, discussions, and relaxation exercises. The remainder of the session will focus on practising sport through drills, training and friendly competitions/matches. Coaching will be open to any adolescent wishing to participate but will target adolescents aged 12-19 living in the study clusters.
Adolescent clubs: These will run in the community and be facilitated by youth community mobilisers (i.e. locally recruited individuals aged 15-24 who are able to mobilise and lead adolescents in the community). Clubs will organise sports tournaments which will engage parents and the wider community and provide opportunities for adolescents to learn livelihood and wellbeing skills. Clubs will be open to all adolescents in the study clusters aged 12-19. Adolescents can attend as many or as few club meetings as they wish.
In control and intervention clusters we will provide mental health training for local health workers including psychoeducation and information about services for referral. We will also distribute sports equipment at the municipality level.
Intervention type
Behavioural
Primary outcome measure
Mental wellbeing measured using the Warwick Edinburgh Mental Wellbeing Scale at baseline and endpoint at 10 months
Secondary outcome measures
All mental health wellbeing outcomes will be measured pre-intervention at baseline and post-intervention at the 10-month endpoint
1. Self-efficacy measured using the Generalized Self-Efficacy Scale
2. Self-esteem measured using the Rosenberg Self Esteem Scale
3. Emotion regulation measured using the Emotion Regulation Questionnaire for Children and Adolescents
4. Social support measured using the Multidimensional Scale of Perceived Social Support
5. Support and empowerment of youth and attachment to the neighbourhood, measured using subscales of the Adolescents’ Developmental Assets in the Neighborhood Scale
6. Depressive symptoms measured using the Depression Self-Rating Scale
7. Anxiety symptoms measured using the Generalised Anxiety Disorder Assessment
Overall study start date
01/11/2021
Overall study end date
31/12/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Any adolescent aged between 12-19 years old, in or out of school, married or unmarried living in the study clusters
Participant type(s)
Healthy volunteer
Age group
Mixed
Lower age limit
12 Years
Upper age limit
19 Years
Sex
Both
Target number of participants
640
Participant exclusion criteria
Adolescents who do not live in the study clusters (e.g. adolescents who live outside the clusters but are visiting friends/family in the study area at the time of the survey)
Recruitment start date
15/09/2022
Recruitment end date
31/10/2023
Locations
Countries of recruitment
Nepal
Study participating centre
Transcultural Psychosocial Organization Nepal
Baluwatar
Kathmandu
G.P.O Box 8974/C.P.C. Box 612
Nepal
Sponsor information
Organisation
King's College London
Sponsor details
Bush House North East Wing
30 Aldwych
London
WC2B 4BG
England
United Kingdom
+44 (0)20 7848 8811
ana.betianu@kcl.ac.uk
Sponsor type
University/education
Website
https://www.kcl.ac.uk/index.aspx
ROR
Funders
Funder type
Government
Funder name
UK Research and Innovation
Alternative name(s)
UKRI
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
Intention to publish date
30/11/2024
Individual participant data (IPD) sharing plan
The data-sharing plans for the current study are unknown and will be made available at a later date
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | 24/08/2023 | 25/08/2023 | Yes | No |