Testing the Feasibility of a Sports-based Mental Health Promotion Intervention for Adolescents in Nepal

NCT05394311 | Recruiting DMC

• 1 other identifier: MR/T040181/1
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief Summary

Each year, one in five adolescents experiences a mental disorder like depression or anxiety, and the rate is rising. Depression is a common mental disorder, one of the leading global causes of Disability Adjusted Life Years among adolescents, and can lead to learning, behavioural and social impairment, as well as comorbid cardiovascular disease and mental illness in adulthood. An intervention is needed that can protect adolescents from mental disorders, is accessible to all adolescents, and is cheap and easy to sustain. One such intervention is mental health promotion, which focuses on improving positive behaviors and characteristics that protect mental health. There is already a strong evidence base for treatment and indicated prevention approaches, but a lack of research on mental health promotion interventions. In low resourced settings like Nepal, interventions need to be short of duration, and be carried out by lay people in the communities to make them sustainable and feasible to implement on a broader scale. The aim of this study is to develop and test the feasibility and acceptability of an intervention that uses sports groups to engage and improve the mental health of adolescents in Nepal.

Conditions

Mental Health Wellness

Outcome Measures

Primary Outcomes (1)

• Change in mental wellbeing of adolescents

  Mental wellbeing is a marker of mental health promotion and defined as subjective evaluation of life satisfaction. This will be measured using the Warwick Edinburgh Mental Wellbeing Scale. The scale is scored by summing responses to each item answered on a 1 to 5 Likert scale where '1' indicates 'none of the time' and '5' indicates 'all of the time'. The minimum scale score is 14 and the maximum is 70 with with higher scores indicating a higher level of mental wellbeing.

  From baseline to endline (10 months after the intervention)

Secondary Outcomes (8)

• Self-efficacy

  Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline

• Self-esteem

  Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline

• Emotion regulation

  Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline

• Depression

  Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline

• Anxiety

  Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline

Study Arms (2)

Intervention arm - sport based mental health promotion program

EXPERIMENTAL

The experimental arm will receive an intervention for around 10 months' period after baseline data collection.

Other: sports based mental health promotion program

Control group - treatment as usual

NO INTERVENTION

This group receive the intervention available in the existing health care and education system in the study area.

Interventions

sports based mental health promotion program OTHER

sports related programs

Also known as: sports related program

Intervention arm - sport based mental health promotion program

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Any adolescent boy or girl aged 12-19 years
• Adolescents in or out of school
• Married or unmarried
• Who lives in the study clusters
• Able to speak and listen

You may not qualify if:

• Participants who are unable to provide a written consent
• People having severe mental illness or severe physical disability
• Participants who are planning to move from the study sites during the study period

Sponsors & Collaborators

• Transcultural Psychosocial Organization Nepal: lead
• King's College London: collaborator

Study Sites (1)

Patharisanischare municiaplity and Kanepokhari rural municipality

Biratnagar, Koshi, 56600, Nepal

RECRUITING

Related Publications (1)

• Rose-Clarke K, Rimal D, Morrison J, Pradhan I, Hodsoll J, Jaoude GA, Moore B, Banham L, Richards J, Jordans M, Prost A, Lamichhane N, Regmee J, Gautam K, Luitel NP. Development and testing the feasibility of a sports-based mental health promotion intervention in Nepal: a protocol for a pilot cluster-randomised controlled trial. Pilot Feasibility Stud. 2023 Aug 24;9(1):149. doi: 10.1186/s40814-023-01324-z.

  PMID: 37620929 DERIVED

Study Officials

• Kamal Gautam, MD

  Transcultural Psychosocial Organization Nepal

  STUDY DIRECTOR

Central Study Contacts

Nagendra Luitel, PhD

CONTACT

9841333725; luitelnp@gmail.com

Kelly Clarke, PhD

CONTACT

kelly.rose-clarke@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A parallel-group, two-arm, superiority, cluster-randomised controlled trial with 1:1 allocation to intervention and control arms will be used in the study. Two cross-sectional household surveys of adolescents, one at baseline and one at end line will be conducted.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 27, 2022
• Study Start: July 15, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)