跳至主要内容
临床试验/NCT05394311
NCT05394311招募中不适用

Developing & Testing the Feasibility of a Sports-based Mental Health Promotion Intervention for Adolescents in Nepal: a Community Engagement Approach

Transcultural Psychosocial Organization Nepal1 个研究点 分布在 1 个国家目标入组 640 人开始时间: 2024年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
640
试验地点
1
主要终点
Change in mental wellbeing of adolescents

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: sports based mental health promotion program (Other)

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.

结局指标

主要结局

Change in mental wellbeing of adolescents

时间窗: From baseline to endline (10 months after the intervention)

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.

次要结局

  • Emotion regulation(Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline)
  • Functional impairment(Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline)
  • 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)
  • 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)
  • Pro-social behaviour(Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline)
  • Resilience(Baseline (T0) before start of the intervention and Endline (T1) 10-month after baseline)

研究者

发起方
Transcultural Psychosocial Organization Nepal
申办方类型
Other
责任方
Sponsor

研究点 (1)

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