Development and testing the feasibility of a sports-based mental health promotion intervention in Nepal: a protocol for a pilot cluster-randomised controlled trial.
Adolescent
Community interventions
Low- and middle-income countries
Mental health promotion
Nepal
Sport
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
24 Aug 2023
24 Aug 2023
Historique:
received:
13
03
2023
accepted:
26
05
2023
medline:
25
8
2023
pubmed:
25
8
2023
entrez:
24
8
2023
Statut:
epublish
Résumé
Mental wellbeing encompasses life satisfaction, social connectedness, agency and resilience. In adolescence, mental wellbeing reduces sexual health risk behaviours, substance use and violence; improves educational outcomes; and protects mental health in adulthood. Mental health promotion seeks to improve mental wellbeing and can include activities to engage participants in sport. However, few high-quality trials of mental health promotion interventions have been conducted with adolescents, especially in low- and middle-income countries. We sought to address this gap by testing SMART (Sports-based Mental heAlth pRomotion for adolescenTs) in a pilot cluster-randomised controlled trial (cRCT) in Bardiya, Nepal. The objectives of the trial are to assess the acceptability and feasibility of SMART, test trial procedures, explore outcome distributions in intervention and control clusters and calculate the total annual cost of the intervention and unit cost per adolescent. The trial design is a parallel-group, two-arm superiority pilot cRCT with a 1:1 allocation ratio and two cross-sectional census surveys with adolescents aged 12-19, one pre-intervention (baseline) and one post-intervention (endline). The study area is four communities of approximately 1000 population (166 adolescents per community). Each community represents one cluster. SMART comprises twice weekly football, martial arts and dance coaching, open to all adolescents in the community, led by local sports coaches who have received psychosocial training. Sports melas (festivals) and theatre performances will raise community awareness about SMART, mental health and the benefits of sport. Adolescents in control clusters will participate in sport as usual. In baseline and endline surveys, we will measure mental wellbeing, self-esteem, self-efficacy, emotion regulation, social support, depression, anxiety and functional impairment. Using observation checklists, unstructured observation and attendance registers from coaching sessions, and minutes of meetings between coaches and supervisors, we will assess intervention fidelity, exposure and reach. In focus group discussions and interviews with coaches, teachers, caregivers and adolescents, we will explore intervention acceptability and mechanisms of change. Intervention costs will be captured from monthly project accounts, timesheets and discussions with staff members. Findings will identify elements of the intervention and trial procedures requiring revision prior to a full cRCT to evaluate the effectiveness of SMART. ISRCTN, ISRCTN15973986 , registered on 6 September 2022; ClinicalTrials.gov, NCT05394311 , registered 27 May 2022.
Sections du résumé
BACKGROUND
BACKGROUND
Mental wellbeing encompasses life satisfaction, social connectedness, agency and resilience. In adolescence, mental wellbeing reduces sexual health risk behaviours, substance use and violence; improves educational outcomes; and protects mental health in adulthood. Mental health promotion seeks to improve mental wellbeing and can include activities to engage participants in sport. However, few high-quality trials of mental health promotion interventions have been conducted with adolescents, especially in low- and middle-income countries. We sought to address this gap by testing SMART (Sports-based Mental heAlth pRomotion for adolescenTs) in a pilot cluster-randomised controlled trial (cRCT) in Bardiya, Nepal.
METHODS
METHODS
The objectives of the trial are to assess the acceptability and feasibility of SMART, test trial procedures, explore outcome distributions in intervention and control clusters and calculate the total annual cost of the intervention and unit cost per adolescent. The trial design is a parallel-group, two-arm superiority pilot cRCT with a 1:1 allocation ratio and two cross-sectional census surveys with adolescents aged 12-19, one pre-intervention (baseline) and one post-intervention (endline). The study area is four communities of approximately 1000 population (166 adolescents per community). Each community represents one cluster. SMART comprises twice weekly football, martial arts and dance coaching, open to all adolescents in the community, led by local sports coaches who have received psychosocial training. Sports melas (festivals) and theatre performances will raise community awareness about SMART, mental health and the benefits of sport. Adolescents in control clusters will participate in sport as usual. In baseline and endline surveys, we will measure mental wellbeing, self-esteem, self-efficacy, emotion regulation, social support, depression, anxiety and functional impairment. Using observation checklists, unstructured observation and attendance registers from coaching sessions, and minutes of meetings between coaches and supervisors, we will assess intervention fidelity, exposure and reach. In focus group discussions and interviews with coaches, teachers, caregivers and adolescents, we will explore intervention acceptability and mechanisms of change. Intervention costs will be captured from monthly project accounts, timesheets and discussions with staff members.
DISCUSSION
CONCLUSIONS
Findings will identify elements of the intervention and trial procedures requiring revision prior to a full cRCT to evaluate the effectiveness of SMART.
TRIAL REGISTRATION
BACKGROUND
ISRCTN, ISRCTN15973986 , registered on 6 September 2022; ClinicalTrials.gov, NCT05394311 , registered 27 May 2022.
Identifiants
pubmed: 37620929
doi: 10.1186/s40814-023-01324-z
pii: 10.1186/s40814-023-01324-z
pmc: PMC10464220
doi:
Banques de données
ClinicalTrials.gov
['NCT05394311']
Types de publication
Journal Article
Langues
eng
Pagination
149Subventions
Organisme : Medical Research Council
ID : MR/T040181/1
Pays : United Kingdom
Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
Références
J Am Coll Cardiol. 2018 Sep 18;72(12):1382-1396
pubmed: 30213332
Health Policy Plan. 2016 May;31(4):405-14
pubmed: 26303057
BMC Med Res Methodol. 2013 Sep 18;13:117
pubmed: 24047204
Lancet. 2016 Jun 11;387(10036):2423-78
pubmed: 27174304
Bull World Health Organ. 2016 May 1;94(5):312
pubmed: 27147756
World Psychiatry. 2015 Jun;14(2):207-22
pubmed: 26043339
Epidemiol Psychiatr Sci. 2020 Aug 03;29:e150
pubmed: 32744223
Psychosom Med. 2008 Sep;70(7):741-56
pubmed: 18725425
BMC Public Health. 2011 Jun 21;11:487
pubmed: 21693055
Curr Opin Pharmacol. 2016 Aug;29:34-41
pubmed: 27318753
Glob Health Action. 2020 Dec 31;13(1):1836604
pubmed: 33138740
Lancet. 2004 Sep 11-17;364(9438):970-9
pubmed: 15364188
J Adolesc Health. 2002 Mar;30(3):196-204
pubmed: 11869927
Health Qual Life Outcomes. 2007 Nov 27;5:63
pubmed: 18042300
J Adolesc Health. 2020 Oct;67(4):472-476
pubmed: 32800426
Prev Sci. 2012 Jun;13(3):300-13
pubmed: 22249907
Lancet. 2018 Oct 27;392(10157):1553-1598
pubmed: 30314863
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
Cogn Emot. 2017 Jun;31(4):834-843
pubmed: 27043051
Stat Methods Med Res. 2016 Jun;25(3):1039-56
pubmed: 26071431
J Health Serv Res Policy. 2008 Apr;13(2):92-8
pubmed: 18416914
BMJ Open. 2018 Jul 15;8(7):e020959
pubmed: 30008444
BMJ. 2022 Oct 27;379:e069484
pubmed: 36302546
Lancet. 2010 Apr 3;375(9721):1182-92
pubmed: 20207411
SSM Popul Health. 2022 Dec 27;21:101330
pubmed: 36618545
JAMA Pediatr. 2013 Sep;167(9):816-25
pubmed: 23689475
J Adolesc Health. 2019 Jun;64(6):790-796
pubmed: 31122508
BMC Public Health. 2014 Jun 18;14:619
pubmed: 24943472
Pediatrics. 2016 Sep;138(3):
pubmed: 27542849
Psychol Med. 2020 Jun;50(8):1292-1299
pubmed: 31179962
Biostatistics. 2023 Apr 14;24(2):502-517
pubmed: 34939083
J Pers Assess. 1990 Winter;55(3-4):610-7
pubmed: 2280326
BMJ. 2022 Oct 27;379:e069213
pubmed: 36302526