Clinical trial NCT05394311: Testing the Feasibility of a Sports-based Mental Health Promotion Intervention for Adolescents in Nepal
Official title: Developing & Testing the Feasibility of a Sports-based Mental Health Promotion Intervention for Adolescents in Nepal: a Community Engagement Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Wellness
Lead sponsor: Transcultural Psychosocial Organization Nepal
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2022-05-27
Enrollment: 640
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Depression and anxiety are the leading contributors to the global burden of disease among young people, accounting for over a third (34.8%) of years lived with disability, and contributing significantly to excess mortality through suicide. Adolescence is the peak age of onset for most mental health conditions, with approximately 50% of lifetime mental health conditions having their onset by mid-adolescence. Adolescent depression in turn predicts several adverse life trajectories, such as failure to complete secondary school, unemployment and unplanned pregnancy or parenthood. Early intervention programmes for adolescents can promote mental health, prevent mental disorders, and prevent risky behaviours and other unhealthy lifestyle choices. These programmes have the potential to make positive contributions to adolescents' health, and to their health in later life. One such intervention is mental health promotion, which focuses on improving positive behaviors and characteristics that protect mental health. Mental health promotion is a strategy to improve the positive behaviors and characteristics that protect mental health

A pilot trial will be conducted to assess the feasibility, acceptability and utility of the intervention and trial design; safety and delivery of the intervention in the community settings; and to identify issues around training, supervision and outcomes measures. A household survey will be conducted at baseline and end line data collection points. After a baseline data collection, the implemention of the intervention will be conducted for around 10 months' period, and then collect the follow-up (end line) data with adolescents.

A parallel-group, two-arm, superiority, cluster-randomised controlled trial with 1:1 allocation to intervention and control arms will be done. In total there will be four clusters (2 control and 2 intervention clusters). The unit of randomization will be a geographic village cluster of \~1000 people (approx 160 adolescents in each cluster). Clusters will be separated geographically which will mitigate risk of contamination in the control arm. A researcher will visit each household in the clusters and ask if there are any adolescents living in the household. Where appropriate consent is obtained, the researcher will then interview eligible adolescents using a smartphone or tablet pre-programmed with the survey. The main trial analysis will be a cross-sectional comparison of data from the endline survey, adjusted for baseline differences. Intervention activities will be open to all adolescents aged 12-19 living in the community to participate. The acceptability of the intervention, randomisation, tools, uptake, utility of the intervention, facilitators' fidelity to the manual, mental health outcome trends, and cost of design and delivery of the intervention will be assessed. The intervention process data will be also collected. This will include FGDs and interviews with adolescents and their parents, facilitators and trainers to explore feasibility and acceptability of the intervention and study procedures.

Eligibility criteria: Inclusion Criteria:

1. Any adolescent boy or girl aged 12-19 years
2. Adolescents in or out of school
3. Married or unmarried
4. Who lives in the study clusters
5. Able to speak and listen

Exclusion Criteria:

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

Primary outcomes:
measure: Change in mental wellbeing of adolescents
timeFrame: From baseline to endline (10 months after the intervention)
Secondary outcomes:
measure: Self-efficacy
timeFrame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
measure: Self-esteem
timeFrame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
measure: Emotion regulation
timeFrame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
measure: Depression
timeFrame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
measure: Anxiety
timeFrame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
measure: Resilience
timeFrame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
measure: Functional impairment
timeFrame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
measure: Pro-social behaviour
timeFrame: Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline
Other outcomes:
Locations:
city: Biratnagar
country: Nepal
facility: Patharisanischare municiaplity and Kanepokhari rural municipality
state: Koshi
Study officials:
affiliation: Transcultural Psychosocial Organization Nepal
name: Kamal Gautam, MD
role: STUDY_DIRECTOR
References: